FDA承認新薬一覧データ:CDER

　→●FDA承認新薬一覧データ:CBER　はこちら。

　"The Medical Letter on Drugs and Therapeutics"はFDA承認新薬は、すべて評価する
ことが原則となっている。
 日本語版の版元として、本当にそうなのか？　知りたい．．．
 また、特定疾病領域のレビュー、トピック検証記事、新薬評価の比率とかの内容構成は
どうなっているのか？　把握しておこうというのが発端だった。

　新薬に関しては、日本でもそうだが、いくつかの段階があり、またFDAの審査部門とし
ても、CDERと、CBER(生物製剤、血液、バイオ)とに分けられている。

 今回は、CDER,CBERの新薬リストとMedical Letter収載号を付き合わせてみた結果を提示。
 「新薬」に関しては、新規化合物[NME]については完全に付き合わせたけれどもNDA全体
 の表は、適応追加、配合剤などを多く含むため参考程度にチェックした。

 尚、The Medical Letter誌で、この新薬リスト外の記事が多く収録されているが、それ
は、特定疾病領域のレビュー、トピック検証記事。


●医薬品承認の仕組み

日本と同様に、FDAでも医療用医薬品[Rx]と一般用医薬品[OTC]に分かれ、
新薬[NME=New Molecular Entities]とジェネリック[Abbreviated application ]、
効能追加[Efficacy Supplements]等までは良かったが、
迅速承認[NDA Accelerated Approvals]、User Free, Approvable Letter
等日本にない制度が出てくると、一応まとめておいた方がいいと考えた。
 *現在は日本も、医薬品医療機器機構の拡充整備が進み、何かと疑惑が噂されるFDA
より優る点も多い。

●User Fee
〜審査に要する費用を申請者が負担すれば、迅速手続きを行う法案。
FDA - Office of Commissioner - Prescription Drug User Fees[PDUFA][A= Amendments]
には、関連データの他、議会に対するAnnual Reports - Performanceに中で、審査期間や経過について
詳細な報告を行っている。
　日本では議会が殆ど機能していないので、厚労省には同様のデータがない。


●Approvable Letter(承認可能通知)
〜これはFDAが審査の最終段階で申請企業に対して発行する文書
[CFR Title21] SUBCHAPTER D - DRUGS FOR HUMAN USE PART 314 -- APPLICATIONS FOR 
FDA APPROVAL TO MARKET A NEW DRUG
 - Approvable letter は、特定の情報、データ等の要件が満たされれば、承認すると
　　いう内容の文書。
   (期間については特に定めていない。)

●米製薬協　日本事務所
 - [米製薬協]New Drugs 2004[pdf,22p]
 では毎年のFDA承認新薬のリストと共に、各製品毎の解説と新薬承認制度の解説を
 日本語で行っている。　これは米国版の翻訳版


(途中)


●メモ

●[FDA-CDER]Pediatric Drug Development
 - Summary of Medical and Clinical Pharmacology Reviews of Pediatric Studies
   - 各新薬の小児適応追加申請データ[Medical Review][Clinical Pharmacology]が公開

●CDER Drug and Biologic Approval Reports[2004以降]
　Efficacy Supplement Approvals [2005]
  - 新薬の適応追加一覧〜[成分名]... [申請日][承認日][適応症]




●関連製品　医療用具

　医療用具の承認プロセスは、→Getting To Market With A Medical Device

 Title 21 Code of Federal Regulations Part 800-1200 (21 CFR Parts 800 - 1299)
Federal Food Drug & Cosmetic (FD&C) Act - general controls
 において、医療用具は、規制を受ける。
　市販承認プロセスには、３つのステップがあって、
　1)FD&C Actのsection 201(h)に定義されるものか確認
　2)分類　〜この分類により、市販前届出premarket notification [510(k)] かあるいは
　　　　　　市販前承認premarket approval (PMA)かの手続きを選択する。
　3)追加データ　〜[510(k)]の一部とPMA applicationsの大半で、臨床データが要求され
　　　　　　　　、これらの試験はInvestigational Device Exemption (IDE) regulation
　　　　　　に従って実施される必要がある。
※詳細解説
510k Information
PMA Information
Exempt Device Information


●FDA -CDRH -Recent Device Approvals
 --- http://www.fda.gov/cdrh/consumer/mda/index.html
　　★Recently Approved Devices[2000.5-以降]の承認製品リスト[日付順][名称順][分類順]〜詳細リンクあり
　　 A510(k)該当製品　−PMA以前
　　 Search the 510(k) Database　全製品検索
　　 Monthly listing of 510(k)s　月次製品リスト
　　 PMA該当製品　−市販前申請品目
　　 Search the PMA Database　全製品検索
　　 Monthly listing of PMAs　月次製品リスト
　　★Device Listing Database　承認製品DB検索

■FDA承認新薬：CDER管轄

　From FDA-CDER: Drug and Biologic Approval Reports
  (Biologicは2004〜)
●検索は　Drug Approval Reports by Month

●最近承認された新薬は　　New and Generic Drug Approvals




●Fast Track Reports★品目リスト[明細別記]
・Approvals 1998.9.17-2007.3.13
 Fast Track Designated Products Approved (Updated through 9/30/2005, Posted 9/30/2005)
・Statistics (Fiscal year)[略]
 - 処理日数、申請数に対する承認、却下、保留などの内訳


●NME Drug and New Biologic Approvals★品目リスト[明細別記]
(New Molecular Entities (NMEs) Reports)
・
・NME Drug and New Biologic Approvals in 2009
 (Updated through 6/30/2009)
・NME Drug and New Biologic Approvals in 2008
 (Updated through 11/30/2008)
・NME Drug and New Biologic Approvals in 2007
 (Updated through 12/30/2007, Posted 4/30/2009)
・NME Drug and New Biologic Approvals in 2006
 (Updated through 12/19/2006, Posted 4/30/2009)
・NME Drug and New Biologic Approvals in 2005
 (Updated through 12/31/2005, Posted 4/30/2009)
・NME Drug and New Biologic Approvals in 2004
 (Updated through 12/31/2004, Posted 4/30/2009)
・New Molecular Entities (NMEs) Approved in Calendar Year 2003
 (Updated through 12/31/2003, Posted 4/30/2009)
・New Molecular Entities (NMEs) Approved in Calendar Year 2002
 (Updated through 12/31/2002, Posted 4/30/2009)
・New Molecular Entities (NMEs) Approved in Calendar Year 2001
 (Updated through 12/31/2001, Posted 4/30/2009)
・New Molecular Entities (NMEs) Approved in Calendar Year 2000 (Updated 4/30/2009)
・New Molecular Entities (NMEs) Approved in Calendar Year 1999 (Updated 4/30/2009)


●Priority NDA and BLA Approvals★品目リスト[明細別記]
(旧Fiscal Year User Fee Priority Approvals)

CDER Priority NDA and BLA Approvals in 2009[-2009.6.30]
CDER Priority NDA and BLA Approvals in 2008
CDER Priority NDA and BLA Approvals in 2007
CDER Priority NDA and BLA Approvals in 2006[-2006.12.28迄;最終更新2007.4.10]
CDER Priority NDA and BLA Approvals in 2005
CDER Priority NDA and BLA Approvals in 2004
CDER Priority NDA Approvals in Calendar Year 2003
CDER Priority NDA Approvals in Calendar Year 2002
CDER Priority NDA Approvals in Calendar Year 2001
CDER Priority NDA Approvals in Calendar Year 2000


●Approval Times (In Months) for Priority and Standard NMEs and NDAs (In Months)★統計値
 - ここでは新薬の審査・承認平均所要月数を年度毎・(優先・通常)別に統計。
・New Drug Applications (NDAs) & Biologic License Applications (BLAs) 
 - Approval Times for Priority and Standard NDAs and BLAs  Calendar Years 1993 - 2006 *更新2006.12.31
・New Molecular Entity Drugs (NMEs) & New Biologics (New BLAs)
 -CDER Approval Times for Priority and Standard NMEs and New BLAs Calendar Years 1993 - 2006 *更新2006.12.31

●NDA and BLA Approvals★品目リスト[明細別記]
New Drug Approvals by Calendar Year
・NDA and BLA Approvals in 2009 (Updated through 6/30/2009)
・Drug and Biologic Approvals for Calendar Year 2008 (Updated through 9/30/2008, Posted 11/3/2008)
・Drug and Biologic Approvals for Calendar Year 2007 (Updated through 12/31/2007, Posted 8/6/2007)
・Drug and Biologic Approvals for Calendar Year 2006 (Updated through 12/31/2006, Posted 5/8/2007)
・Drug and Biologic Approvals for Calendar Year 2005 (Updated through 12/31/2005, Posted 3/30/2006)
・Drug and Biologic Approvals for Calendar Year 2004 (Updated through 12/31/2004, Posted 8/11/2005)
・NDA Approvals for Calendar Year 2003 (Updated through 12/31/2003, Posted 1/21/2004)
・NDA Approvals for Calendar Year 2002 (Updated through 12/31/2002, Posted 1/14/2003)
・NDA Approvals for Calendar Year 2001 (Updated through 12/31/2001, Posted 7/15/2002)
・NDA Approvals for Calendar Year 2000(Updated 4/19/2002)
・NDA Approvals for Calendar Year 1999 (Updated 4/19/2002)
・NDA Approvals for Calendar Year 1998 (Updated 4/6/2001)
　このリストの統計数値は、下記
※New Drug Applications Approved by Therapeutic Potential and Chemical Types★統計値
を参照のこと。



●Efficacy Supplement Approvals★品目リスト[明細略]
(旧Efficacy Supplements Approved in Calendar Year)　四半期毎に更新


・New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2005)[最終更新2005.12.2]
・New Drug Application (NDA) & Biologic License Application (BLA) Efficacy Supplements Approved (CY 2004)[最終更新2004.12.31]
・Efficacy Supplements Approved in Calendar Year 2003
 (Updated through 12/31/2003, Posted 3/19/2004)
・Efficacy Supplements Approved in Calendar Year 2002
 (Updated through 12/31/2002, Posted 1/14/2003)
・Efficacy Supplements Approved in Calendar Year 2001
 (Updated through 12/31/2001, Posted 10/24/2002)
・Efficacy Supplements Approved in Calendar Year 2000
(Updated 3/19/2002)
・Efficacy Supplements Approved in Calendar Year 1999
(Updated 3/19/2002)
・Efficacy Supplements Approved in Calendar Year 1998(Posted 3/19/2002)

Supplement Type Description
N Type 6 NDA - New indication 
SE1 New or modified indication (適応追加)
SE2 New dosage regimen (用法用量変更)
SE3 New route of administration (投与経路追加)
SE4 Comparative efficacy claim 
SE5 Patient population altered 
SE6 Change the marketing status from prescription to over-the-counter use 
SE7 Complete the traditional approval of a product originally approved under sub
part H (accelerated approval) 
SE8 Incorporate other information based on at least one adequate and well-controlled clinical study 


●Accelerated and Restricted Approvals under subpart H/E★品目リスト[明細別記]
・NDAs
  Approved under Subpart H (Updated through 12/31/2005, Posted 3/31/2006)
・NDA Supplements
  Approved under Subpart H (Updated through 12/31/2005, Posted 3/31/2006)
・BLAs
  Biological Products Approved under Subpart E(Updated through 12/31/2005, Posted 3/30/2006)
・BLA Supplements
  Approved under Subpart E(Updated through 12/31/2005, Posted 3/31/2006)



●New Drug Applications Approved by Therapeutic Potential and Chemical Types★統計値
・NDAs Approved in Calendar Years 1990-2004 by Therapeutic Potential and Chemical Types
 (Updated through 12/31/2004, Posted 3/22/2005)
　NDA件数を新医薬品区分(新規成分、剤型追加、配合剤など)別に集計

●Number of NDAs Received by Calendar Year★統計値
・Number of NDAs Received by Calendar Year
(Updated 3/22/2005)




●First Action Performance Reports★統計値
 - 申請に対して、承認、拒否、取り下げなどの統計
・First Action Performance For Original NDAs 
 - (Updated through 11/12/2004)
・First Action Performance For Resubmitted NDAs 
 - (Updated through 11/12/2004)
・First Action Performance For Original Efficacy Supplements
 - (Updated through 11/12/2004)
・First Action Performance For Efficacy Supplements Resubmitted
 - (Updated through 11/12/2004)
・First Action Performance For Original Manufacturing Supplements
 - (Updated through 11/12/2004)



●Approval Rates by Cohort Year of Receipt (Fiscal Years)
  承認迄の所要審査期間のグラフ[36カ月迄]；
  CDER Priority NDAs & BLAs (FY 98-04)[pdf]
  CDER Standard NDAs & BLAs (FY 98-04)[pdf]


●IND Reports★統計値
(旧Investigational New Drugs (INDs) Reports)
http://www.fda.gov/cder/rdmt/cyactind.htm
・Active Investigational New Drugs (INDs) at the Close of the Calendar Year - Calendar Years 1986-2004
 (Updated through 12/31/2004)
 - List of active Commercial and Non-Commercial Investigational New Drugs at 
the close of each Calendar Year beginning with 1986 through 2004
・Original INDs Received Calendar Years 1986 - 2004
 (Updated 12/31/2004)
 - Total number of Commercial and Non-Commercial Investigational New Drugs
received in each calendar year beginning with 1986 through 2004

---

■NDA and BLA Approvals

★〜2008は消去された。[2009.11.10確認]
 By Calendar Year;   NDA & BLA(2004〜)
Updated through September 30, 2008; 整列＝承認日順
CT=CHEMICAL TYPE  RC=Review Classification
NDA Chemical Type:
1 -   New molecular entity　新規物質
2 -   New ester, new salt, or other noncovalent derivative
　　　(新しいエステル、塩または他の非共有結合誘導体)
3 -   New formulation　新剤型
4 -   New combination　配合剤
5 -   New manufacturer　新メーカー
　　　*これは、一部変更扱いの申請者や製造者の変更ではない。
　　　大雑把にいうと、先発メーカーが既に承認を取得している医薬品を、
　　　別のメーカーが新しい製法等で申請するケース。
　　　[例] Glumetza (塩酸メトホルミン持効錠)[Biovail Labs社]5S 承認=03-Jun-2005
      本剤は、03-Jun-2008迄の先発権を賦与されたが、ポリマーベースの経口DDS製剤で
　　　metformin HClを上部消化管に運ぶシステム。適応は２型糖尿病で１８才以上の成
　　　人の単独および併用療法。
　　　一方、先発品Glucophage Tabs& XR Tabs[BMS]。XRはdual hydrophilic polymer
     matrix system使用。適応は２型糖尿病で単独療法の場合Glucophage Tabsは１０才
　　　以上、XRは１７才以上の成人。　併用療法は共に１７才以上。
7 -   Drug already marketed, but without an approved NDA

Review Classification:  
P -   Priority Review - 優先処理
Significant improvement compared to marketed products, in the treatment, diagnos
is, or prevention of a disease.
S -   Standard Review - 通常処理
Products that do not qualify for priority review.
O -  Orphan Designation - オーファン指定
Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

●Drugs and Biologic APPROVALS FOR CALENDAR YEAR 2009
Updated through June 30, 2009
New Drug Application (NDA) Approvals:
ML	Application Type	Application Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	505B2 FLAG	Approval Date
	N●	022256	SAVELLA	MILNACIPRAN HYDROCHLORIDE	CYPRESS BIOSCIENCE	1	S		14-Jan-09
			Fibromyalgia(線維筋痛症) ・本剤はSNRI系抗うつ薬として1998年以来販売されている。　Cypress Bioscienceは創製企業Pierre Fabreから米国・カナダの開発販売権を2003年に取得。 繊維筋痛症治療薬として開発。　Forest Laboratoriesと共同開発。　本剤は日本ではトレドミン[旭化成ファーマ/. ヤンセンファーマ]の商品名で抗うつ剤として販売。
	N	022087	VERTICAL	CALCITRIOL	GALDERMA	3	S		23-Jan-09
			a Novel Topical Therapy for Mild-to-Moderate Plaque Psoriasis ※日本ではロカルトロールカプセル、注[中外製薬他]骨粗鬆症(経口)、維持透析下の二次性副甲状腺機能亢進症(注)
	N	022204	GELNIQUE	OXYBUTYNIN CHLORIDE	WATSON	3	S		27-Jan-09
	N	022287	KAPIDEX	DEXLANSOPRAZOLE	TAKEDA	2	S		30-Jan-09
	N	021856	ULORIC	FEBUXOSTAT	TAKEDA	1	S		13-Feb-09
	N	050818	TOBRADEX ST	TOBAMYCIN/ DEXAMETHASONE	ALCON	3	S	Y	13-Feb-09
	N●	022370	CIP-TRAMADOL ER capsules(TRAMADOL HYDROCHLORIDE)	TRAMADOL HYDROCHLORIDE	CIPHER　Pharmaceutical	3	S		13-Feb-09
			indicated for the management of moderate to moderately severe chronic pain such as osteoarthritis/徐放性及び速放性/※日本はトラマール注100[日本新薬株式会社]
	N●	022278	MEMBRANEBLUE	TRYPAN BLUE	蘭DORC INTERNATIONAL	5	P		20-Feb-09
			1)For use as an aid in ophthalmic posterior surgery(後眼房の手術);　2)Facilitating removal of epiretinal tissue.(網膜組織除去補助)
	N	022277	TEMODAR	TEMOZOLOMIDE	SCHERING	3	S		27-Feb-09
	N●	021997	Edluar (formerly known as Sublinox) /ZOLPIDEM TARTRATE	ZOLPIDEM TARTRATE	OREXO AB	3	S		13-Mar-09
			fast-acting, sublingual formulation of the well-known substance zolpidem and has been approved for the temporary treatment of insomnia.
	N	022347*	STAVUDINE/LAMIVUDINE	30MG/150MG & 40MG/150MG TAB	PHARMACARE LTD	4	S		18-Mar-09
	N	022334	AFFINITOR	EVEROLIMUS	NOVARTIS	1	P		30-Mar-09
	N	022268	COARTEM	ARTEMETHER/ LUMEFANTRINE	NOVARTIS	1	P,O		07-Apr-09
	N	022129	PHYXXLICE	BENZYL ALCOHOL	SCIELE PHARMA	1	P		09-Apr-09
			First Prescription Non-Neurotoxic Head Lice※同社は2008.10塩野義が買収
	N	022154	TYZEKA	TELBIVUDINE	NOVARTIS	3	S		28-Apr-09
	N●	020725	CREON	PANCRELIPASE	SOLVAY	7	P		30-Apr-09
			for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions;
	N	022314	EXFORGE HCT	AMLODIPINE/VALSARTAN/HYDROCHLOROTHIAZIDE	NOVARTIS	4	S	Y	30-Apr-09
	N	021918	CETRAXAL	CIPROFLOXACIN OTIC SOLUTION	LABORATORIOS SALVAT	3	S	Y	01-May-09
	N	020866	CYCLOSET	BROMOCRIPTINE MESYLATE	VEROSCIENCE	3	S	Y	05-May-09
	N	022192	FANAPT	ILOPERIDONE	VANDA PHARMS INC	1	S		06-May-09
	N	022251	LAMICTAL ODT	LAMOTRIGINE	SMITHKLINE BEECHAM	3	S		08-May-09
	N	022024	ACTOPLUS MET XR	PIOGLITAZONE HYDROCHLORIDE/METFORMIN HYDROCHLORIDE	TAKEDA GLOBAL	3	S		12-May-09
	N	022327	PREVACID 24 HR	LANSOPRAZOLE	NOVARTIS CONS	5	S		18-May-09
	N	022360	NICORETTE	NICOTINE POLACRILEX	GLAXOSMITHKLINE CONS	5	S		18-May-09
	N	022275	SAMSCA	TOLVAPTAN	OTSUKA AMERICA PHARM	1	S		19-May-09
	N	022160*	OXALIPLATIN INJECTION	OXALIPLATIN INJECTION	TEVA PARENTERAL	5	S		22-May-09
	N	022308	BESIVANCE	BESIFLOXACIN	BAUSCH AND LOMB	1	S		28-May-09
	N	022115	LAMICTAL XR	LAMOTRIGINE	SMITHKLINE BEECHAM	3	S		29-May-09
	N	022348	CALDOLOR	IBUPROFEN	CUMBERLAND PHARMS	5	P	Y	11-Jun-09
	N	022202	ZIPSOR	DICLOFENAC POTASSIUM	XANODYNE PHARMS INC	3	S	Y	16-Jun-09
	N	022165	CAMBIA	DICLOFENAC	PROETHIC PHARMS	3	S	Y	17-Jun-09
	N	022315	OZURDEX	DEXAMETHASONE INTRAVITREAL IMPLANT	ALLERGAN	3	P		17-Jun-09
	N	022180	FERAHEME	FERUMOXYTOL	AMAG PHARMS INC	2	S		30-Jun-09
* NDA 22-370, TRAMADOL HYDROCHLORIDE, HAS BEEN TENTATIVELY APPROVED. * NDA 22-347,STAVUDINE/LAMIVUDINE, HAS BEEN TENTATIVELY APPROVED. * NDA 22-160, OXALIPLATIN, HAS BEEN TENTATIVELY APPROVED.
	N	022425	MULTAQ	DRONEDARONE HYDROCHLORIDE	1	P	SANOFI AVENTIS US	07/01/2009
	N	022306	SOTALOL HYDROCHLORIDE	SOTALOL HYDROCHLORIDE	3	,O	ACADEMIC PHARMS	07/02/2009
	N	021998	PLAN B ONE-STEP : Prescription/Over-the-counter	LEVONORGESTREL	3	S	DURAMED	07/10/2009
	N	022307	EFFIENT	PRASUGREL HYDROCHLORIDE	1	P	ELI LILLY AND CO	07/10/2009
	N	022239	SUMAVEL DOSEPRO	SUMATRIPTAN SUCCINATE	3	S	ZOGENIX INC	07/15/2009
	N	022266	ONSOLIS	FENTANYL CITRATE	3	S	MEDA PHARMS	07/16/2009
	N	022342	STAVUDINE; LAMIVUDINE; NEVIRAPINE	STAVUDINE; LAMIVUDINE; NEVIRAPINE			EMCURE PHARMA	07/16/2009
	N	022402	CODEINE SULFATE	CODEINE SULFATE	7	S	ROXANE	07/16/2009
	N	022427	ACUVAIL	KETOROLAC TROMETHAMINE	5		ALLERGAN	07/22/2009
	N	022294	ZIDOVUDINE	ZIDOVUDINE			AUROBINDO PHARMA	07/23/2009
	N	022296	LAMIVUDINE; ZIDOVUDINE	LAMIVUDINE; ZIDOVUDINE			AUROBINDO PHARMA LTD	07/23/2009
	N	022429	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE			BANNER PHARMACAPS	07/23/2009
	N	022429	CETIRIZINE HYDROCHLORIDE HIVES	CETIRIZINE HYDROCHLORIDE			BANNER PHARMACAPS	07/23/2009
	N	022352	COLCRYS	COLCHICINE			AR HOLDING CO INC	07/29/2009
	N	022351	COLCRYS	COLCHICINE			MUTUAL PHARMA	07/30/2009
	N	022387	TYVASO	TREPROSTINIL SODIUM			UNITED THERAP	07/30/2009
	N	022264	INVEGA SUSTENNA	PALIPERIDONE PALMITATE			JOHNSON AND JOHNSON	07/31/2009
	N	022350	ONGLYZA	SAXAGLIPTIN HYDROCHLORIDE			BRISTOL MYERS SQUIBB	07/31/2009
	N	022436	ACYCLOVIR AND HYDROCORTISONE	ACYCLOVIR; HYDROCORTISONE			MEDIVIR	07/31/2009

New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):
ML	Application Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	505B2 FLAG	Approval Date
	022346*	STAVUDINE/LAMIVUDINE/NEVIRAPINE	STAVUDINE/LAMIVUDINE/NEVIRAPINE	PHARMACARE	4	S	Y	27-Feb-09
	022356*	LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE	LAMIVUDINE/ZIDOVUDINE/NEVIRAPINE	HETERO DRUGS LTD	4	S		07-May-09
* NDA 22-346,STAVUDINE/LAMIVUDINE/NEVIRAPINE , HAS BEEN TENTATIVELY APPROVED UNDER PEPFAR. * NDA 22-356, LAMIVUDINE/ZIDOVUDINE, HAS BEEN TENTATIVELY APPROVED UNDER PEPFAR.

Biologic License Application (BLA) Approvals:
ML	BLA Number	Proprietary Name	Proper Name	Applicant	Review Classification	Approval Date
	L 125289/0.0	GOLIMUMAB	SIMPONI	CENTOCOR ORTHO BIOTECH	S	24-Apr-09
the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis(強直性脊椎炎).
	L 125274/0.0	ABOBOTULINUMTOXIN A	DYSPORT	IPSEN BIOPHARM LIMITED	S	29-Apr-09
	L 125319/0.0	CANAKINUMAB	ILARIS	NOVARTIS PHARMACEUTICALS CORPORATION	P	17-Jun-09
NDA Chemical Type: 1 - New molecular entity 2 - New ester, new salt, or other noncovalent derivative 3 - New dosage form 4 - New combination - New formulation or new manufacturer 5 - Drug already marketed, but without an approved NDA 7 - OTC switch Review Classification: P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease. S - Standard Review - Products that do not qualify for priority review. O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

●Drugs and Biologic APPROVALS FOR CALENDAR YEAR 2008
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	505(b)(2)	APPROVAL DATE
	021658	ALVESCO	CICLESONIDE	NYCOMED	3	S	Y	10-Jan-08
	022067	FLO-PRED	PREDNISOLONE ACETATE	TARO	3	S	Y	17-Jan-08
	022187	INTELENCE	ETRAVIRINE	TIBOTEC	1	P		18-Jan-08
	022107	TEKTURNA HCT	ALISKIREN/HYDROCHLOROTHIAZIDE	NOVARTIS	4	S		18-Jan-08
	021538	ACCRETROPIN	SOMATROPIN	CHESAPEAKE	5	S	Y	23-Jan-08
	050813	MOXATAG	AMOXICILLIN	MIDDLEBROOK	3	S	Y	23-Jan-08
	022023	EMEND	FOSAPREPITANT DIMEGLUMINE	MERCK & CO	2	S	Y	25-Jan-08
	022157	XYZAL	LEVOCETIRZINE DIHYDROCHLORIDE	UCB, INC.	3	S		28-Jan-08
	022078	SIMCOR	NIACIN/SIMVASTATIN	ABBOTT	4	S	Y	15-Feb-08
	022029	SALONPAS	METHYL SALICYLATE & MENTHOL	HISAMITSU	3,4	S	Y	20-Feb-08
	022028	COSYNTROPIN	COSYNTROPIN	SANDOZ	5	S	Y	21-Feb-08
	022101	NEXIUM	ESOMEPRAZOLE MAGNESIUM	ASTRAZENECA	3	S		27-Feb-08
	022033	LUVOX CR	FLUVOXAMINE MALEATE	SOLVAY	3	S	Y	28-Feb-08
	021992	PRISTIQ	DESVENLAFAXINE SUCCINATE	WYETH	1	S		29-Feb-08
	020140	ISOVORIN	LEUCOVORIN CALCIUM	SPECTRUM	5	S,O		07-Mar-08
	022195	MORPHINE SULPHATE	MORPHINE SULPHATE	ROXANE	7	S	Y	17-Mar-08
	022207	MORPHINE SULFATE	MORPHINE SULFATE	ROXANE	7	S	Y	17-Mar-08
	022056	PRILOSEC	OMEPRAZOLE	ASTRAZENECA	3	S		20-Mar-08
	022249	TREANDA	BENDAMUSTINE HYDROCHLORIDE	CEPHALON	1	P,O	Y	20-Mar-08
	022009	ANTHELIOS 40	AVOBENZENE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE	L'OREAL	5	S	Y	31-Mar-08
	022161	LEXISCAN	REGADENOSON	CV THERAPEUTICS	1	S		10-Apr-08
	022235	LUVOX	FLUVOXAMINE MALEATE	JAZZ	3	S	Y	14-Apr-08
	021926	TREXIMET	SUMATRITAM; NAPROXEN SODIUM	POZEN	4	S	Y	15-Apr-08
	021861	PATANASE	OLOPATADINE HYDROCHLORIDE	ALCON	3	S	Y	15-Apr-08
	022108	APLENZIN	BUPROPION HYDROBROMIDE	BIOVAIL LABS	2	S	Y	23-Apr-08
	021964	RELISTOR	METHYLNALTREXONE BROMIDE	PROGENICS	1	S		24-Apr-08
	021795	MINIRIN	DESMOPRESSIN ACETATE	FERRING	5	S	Y	08-May-08
	022185	TACLONEX SCALP	CALCIPOTRIENE; BETAMETHASONE DIPROPIONATE	LEO PHARM PRODUCTS	3	S	Y	09-May-08
	022159	ORAVERSE	PHENTOLAMINE MESYLATE	NOVALAR	3	S	Y	09-May-08
	021775	ENTEREG	ALVIMOPAN	ADOLOR	1	S	Y	20-May-08
	022104	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	OSMOTICA	3	S	Y	20-May-08
	021830	ASACOL	MESALAMINE	PROCTOR AND GAMBLE	3	S	Y	29-May-08
	022008	REQUIP XL	ROPINIROLE	SMITHKLINE BEECHAM	3	S		13-Jun-08
	021952	CLARITIN LIQUI-GELS	LORATADINE	SCHERING-PLOUGH	3	S	Y	16-Jun-08
	022220	TRIVARIA	TRIAMCINOLONE ACETONIDE	ALLERGAN	3	S	Y	16-Jun-08
	021822	APTIVUS	TIPRANAVIR	BOEHRINGER INGELHEIM	3	P	Y	23-Jun-08
	022212	DUREZOL	DIFLUPREDNATE	SIRION	1	P		23-Jun-08
	022292	APTIVUS	TIPRANAVIR	BOEHRINGER INGELHEIM	3	P	Y	23-Jun-08
	022386	PRANDIMET	REPAGLINIDE/METFORMIN HYDROCHLORIDE	NOVO NORDISK	4	S	Y	23-Jun-08
	022260	EPOPROSTENOL SODIUM	EPOPROSTENOL SODIUM	GENERAMEDIX	5	S	Y	27-Jun-08
	022090	EOVIST INJECTION	GADOXETATE DISODIUM	BAYER	1	S	Y	03-Jul-08
	022193	NAVSTEL	OPHTHALMIC SOLUTION; HYPROMELLOSE; DEXTROSE; GLUTATHIONE	ALCON	3	S	Y	24-Jul-08
	022276	NICARDIPINE HYDROCHLORIDE INJECTION	NICARDINE	TEVA PARENTERAL	5	S	Y	24-Jul-08
	022152	STAVZOR	VALPROIC ACID	BANNER	3	S	Y	29-Jul-08
	022156	CLEVIPREX	CLEVIDIPINE BUTYRATE	MEDICINES COMPANY	1	S	Y	01-Aug-08
	050817	CEFEPIME INJECTION	CEFEPIME INJECTION	BAXTER	3	S		05-Aug-08
	022186	AK-FLUOR	FLUORESCEIN INJECTION	AKORN	3	S		08-Aug-08
	022234*	DOCETAXEL INJECTION	DOCETAXEL INJECTION	HOSPIRA INC	5	S		11-Aug-08
	021894	XENAZINE	TETRABENAZINE	PRESTWICK	1	P,O	Y	15-Aug-08
	022233	ALOXI	PALONOSETRAN HYDROCHLORIDE	HELSINN	3	S	Y	22-Aug-08
	021810	NOVOLOG MIX 50/50	BIPHASIC INSULIN ASPART 50/50	NOVO NORDISK	3	S	Y	26-Aug-08
	022198	SANCUSO	GRAINSETRON TRANSDERMAL SYSTEM/GRANISETR	STRAKAN	2	S	Y	12-Sep-08
	022285	KEPPRA EXTENDED RELEASE TABLETS	LEVETIRACETAM	UCB INC	3	S	Y	12-Sep-08
	022290	ADRE VIEW	IOBENUANE I 123 INJECTION	GE HEALTHCARE	1	P,O	Y	19-Sep-08
	*= DOCETAXEL INJECTION HAS BEEN TENTATIVELY APPROVED
●New Drug Application (NDA) Tentative Approvals
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	505(b)(2)	APPROVAL DATE
●New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	505(b)(2)	APPROVAL DATE
	021837	STAVUDINE; LAMIVUDINE; NEVIRAPINE	STAVUDINE; LAMIVUDINE; NEVIRAPINE	STRIDES	4	P		20-Mar-08
	022177	STAVUDINE; LAMIVUDINE; NEVIRAPINE	STAVUDINE; LAMIVUDINE; NEVIRAPINE	STRIDES	4	P	Y	20-Mar-08
	022167	LAMIVUDINE; STAVUDINE	LAMIVUDINE; STAVUDINE	CIPLA LIMITED	3	P	Y	19-Jun-08
	022141	TENOFAVIR DISOPROXYL FURMATE/LAMIVUDINE	TENOFAVIR DISOPROXYL FURMATE/LAMIVUDINE	MATRIX LABS	4	P	Y	12-Sep-08
	022293	ABACAVIR SULFATE	ABACAVIR SULFATE	AUROBINDO	3	P		12-Sep-08
	N021837 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR N022177 stavudine 30mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR. N022167 lamivudine 30mg/stavudine 6mg Tablets was tentatively approved on 06/19/2008 under PEPFAR. N022141 tenofavir disoproxyl furmate/lamivudine was tentatively approved on 09/12/2008 under PEPFAR. N022293 acacavir sulfate 60mg tablets was tentatively approved on 09/12/2008 under PEPFAR.

●BLA承認
ML	BLA Number	Proprietary Name	Proper Name	Applicant		RC	Approval Date
	125249	ARCALYST	RILONACEPT	REGENERON		P,O	27-Feb-08
	125160	CIMZIA	CERTOLIZUMAB PEGOL	UCB		S	22-Apr-08
	125196	PEGPAK	PEGINTERFERON; RIBAVIRIN	SCHERING		S	13-Jun-08
	125268	NPLATE	ROMIPLOSTIM	AMGEN		P	22-Aug-08
●Drugs and Biologic APPROVALS FOR CALENDAR YEAR 2007
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
	N022013	Olux-E	clobetasol propionate	Connetics	5	S	12-Jan-2007
	N022000	Lialda	mesalamine	Shire	3	S	16-Jan-2007
	N021234	Flector	diclofenac epolamine	INST Biochem	2	S	31-Jan-2007
	N021777	Amrix	cyclobenzaprine hydrochloride	ECR Pharms	3	S	01-Feb-2007
	N021887	Alli	orlistat	GlaxoSmithKline	8	S	07-Feb-2007
	N021977	Vyvanse	lisdexamfetamine dimesylate	New River	1	S	23-Feb-2007
	N022021	Altace	ramipril	Cobalt	3	S	27-Feb-2007
	N021985	Tekturna	aliskiren	Novartis	1	S	05-Mar-2007
	N022059	Tykerb	lapatinib	GlaxoSmithKline	1	P	13-Mar-2007
	N022044	Janumet	sitagliptin/metformin hydrochloride	Merck	4	S	30-Mar-2007
	N022055	Altabax	retapamulin	GlaxoSmithKline	1	S	12-Apr-2007
	N021817	Reclast	zoledronic acid	Novartis	3	P	16-Apr-2007
	N021905	Valtropin	somatropin	Parexel	5	S	19-Apr-2007
	N021412	Zolpidem Tartrate	zolpidem tartrate	Biovail	3	S	25-Apr-2007*
	N022051	Veramyst	fluticasone furoate	GlaxoSmithKline	2	S	27-Apr-2007
	N022007	Perforomist	formoterol fumarate dehydrate	Dey	3	S	27-Apr-2007*
	N050810	Azasite	azithromycin	InSite Vision	3	S	27-Apr-2007
	N022058	Supprelin LA	histrelin acetate	Indevus	5	S,O	03-May-2007
	N021829	Neupro	rotigotine	Schwarz BioSciences	1	S	09-May-2007
	N022047	Seroquel XR	quetiapine fumarate	AstraZeneca	3	S	17-May-2007
	N022076	Locoid	hydrocortisone butyrate	Ferndale	3	S	18-May-2007
	N021864	Lybrel	levonorgestrel and ethinyl estradiol	Wyeth	5	S	22-May-2007
	N022064	Xyzal	levocetirizine dihydrochloride	UCB	5	S	25-May-2007
	N022088	Torisel	temsirolimus	Wyeth	1	P,O	30-May-2007
	N022052	Zyflo CR	zileuton	Critical Therapeutics	3	S	30-May-2007
	N022038	Divigel	estradiol	Upsher-Smith	5	S	04-Jun-2007
	N021738	Extina	ketoconazole	Stiefel	3	S	12-Jun-2007
	N022116	Lexiva	fosamprenavir calcium	GlaxoSmithKline	3	P	14-Jun-2007
	N021875	Nuvigil	armodafinil	Cephalon	5	S	15-Jun-2007
	N022081	Letairis	ambrisentan	Gilead	1	P,O	15-Jun-2007
	N021753	Differin	adapalene	Galderma	3	S	19-Jun-2007
	N021990	Exforge	amlodipine;valsartan	Novartis	4	S	20-Jun-2007*
	N022057	Endometrin	progesterone	Ferring	3	S	21-Jun-2007
	N022083	Exelon	rivastigmine	Novartis	3	S	06-Jul-2007
	N021909	Allegra	fexofenadine hydrochloride	Sanofi Aventis	3	S	26-Jul-2007
	N022070	Atralin	tretinoin	Coria	3	S	26-Jul-2007
	N022014	Evamist	estradiol	Vivus	5	S	27-Jul-2007
	N022102	CaloMist	cyanocobalamin	Fleming	5	S	27-Jul-2007
	N022121	Tirosint	levothyroxine sodium	Institut Biochimique SA	3	S	01-Aug-2007
	N022103	Sanctura	trospium chloride	Indevus	3	S	03-Aug-2007
	N022128	Selzentry	maraviroc	Pfizer	1	P	06-Aug-2007
	N022118	Fenofibrate	fenofibrate	B & H Consulting	5	S	10-Aug-2007
	N022114	Zingo	lidocaine hydrochloride monohydrate	Anesiva	3	S	16-Aug-2007
	N022119	Ammonia	Ammonia	Feinstein	1	S	23-Aug-2007
	N022074	Somatuline Depot	lanreotide	Biomeasure	1	S,O	30-Aug-2007
	N022066	Omniscan	gadodiamide	GE Healthcare	5	S	05-Sep-2007
	N022025	Totect	dexrazoxane	Alba BioPharm	5	P	06-Sep-2007
	N022137	Fludarabine Phosphate	fludarabine phosphate	Ebewe	3	S	21-Sep-2007
	N022100	Azor	amlodipine;olmesartan medoxomil	Daiichi Sankyo	4	S	26-Sep-2007
	N022026	Amlodipine	amlodipine	Synthon	3	S	27-Sep-2007
	N022071	Lamisil	terbinafine hydrochloride	Novartis	3	S	28-Sep-2007
	N021961	Simvastatin	simvastatin	Synthon	3	S	09-Oct-2007
	N020981	Hycamtin	topotecan	GlaxoSmithKline	3	P	11-Oct-2007
	N022106	Doribax	doripenem	Johnson & Johnson	1	S	12-Oct-2007
	N022145	Isentress	raltegravir potassium	Merck	1	P	12-Oct-2007
	N022065	Ixempra	ixabepilone	Bristol-Myers Squibb	1	P	16-Oct-2007
	N022122	Voltaren	diclofenac sodium	Novartis	3	S	17-Oct-2007
	N022127	Renvela	sevelamer carbonate	Genzyme	3	S	19-Oct-2007
	N022068	Tasigna	nilotinib	Novartis	1	S,O	29-Oct-2007
	N021398	Combigan	brimonidine tartrate/timolol maleate	Allergan	4	S	30-Oct-2007
	N022020	Protonix	pantoprazole sodium	Wyeth	3	S	14-Nov-2007
	N022155	Zyrtec	certirizine hydrochloride	Pfizer	8	S	16-Nov-2007
	N022048	Triesence	triamcinolone acetonide	Alcon	3	P	29-Nov-2007
	N022032	omeprazole	omeprazole	Lachman Consultant Services	5	S	04-Dec-2007*
	N022181	Kuvan	sapropterin dihydrochloride	BioMarin	1	P,O	13-Dec-2007
	N021742	Bystolic	nebivolol	Mylan Bertek	1	S	17-Dec-2007
	N021519	Luvox	fluvoxamine maleate	Solvay	3	S	20-Dec-2007
	N022152	Stavzor	valproic acid	Banner	3	S	21-Dec-2007*
	* N021412 Zolpidem Tartrate was tentatively approved on 09/21/2006. * N022007 Perforomist was tentatively approved on 04/27/2007. * N022032 Omeprazole was tentatively approved on 06/14/2007. * N021990 Exforge was tentatively approved on 12/21/2006. * N022152 Stavzor was tentatively approved on 12/21/2007.
●New Drug Application (NDA) Tentative Approvals
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
●New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
	N021974	lamivudine;stavudine	lamivudine;stavudine	Cipla Limited	4	P	19-Jan-2007
	N021939	lamivudine;zidovudine; nevirapine	lamivudine;zidovudine;nevirapine	Aurobindo	4	P	29-Jan-2007
	N021971	lamivudine;stavudine; nevirapine	lamivudine;stavudine;nevirapine	Cipla Limited	4	P	31-Jan-2007
	N021988	lamivudine;zidovudine; nevirapine	lamivudine;zidovudine;nevirapine	Strides Arcolab Limited	4	P	02-Mar-2007
	N021838	stavudine;lamivudine	stavudine;lamivudine	Strides Arcolab Limited	4	P	13-Mar-2007
	N021854	stavudine;lamivudine; nevirapine	stavudine;lamivudine;nevirapine	Strides Arcolab Limited	4	P	13-Mar-2007
	N022096	lamivudine;zidovudine; efavirenz	lamivudine;zidovudine;efavirenz	Strides Arcolab Limited	3	P	01-Jun-2007
	N022097	lamivudine;stavidine; efavirenz	lamivudine;stavidine;efavirenz	Strides Arcolab Limited	3	P	01-Jun-2007
	N021972	lamivudine;stavudine; nevirapine	lamivudine;stavudine;nevirapine	Cipla Limited	3,4	P	13-Aug-2007
	N022085	lamivudine;stavudine	lamivudine;stavudine	Matrix	4	P	02-Nov-2007
	N021974 lamivudine 150mg/stavudine 30mg and  lamivudine 150mg/stavudine 40mg Tablets was tentatively approved on 01/19/2007 under PEPFAR. N021971 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 01/31/2007 under PEPFAR. N021988 lamivudine 300mg/zidovudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/02/2007 under PEPFAR. N021838 stavudine 40mg/lamivudine 150mg Tablets was tentatively approved on 03/13/2007 under PEPFAR. N021854 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/13/2007 under PEPFAR. N022096 lamivudine 150mg/zidovudine 300mg/efavirenze 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR. N022097 lamivudine 150mg/stavidine 40mg/efavirenze 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR. N021972 lamivudine 30mg/stavudine 6mg/nevirapine 50mg Tablets was tentatively approved on 08/13/2007 under PEPFAR. N022145 Isentress 400 mg Tablets was approved on 10/12/2007 under PEPFAR. N022085 lamivudine 150mg/stavidine 30mg Tablets was tentatively approved on 11/02/2007 under PEPFAR.
●BLA承認
ML	BLA Number	Proprietary Name	Proper Name	Applicant		RC	Approval Date
	BL125166	Soliris	eculizumab	Alexion		P,O	16-Mar-2007
	BL125164	Mircera	methoxy polyethylene glycol-epoetin beta	Hoffman-La Roche		S	14-Nov-2007
●Drugs and Biologic APPROVALS FOR CALENDAR YEAR 2006
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
	N021858	Boniva	ibandronate sodium	Hoffmann-La Roche	3	S	06-Jan-2006
	N021852	Taclonex	calcipotriene; betamethasone dipropionate	LEO Pharma	3	S	09-Jan-2006
	N021612	Lipofen	fenofibrate	Cipher	3	S	11-Jan-2006
	N021812	Men's Rogaine	minoxidil	Pharmacia and Upjohn	3	S	20-Jan-2006
	N021938	Sutent	sunitinib malate	Pfizer	1	P	26-Jan-2006
	N021247	Aerospan	flunisolide HFA	Forest Labs	3	S	27-Jan-2006
	N021526	Ranexa	ranolazine	CV Therapeutics	1	S	27-Jan-2006
	N021868	Exubera	insulin [rDNA Origin]	Pfizer	3	S	27-Jan-2006
	N021908	Amitiza	lubiprostone	Sucampo	1	S	31-Jan-2006
	N021313	Clarinex-D 12 Hour	desloratadine; pseudoephedrine sulfate	Schering	5	S	01-Feb-2006
	N021026	Vusion	miconazole nitrate	Barrier Therapeutics	3	S	16-Feb-2006
	N021920	naproxen sodium	naproxen sodium	Banner Pharmacaps	3	S	17-Feb-2006
	N021871	Loestrin 24 Fe	norethindrone acetate; ethinyl estradiol; ferrous fumarate	Warner Chilcott	3	S	17-Feb-2006
	N021632	Eraxis	anidulafungin	Vicuron	1	S	17-Feb-2006
	N021849	Zegerid	omeprazole; sodium bicarbonate	Santarus	4	S	27-Feb-2006
	N021336	Emsam	selegiline hydrochloride	Somerset Pharms	3	S	27-Feb-2006
	N021676	YAZ	drospirenone; ethinyl estradiol	Berlex	2	S	16-Mar-2006
	N021892	OsmoPrep	sodium phosphate monobasic monohydrate; sodium phosphate dibasic anhydrous	Salix	3	S	16-Mar-2006
	N021850	Zegerid with Magnesium Hydroxide	magnesium hydroxide; omeprazole; sodium bicarbonate	Santarus	3,4	S	24-Mar-2006
	N021980	Fluorescite	fluorescein	Alcon Research	5	P	28-Mar-2006
	N021483	Geodon	ziprasidone hydrochloride	Pfizer	3	S	29-Mar-2006
	N022010	Septocaine	articaine hydrochloride; epinephrine	Deproco	5	S	30-Mar-2006
	N021514	Daytrana	methylphenidate	Noven Pharms	2,3	S	06-Apr-2006
	N021897	Vivitrol	naltrexone	Alkermes	3	P	13-Apr-2006
	N021903	NeoProfen	ibuprofen lysine	Farmacon-IL, LLC	2	P, O	13-Apr-2006
	N021790	Dacogen	decitabine	MGI Pharma	1	S, O	02-May-2006
	N050808	Solodyn	minocycline hydrochloride	Medicis	3	S	08-May-2006
	N021928	Chantix	varenicline	Pfizer	1	P	10-May-2006
	N021641	Azilect	rasagiline mesylate	TEVA	1	S	16-May-2006
	N021860	Sarafem	fluoxetine hydrochloride	Warner Chilcott	3	S	19-May-2006
	N021338	Ionsys	fentanyl iontophoretic transdermal system	ALZA	3	S	22-May-2006
	N021764	brimonidine tartrate	brimonidine tartrate	Alcon	5	S	22-May-2006
	N021840	Seasonique	levonorgestrel/ethinyl estradiol and ethinyl estradiol	Duramed	3	S	25-May-2006
	N050805	Oracea	doxycycline	CollaGenex	3	S	26-May-2006
	N021426	Omnitrope	somatropin [rDNA origin]	Sandoz	5	S	30-May-2006
	N021959	Orapred ODT	prednisolone sodium phosphate	BioMarin	3	S	01-Jun-2006
	N021729	Abilify Discmelt	Aripiprazole	Otsuka	3	S	07-Jun-2006
	N021254	Advair HFA	Fluticasone propionate and salmeterol xinafoate	GlaxoSmithKline	3	S	08-Jun-2006
	N021479	Zelapar	selegiline hydrochloride	Valeant	3	S	14-Jun-2006
	N021610	Opana	oxymorphone hydrochloride	Endo	3	S	22-Jun-2006
	N021611	Opana	oxymorphone hydrochloride	Endo	3	S	22-Jun-2006
	N021976	Prezista	darunavir	Tibotec	1	P	23-Jun-2006
	N021986	Sprycel	dasatinib	Bristol-Myers Squibb	1	P, O	28-Jun-2006
	N021717	lidocaine; tetracaine	lidocaine; tetracaine	Zars	4	S	29-Jun-2006
	N021937	Atripla	efavirenz; emtricitabine; tenofovir disoproxil fumarate	Gilead Sciences	4	P	12-Jul-2006
	N021949	budesonide	budesonide	AstraZeneca	5	S	12-Jul-2006
	N021529	Implanon	etonogestrel	Organon USA	3	S	17-Jul-2006
	N021502	Anthelios SX	avobenzone; ecamsule; octocrylene	L'Oreal	1,4	S	21-Jul-2006
	N021929	Symbicort	budesonide; formoterol fumarate dihydrate	AstraZeneca	4	S	21-Jul-2006
	N021958	Lamisil AT	terbinafine	Novartis	8	S	24-Jul-2006
	N021910	Normocarb HF	sodium chloride; magnesium chloride hexahydrate; sodium bicarbonate	Dialysis Solutions	3	S	26-Jul-2006
	N021925	Duetact	pioglitazone hydrochloride;glimepiride	Takeda Global	4	S	28-Jul-2006
	N021946	Xolegel	ketoconazole	Barrier Therapeutics	3	S	28-Jul-2006
	N021872	Keppra	levetiracetam	UCB	3	S	31-Jul-2006
	N021881	Moviprep	PEG 3350; sodium sulfate; sodium chloride; potassium chloride; sodium ascorbate; ascorbic acid	Norgine	3	S	02-Aug-2006
	N021891	Children's Claritin	loratadine	Schering-Plough	3	S	23-Aug-2006
	N021956	Dutoprol	metoprolol succinate; hydrochlorothiazide	AstraZeneca	4	S	28-Aug-2006
	N022003	Noxafil	posaconazole	Schering	1	P	15-Sep-2006
	N050807	epirubicin hydrochloride	epirubicin hydrochloride	Mayne	5	S	15-Sep-2006
	N021978	Verdeso	desonide	Connetics	3	S	19-Sep-2006
	N021866	Abilify	aripiprazole	Otsuka Maryland Research	3	S	20-Sep-2006
	N021412	zolpidem tartrate	zolpidem tartrate	Biovail	3	S	21-Sep-2006
	N021994	Travatan Z	travoprost	Alcon	3	S	21-Sep-2006
	N021947	Fentora	fentanyl buccal	Cephalon	3	S	25-Sep-2006
	N021983	Duodote	atropine;pralidoxime chloride	Meidian	5	P	28-Sep-2006
	N050786	Pylera	biskalcitrate;metronidazole;tetracycline hydrochloride	Axcan Scandipharm	1,4	S	28-Sep-2006
	N021586	Duraprep	iodine;isopropyl alcohol	3M Health	4	S	29-Sep-2006
	N021501	Capital Soleil 15; UV Expert 15	avobenzone;ecamsule;octocrylene	L'Oreal	5	S	02-Oct-2006
	N021471	UV Protective Suncare; Capitol Soleil 20; Anthelios 20; UV Expert 20	avobenzone;ecamsule;octocrylene;titanium dioxide	L'Oreal	4	S	05-Oct-2006
	N022015	Miralax	polyethylene glycol 3350	Braintree	8	S	06-Oct-2006
	N021991	Zolinza	vorinostat	Merck	1	P,O	06-Oct-2006
	N021912	Brovana	arformoterol tartrate	Sepracor	3	S	06-Oct-2006
	N021924	Tirosint	levothyroxine sodium	Institute Biochimique SA (IBSA)	3	S	13-Oct-2006
	N021995	Januvia	sitagliptin phosphate	Merck	1	S	16-Oct-2006
	N021963	Allegra	fexofenadine hydrochloride	Sanofi Aventis	3	S	16-Oct-2006
	N022012	Coreg CR	carvedilol phosphate	GlaxoSmithKline	2	S	20-Oct-2006
	N022004	Omnaris	ciclesonide	Altana	1	S	20-Oct-2006
	N021957	Nexium	esomeprazole magnesium	AstraZeneca	3	S	20-Oct-2006
	N021844	Desonate	desonide	Dow Pharmaceutical Sciences	3	S	20-Oct-2006
	N022011	Tyzeka	telbivudine	Idenix	1	S	25-Oct-2006
	N021703	Prismasol	sodium bicarbonate;sodium chloride;potassium chloride;magnesium chloride;lactic acid;dextrose;calcium chloride	Gambro Renal Products	3	S	25-Oct-2006
	N021902	Veregen	kunecatechins	MediGene	1	S	31-Oct-2006
	N021780	NitroMist	nitroglycerin	NovaDel	3	S	02-Nov-2006
	N050802	Ziana	clindamycin phosphate;tretinoin	Dow Pharmaceutical Sciences	4	S	07-Nov-2006
	N021996	Alaway	ketotifen fumarate	Alimera Sciences	3	S	01-Dec-2006
	N021993	Claritin RediTabs	loratadine	Schering-Plough	5	S	12-Dec-2006
	N021592	Foradil Certihaler	formoterol fumarate	Novartis	3	S	15-Dec-2006
	N021813	Elestrin	estradiol	BioSante	5	S	15-Dec-2006
	N022041	Cyanokit	hydroxocobalamin	EMD Pharm	3	P,O	15-Dec-2006
	N021999	Invega	paliperidone	Janssen, L.P.	1	S	19-Dec-2006
	N050809	Azithromycin	azithromycin	Sicor	3	S	19-Dec-2006
	N021915	Ondansetron	ondansetron sodium chloride	Baxter Healthcare	3	S	27-Dec-2006
	N021612 Liopofen was tentatively approved on 7/15/2004 N021764 Brimonidine Tartrate was tentatively approved on 2/28/2005  N050807 Epirubicin was tentatively approved on 8/17/2006 N021915 Ondansetron was tentatively approved on 5/26/2006
●New Drug Application (NDA) Tentative Approvals
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
	N021714	amlodipine maleate;benazepril hydrochloride	amlodipine maleate;benazepril hydrochloride	Reddy's Lab	4	S	15-Sep-2006
	N021990	Exforge	amlodipine besylate	Novartis	4	S	21-Dec-2006
	N021714 amlodipine maleate;benazepril hydrochloride was tentatively approved on 9/15/2006 N021990 Exforge was tentatively approved on 12/21/2006
●New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
	N021943	efavirenz; lamivudine; zidovudine	efavirenz; lamivudine; zidovudine	Aurbindo	4	P	06-Mar-06
	N021939	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Aurobindo	4	P	30-Jun-2006
	N021944	lamivudine; zidovudine; abacavir sulfate	abacavir sulfate; lamivudine; zidovudine	Aurobindo	4	P	26-Jul-2006
	N022018	lamivudine; zidovudine;	lamivudine; zidovudine;	Pharmacare	4	P	23-Aug-2006
	N021969	lamivudine;stavudine;nevirapine lamivudine;stavudine;nevirapine	Cipla Limited	4	P	17-Nov-2006
	N021943 lamivudine 150mg/zidovudine 300mg Fixed-Dose Tablets co-packaged with efavirenz 600mg Tablets was tentatively approved on 3/06/2006 under PEPFAR. N021939 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 6/30/2006 under PEPFAR. N021944 lamivudine 150mg/zidovudine 300mg/Copackaged with abacavir sulfate 300mg Tablets was tentatively approved on 07/26/2006 under PEPFAR. N022018 lamivudine 150mg/zidovudine 300mg Tablets was tentatively approved on 08/23/2006 under PEPFAR. N021969 lamivudine 150mg/stavudine 30mg/nevirapine 200mg and lamivudine 150mg/stavudine 40mg/nevirapine 200mg Tablets was tentatively approved on 11/17/2006 under PEPFAR.
●BLA承認
ML	BLA Number	Proprietary Name	Proper Name	Applicant		RC	Approval Date
	BL125141	Myozyme	alglucosidase alfa	Genzyme		P, O	28-Apr-2006
	BL125156	Lucentis	ranibizumab	Genentech		P	30-Jun-2006
	BL125151	Elaprase	idursulfase	Shire Human Genetic Therapies		P, O	24-Jul-2006
	BL125147	Vectibix	panitumumab	Amgen		P	27-Sep-2006
●Drugs and Biologic APPROVALS FOR CALENDAR YEAR 2005
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
1208	N021660	Abraxane	Paclitaxel Protein-Bound Particles	American BioScience	5	S	07-Jan-05
	N021726	Niravam	Alprazolam	Schwarz Pharma	5	S	19-Jan-05
配	N021841	Lamivudine; Zidovudine; Nevirapine	Lamivudine; Zidovudine; Nevirapine	Pharmacare	4	P	24-Jan-05*
	N021642	Nascobal	Cyanocobalamin	Nastech Pharma	3	S	31-Jan-05
	N021759	Eloxatin	Oxaliplatin	Sanofi-Synthelabo	5	S	31-Jan-05
	N021758	Vanos	Fluocinonide	Medicis Pharma	3	S	11-Feb-05
	N020645	Ammonul	Sodium Benzoate; Sodium Phenylacetate	Ucyclyd Pharma	5	P, O	17-Feb-05
	N021269	Cardura XL	Doxazosin Mesylate	Pfizer	3	S	22-Feb-05
	N021764	Brimonidine Tartrate	Brimonidine Tartrate	Alcon	3	S	28-Feb-05*
	N021605	Clarinex D24	Desloratadine; Pseudoephedrine Sulfate	Schering	3	S	03-Mar-05
	N021730	Xopenex HFA	Levalbuterol Tartrate	Sepracor	3	S	11-Mar-05
	N021332	Symlin	Pramlintide Acetate	Amylin	1	S	16-Mar-05
1211	N021506	Mycamine	Micafungin Sodium	Fujisawa	1	P	16-Mar-05
	N021664	Xibrom	Bromfenac Sodium	ISTA Pharms	3	S	24-Mar-05
	N021584	Depo-SubQ Provera 104	Medroxyprogesterone Acetate	Pfizer	5	S	25-Mar-05
1210	N021797	Baraclude	Entecavir	Bristol Myers Squibb	1	P	29-Mar-05
1210	N021798	Baraclude	Entecavir	Bristol Myers Squibb	3	P	29-Mar-05
	N021067	Asmanex Twisthaler	Mometasone Furoate	Schering	3	S	30-Mar-05
	N021152	Cutivate	Fluticasone Propionate	GlaxoSmithKline	3	S	31-Mar-05
	N021689	Nexium IV	Esomeprazole Sodium	AstraZeneca	3	S	31-Mar-05
配	N021762	Fosamax Plus D	Alendronate Sodium; Vitamin D3	Merck	4	S	07-Apr-05
	N021737	Retisert	Fluocinolone Acetonide	Bausch and Lomb	3	P, O	08-Apr-05
	N021627	Namenda	Memantine Hydrochloride	Forest Labs	3	S	18-Apr-05
	N050796	Ceftriaxone	Sodium; Dextrose in Duplex Container Ceftriaxone Sodium; Dextrose B	Braun	5	S	20-Apr-05
	N021669	Chlorhexidine Gluconate Cloth	Chlorhexidine Gluconate	Sage Prods	3	S	25-Apr-05
1210	N021773	Byetta	Exenatide	Amylin	1	S	28-Apr-05
	N021693	Tramadol Hydrochloride	Tramadol Hydrochloride	Biovail Labs	3	S	05-May-05
	N050795	Doryx	Doxycyclin Hyclate	Faulding Pharms	3	S	06-May-05
	N021350	Triglide	Fenofibrate	Skye Pharma	3	S	07-May-05
	N021744	Proquin XR	Ciprofloxacin Hydrochloride	Depomed	2	S	19-May-05
	N021806	Metronidazole	Metronidazole	Teva Pharms	5	S	20-May-05
	N021412	Zolpidem Tartrate	Zolpidem Tartrate	Biovail Labs	3	S	26-May-05*
	N021606	Zemplar	Paricalcitol	Abbott Labs	3	S	26-May-05
	N021802	Focalin XR	Dexmethylphenidate Hydrochloride	Novartis Pharms	3	S	26-May-05
配	N021524	Chlorascrub	Chlorhexidine Gluconate; Isopropyl Alcohol	Nice-Pak	3	S	03-Jun-05
	N021748	Glumetza	Metformin Hydrochloride	Biovail Labs	5	S	03-Jun-05
	N021845	Revatio	Sildenafil Citrate	Pfizer	5	P	03-Jun-05
	N021793	Metoclopramide	Metoclopramide	Schwarz Pharma	3	S	10-Jun-05
	N050797	Zmax	Azithromycin	Pfizer	3	S	10-Jun-05
	N021821	Tygacil	Tigecycline	Wyeth Pharms	1	P	15-Jun-05
	N021536	Levemir	Insulin Detemir	Novo Nordisk	1	S	16-Jun-05
	N021814	Aptivus	Tipranavir	Boehringer Ingelheim	1	P	22-Jun-05
配	N020727	Bidil	Hydralazine Hydrochloride; Isosorbide Dinitrate	Nitromed	4	S	23-Jun-05
配	N021623	Synera	Lidocaine; Tetracaine	Zars	4	S	23-Jun-05
	N021789	Metrogel	Metronidazole	Dow Pharm	3	S	30-Jun-05
	N021832	Levofloxacin	Levofloxacin	Sicor Pharms	3	S	30-Jun-05*
	N021778	Megace ES	Megestrol Acetate	Par Pharm	5	S	05-Jul-05
	N021794	Aczone	Dapsone	QLT USA	3	S	07-Jul-05
	N021782	Rozerem	Ramelteon	Takeda Global	1	S	22-Jul-05
	N021855	Loperamide Hydrochloride	Loperamide Hydrochloride	Banner Pharmacaps	3	S	4-Aug-05
配	N021823	Actonel With Calcium	Risedronate Sodium; Calcium Carbonate	Proctor and Gamble	4	S	12-Aug-05
	N021799	Quinine Sulfate	Quinine Sulfate	Mutual	5	S	12-Aug-05
	N021406	Fortical	Calcitonin-Salmon (rDNA origin)	Unigene	3	S	12-Aug-05
	N021862	Nevanac	Nepafenac	Alcon	1	P	19-Aug-05
	N021770	Alphagan P	Brimonidine Tartrate	Allergan	3	S	19-Aug-05
	N021273	Follistim AQ	Follitropin Beta	Organon	3	S	26-Aug-05
配	N021842	Actoplus Met	Metformin Hydrochloride; Pioglitazone Hydrochloride	Takeda	4	S	29-Aug-05
	N021839	Increlex	Mecasermin (rDNA origin)	Tercica	1	P, O	30-Aug-05
	N021774	Ambien CR	Zolpidem Tartrate	Sanofi Synthelabo	3	S	02-Sep-05
	N021692	Tramadol Hydrochloride	Tramadol Hydrochloride	Biovail	5	S	08-Sep-05
	N021355	Angeliq	Drospirenone; 17B-Estradiol	Berlex	4	S	28-Sep-05
	N021896	Emtriva	Emtricitabine	Gilead	3	P	28-Sep-05
	N021734	Loratadine	Loratadine	Taro Pharm	3	S	04-Oct-05
	N021716	Hydase	Hyaluronidase	PrimaPharm	1	P	25-Oct-05
	N021835	Clobex	Clobetasol Propionate	Dow Pharm	3	S	27-Oct-05
	N021877	Arranon	Nelarabine	GlaxoSmithKline	1	P, O	28-Oct-05
	N021906	Kaletra	Lopinavir; Ritonavir	Abbott Labs	3	P	28-Oct-05
	N021807	Soltamox	Tamoxifen Citrate	Savient Pharms	3	S	29-Oct-05
	N021882	Exjade	Deferasirox	Novartis	1	P, O	02-Nov-05
	N021700	Avandaryl	Rosiglitazone Maleate; Glimepride	SB Pharmco	4	S	23-Nov-05
	N021859	Hylenex	Recombinant Hyaluronidase	Human Halozyme	1	P	02-Dec-05
	N021884	Iplex	Mecasermin Rinfabate [rDNA Origin]	Insmed	1, 4	P, O	12-Dec-05
	N021763	Citalopram Hydrobromide	Citalopram Hydrobromide	Biovail	3	S	20-Dec-05
	N021923	Nexavar	Sorafenib Tosylate	Bayer	1	P, O	20-Dec-05
	N021393	Advil PM Liqui-Gels	Ibuprofen; Diphenhydramine Citrate	Wyeth	4	S	21-Dec-05
	N021394	Advil PM Caplets	Ibuprofen; Diphenhydramine Citrate	Wyeth	4	S	21-Dec-05
	N021880	Revlimid	Lenalidomide	Celgene	1	P, O	27-Dec-05
	N021697	Vaprisol	Conivaptan Hydrochloride	Astellas	1	S	29-Dec-05
●BLA承認
ML	BLA Number	Proprietary Name	Proper Name	Applicant		RC	Approval Date
	BL125117	Naglazyme	Galsulfase	Biomarin Pharmaceutical Inc.		P, O	31-May-05
1229	BL125118	Orencia	Abatacept	Bristol-Myers Squibb	P	23-Dec-05
●Drugs and Biologic APPROVALS FOR CALENDAR YEAR 2004
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
	N021604	Children's Elixsure IB	Ibuprofen	Taro Pharms	5	S	07-Jan-04
	N021539	Acetadote	Acetylcysteine	Cumberland Pharms	3	P, O	23-Jan-04
	N021646	Infuvite Pediatric	Multiple Vitamins	Sabex 2002	5	S	29-Jan-04
1183	N021395	Spiriva Handihaler	Tiotropium Bromide	Boehringer Ingelheim	1	S	30-Jan-04
1186 配	N021540	Caduet	Amlodipine Besylate; Atorvastatin Calcium	Pfizer	4	S	30-Jan-04
	N021625	MVI Adult	Multi-Vitamins	aaiPharma	3	S	30-Jan-04
1180	N021462	Alimta	Pemetrexed Disodium	Eli Lilly	1	P, O	04-Feb-04
	N021594	Amiodarone Hydrochloride	Amiodarone Hydrochloride	International Medication Sys	5	S	04-Feb-04
	N021644	Clobex	Clobetasol Propionate	Galderma Labs	3	S	05-Feb-04
	N021166	Estrogel	Estradiol	Solvay Pharms	3	S	09-Feb-04
	N021590	Fazaclo	Clozapine	Alamo Pharms	3	S	10-Feb-04
配	N021643	MVI Adult	Multi-Vitamins	aaiPharma	3	S	18-Feb-04
配	N021587	Children's Advil Allergy Sinus	Ibuprofen; Pseudophedrine Hydrochloride; Chlorpheniramine Maleate	Wyeth Cons	3	S	24-Feb-04
	N050791	Myfortic	Mycophenolic Acid	Novartis Pharms	2	S	27-Feb-04
	N021571	Iquix	Levofloxacin	Santen	3	S	01-Mar-04
1192	N021688	Sensipar	Cinacalcet Hydrochloride	Amgen	1	P, O	08-Mar-04
	N021621	Zyrtec	Cetirizine Hydrochloride	Pfizer	3	S	16-Mar-04
	N021211	Follistim AQ	Follitropin Beta	Organon	3	S	23-Mar-04
	N021765	Gonal-F	Follitropin Alfa	Serono Inc	3	S	25-Mar-04
	N021253	Zyprexa IM	Olanzapine	Eli Lilly	3	S	29-Mar-04
1189	N021144	Ketek	Telithromycin	Aventis Pharms	1	S	01-Apr-04
	N020784	Nasacort HFA	Triamcinolone Acetonide	Aventis Pharms	3	S	07-Apr-04
	N021256	ChiRhoStim	Human Secretin	Chirhoclin	1	P	09-Apr-04
	N021629	Apidra	Insulin Glulisine	Aventis Pharms	1	S	16-Apr-04
1200	N021264	Apokyn	Apomorphine Hydrochloride	Bertek	1	P, O	20-Apr-04
	N021574	Fortamet	Metformin Hydrochloride	Andrx	5	S	27-Apr-04
	N021640	Vitrase	Ovine Hyaluronidase	Ista Pharms	1	P	05-May-04
	N021504	Lidosite Topical System	Lidocaine Hydrochloride; Epinephrine	Vyteris	3	S	06-May-04
	N021617	Zalkote	Valproate Sodium	Andrx	3	S	06-May-04*
	N021443	Enjuvia	Synthetic Conjugated Estrogens, B	Duramed	3	S	10-May-04
配	N021551	Halflytely and Bisacodyl Bowel Prep Kit	PEG-3350; Sodium Chloride; Sodium Bicarbonate; Potassium Chloride; Bisacodyl	Braintree	3	S	10-May-04
	N021433	Flovent HFA	Fluticasone Propionate	GlaxoSmithKline	3	S	14-May-04
1190	N021618	Tindamax	Tinidazole	Presutti Labs	1	S	17-May-04
	N021671	Depodur	Morphine Sulfate	Skye Pharma	3	S	18-May-04
1201	N050794	Vidaza	Azacitidine	Pharmion	1	P, O	19-May-04
1191	N021361	Xifaxan	Rifaximin	Salix Pharms	1	S	25-May-04
	N021494	Axid	Nizatidine	Reliant Pharma	3	S	25-May-04
	N021684	Gonal-F RFF Pen	Follitropin Alfa	Serono Inc	3	S	25-May-04
	N021566	Prevacid IV	Lansoprazole	Tap Pharm	3	S	27-May-04
1188	N021595	Sanctura	Trospium Chloride	Indevus	1	S	28-May-04
	N021530	Mobic	Meloxicam	Boehringer Ingelheim	3	S	01-Jun-04
	N021516	Istalol	Timolol Maleate	Senju	3	S	04-Jun-04
	N021667	NutreSore	L-Glutamine	Nutritional Restart	1	S, O	10-Jun-04
1206	N021636	Zegerid	Omeprazole	Santarus	3	S	15-Jun-04
配	N021369	Codeprex	Codeine Polistirex; Chlorpheniramine Polistirex	Celltech Pharms	3	S	21-Jun-04
配	N021585	Mucinex D	Guaifenesin; Pseudoephedrine Hydrochloride	Adams	3	S	22-Jun-04
	N021512	Loratadine	Loratadine	Perrigo	3	S	24-Jun-04
	N050789	Tobramycin	Tobramycin	American Pharm	5	S	13-Jul-04
	N021612	Luxacor	Fenofibrate	Cipher	3	S	15-Jul-04*
	N021497	Alinia	Nitazoxanide	Romark	3	P	21-Jul-04
1191 配	N021687	Vytorin	Ezetimibe; Simvastatin	MSP Singapore	4	S	23-Jul-04
	N021415	Metvix	Methyl Aminolevulinate	PhotoCure ASA	3	S	27-Jul-04
1199	N021431	Campral	Acamprosate Calcium	Lipha	1	P	29-Jul-04
	N050792	Cefotaxime and Dextrose Duplex Container	Cefotaxime Sodium	B Braun	5	S	29-Jul-04
1203 配	N021652	Epzicom	Abacavir Sulfate; Lamivudine	GlaxoSmithKline	3	S	02-Aug-04
1203 配	N021752	Truvada	Emtricitabine; Tenofovir Disoproxil Fumarate	Gilead Sciences	4	P	02-Aug-04
1193	N021427	Cymbalta	Duloxetine Hydrochloride	Eli Lilly	1	S	03-Aug-04
	N021768	Fludeoxyglucose F18	Fludeoxyglucose F18	Weill Medical College	3	S	05-Aug-04
	N021749	Pentetate Calcium	Trisodium Pentetate Calcium Trisodium	Pharma Hameln GmbH	1	P, O	11-Aug-04
	N021751	Pentetate Zinc Trisodium	Pentetate Zinc Trisodium	Pharma Hameln GmbH	1	P, O	11-Aug-04
	N021633	Femtrace	Estradiol Acetate	Warner Chilcott	3	S	20-Aug-04
	N021648	Digoxin	Digoxin	Roxane	7	S	26-Aug-04
	N021678	Tequin	Gatifloxacin	Bristol-Myers Squibb	3	S	27-Aug-04
	N021698	Zantac	Ranitidine Hydrochloride	Pfizer Consumer Healthcare	3	S	31-Aug-04
	N021300	Clarinex	Desloratadine	Schering	3	S	01-Sep-04
	N021563	Clarinex	Desloratadine	Schering	3	P	01-Sep-04
	N021712	Fluxid	Famotidine	Schwarz Pharma	3	S	24-Sep-04
1204	N021044	Palladone	Hydromorphone Hydrochloride	Purdue Pharma	3	S	24-Sep-04
	N021727	Amlexanox	Amlexanox	Access Pharms	3	S	29-Sep-04
	N021735	Terconazole	Terconazole	Altana	5	S	01-Oct-04
	N021322	Luveris	Lutropin Alfa	Serono Inc	3	S,O	08-Oct-04
	N021732	Vantas	Histrelin Acetate	Valera	3	S	12-Oct-04
	N021683	Manoplex	Insoluble Prussian Blue	Degussa	5	P	14-Oct-04*
	N021719	Aricept	Donepezil Hydrochloride	EISAI Medical	3	S	18-Oct-04
	N021720	Aricept	Donepezil Hydrochloride	EISAI Medical	3	S	18-Oct-04
配	N021704	Allegra-D 24 Hour	Fexofenadine Hydrochloride; Pseudoephedrine Hydrochloride	Aventis Pharms	3	S	19-Oct-04
	N021721	Levaquin	Levoflaxin	Ortho McNeil	3	S	21-Oct-04
	N050801	Evoclin	Clindamycin Phosphate	Connetics	3	S	22-Oct-04*
1228	N021468	Fosrenol	Lanthanum Carbonate Hydrate	Shire Pharm	1	S	26-Oct-04
配	N021486	Lidocaine Hydrochloride;Epinephrine	Lidocaine Hydrochloride; Epinephrine	EMPI	4	S	26-Oct-04
	N021665	Amphadase	Hyaluronidase	Amphastar Pharm	1	P	26-Oct-04
	N021736	Xamlom	Amlodipine	Ranbaxy Res	3	S	28-Oct-04*
	N021457	Albuterol Sulfate	Albuterol Sulfate	Ivax Res	3	S	29-Oct-04
	N021663	Menopur	Menotropins	Ferring	3	S	29-Oct-04
	N021656	Tricor	Fenofibrate	Abbott	3	S	05-Nov-04
	N021654	Omacor	Omega-3-acid Ethyl Esters	Ross Prods	1	S	10-Nov-04
	N021527	Atrovent HFA	Ipratropium Bromide	Boehringer Ingelheim	3	S	17-Nov-04
1205	N021743	Tarceva	Erlotinib Hydrochloride	OSI Pharms	1	P	18-Nov-04
1204	N021518	VESIcare	Solifenacin Succinate	Yamanouchi	1	S	19-Nov-04
	N021357	Multihance	Gadobenate Dimeglumine	Bracco	1	S	23-Nov-04
	N021358	Multihance Multipack	Gadobenate Dimeglumine	Bracco	3	S	23-Nov-04
配	N021378	Combunox	Ibuprofen; Oxycodone Hydrochloride	Forest Labs	4	S	26-Nov-04
	N021695	Antara	Fenofibrate	Reliant Pharms	3	S	30-Nov-04
	N050793	Clindesse	Clindamycin Phosphate	KV Pharm	5	S	30-Nov-04
	N021786	Kelacal	Pentetate Calcium Trisodium	CIS	5	P	01-Dec-04*
	N021787	Kelazin	Pentetate Zinc Trisodium	CIS	5	P	01-Dec-04*
	N021713	Abilify	Aripiprazole	Otsuka America	3	S	10-Dec-04
	N021731	Eligard	Leuprolide Acetate	Atrix	3	S	14-Dec-04
配	N050804	Zylet	Loteprednol Etabonate; Tobramycin	Bausch and Lomb	4	S	14-Dec-04
1203	N021476	Lunesta	Eszopicline	Sepracor	1	S	15-Dec-04
	N021670	Vision Blue	Trypan Blue	Dorc International BV	1	P	16-Dec-04
	N021583	Depo-SubQ Provera 104	Medroxyprogesterone Acetate	Pfizer	3	S	17-Dec-04
1212	N021756	Macugen	Pegaptanib Sodium	Eyetech Pharms	1	P	17-Dec-04
	N021785	Invirase	Saquinavir Mesylate	Roche	3	P	17-Dec-04
	N021609	Enjuvia	Synthetic Conjugated Estrogens, B	Duramed Pharms	3	S	20-Dec-04
	N021706	Omeprazole	Omeprazole	Santarus	3	S	21-Dec-04
1204	N021513	Enablex	Darifenacin Hydrobromide	Novartis	1	S	22-Dec-04
	N021545	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Alcon	3	S	22-Dec-04
	N021615	Reminyl	Galantamine Hydrochloride	Johnson and Johnson	3	S	22-Dec-04
	N021060	Prialt	Ziconotide	Elan Pharms	1	P	28-Dec-04
	N021673	Clolar	Clofarabine	Genzyme	1	P, O	28-Dec-04
	N021779	Ventavis	Iloprost	Cotherix	1	P, O	29-Dec-04
	N021446	Lyrica	Pregabalin	Pfizer	1	P	30-Dec-04
●BLA承認
ML	BLA Number	Proprietary Name	Proper Name	Applicant		RC	Approval Date
	BL125084	Erbitux	Cetuximab	ImClone Systems		P	12-Feb-04
	BL125085	Avastin	Bevacizumab	Genentech		P	26-Feb-04
配	BL125083	Pegasys Copegus Combination Pack	Peginterferon alfa-2a co-packaged with Ribavirin	Hoffmann-La Roche		S	04-Jun-04
	BL103928	NeutroSpec	Technetium 99m Tc Fanolesomab	Palatin Technologies		S	02-Jul-04
1202 1204	BL125104	Tysabri	Natalizumab	Biogen Idec Inc.		P	23-Nov-04
1207	BL125103	Kepivance	Palifermin	Amgen, Inc.		P	15-Dec-04
●NDA APPROVALS FOR CALENDAR YEAR 2003
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	RC	APPROVAL DATE
1157	21434	Xanax XR	Alprazolam	Pharmacia and Upjohn FR	3	S	17-Jan-03
	21305	Sodium Iodide I-131	Sodium Iodide I-131	DraxImage	3,5	S	24-Jan-03
	20414	Pyridostigmine Bromide	Pyridostigmine Bromide	US Army	3	P	05-Feb-03
	21392	Cardizem LA	Diltiazem Hydrochloride	Biovail	3	S	06-Feb-03
	21488	Eligard	Leuprolide Acetate	Atrix	3	S	13-Feb-03
1156	21351	Oxytrol	Oxybutynin	Watson Labs (Utah)	3	S	26-Feb-03
	21159	Loprox	Ciclopirox	Medicis	3	S	28-Feb-03
	21438	InnoPran XL	Propranolol Hydrochloride	Reliant Pharms	5	S	12-Mar-03
1159	21481	Fuzeon	Enfuvirtide	Roche	1	P	13-Mar-03
	21367	Femring	Estradiol Acetate	Galen Ltd	2	S	20-Mar-03
1160	21106	Somavert	Pegvisomant	Pharmacia and Upjohn	1	PV	25-Mar-03
1162	21549	Emend	Aprepitant	Merck	1	P	26-Mar-03
1179	21493	Zymar	Gatifloxacin	Allergan	3	S	28-Mar-03
	21444	Risperdal	Risperidone	Johnson & Johnson	3	S	02-Apr-03
1192	21158	Factive	Gemifloxacin Mesylate	LG Life	1	S	04-Apr-03
	21271	Iprivask	Desirudin	Aventis Pharms	2	S	04-Apr-03
	21475	Methylin	Methylphenidate Hydrochloride	Mallinckrodt	3	S	15-Apr-03
1179	21598	Vigamox	Moxifloxacin Hydrochloride	Alcon	3	S	15-Apr-03
1106	21588	Gleevec	Imatinib Mesylate	Novartis	3	P	18-Apr-03
	21503	Viracept	Nelfinavir Mesylate	Agouron	3	S	30-Apr-03
1138	21399	Iressa	Gefitinib	AstraZeneca	1	P	05-May-03
1161	21602	Velcade	Bortezomib	Millennium Pharms	1	P	13-May-03
1207	21-455	Boniva	Ibandronate Sodium	Roche	1	S	16-May-03
配	21-496	Duocaine	Bupivacaine Hydrochloride; Lidocaine Hydrochloride	Amphastar Pharms	4	S	23-May-03
	20-800	Twinject	Epinephrine	Hollister-Stier Labs	3	S	30-May-03
	21-528	Acular LS	Ketorolac Tromethamine	Allergan	3	S	30-May-03
配	21-396	Prempro/Premphase	Conjugated Estrogens;Medroxyprogesterone Acetate	Wyeth Pharms	3	S	04-Jun-03
配	21-532	Benicar HCT	Olmesartan Medoxomil;Hydrochlorothiazide	Sankyo Pharma	4	S	05-Jun-03
	21-137	Levolet	Levothyroxine Sodium	Vintage Pharms	5	S	06-Jun-03
1182 配	21-485	Stalevo	Carbidopa;Levodopa;Entacapone	Orion	4	S	11-Jun-03
1173	21-287	Uroxatral	Alfuzosin Hydrochloride	Sanofi Synthelabo	1	S	12-Jun-03
	21-559	Infuvite Adult	Multiple Vitamins	Sabex	5	S	16-Jun-03
	21-543	Striant	Testosterone	Columbia Labs	3	S	19-Jun-03
	21-229	Prilosec	Omeprazole Magnesium	AstraZeneca LP	2,3	S	20-Jun-03
1169	21-567	Reyataz	Atazanavir Sulfate	Bristol Myers Squibb	1	P	20-Jun-03
配	21-387	Pravigard PAC	Aspirin;Pravastatin Sodium	Bristol Myers Squibb	4	S	24-Jun-03
1169	21500	Emtriva	Emtricitabine	Gilead	1	S	02-Jul-03
	21299	Paroxetine Mesylate	Paroxetine Mesylate	Synthon Pharms	2	S	03-Jul-03
	20452	Paraplatin	Carboplatin	Bristol Myers Squibb	3	S	14-Jul-03
	21505	Keppra	Levetiracetam	UCB	3	S	15-Jul-03
配	21537	Ciprodex	Ciprofloxacin;Dexamethasone	Alcon	3	S	18-Jul-03
	21535	Clobex	Clobetasol Propionate	Galderma Labs LP	3	S	24-Jul-03
1179	21372	Aloxi	Palonosetron Hydrochloride	Helsinn Hlthcare	1	S	25-Jul-03
	21546	Rebetol	Ribavirin	Schering	3	P	29-Jul-03
	21348	Zavesca	Miglustat	Actelion Pharms	1	SV	31-Jul-03
1167	21366	Crestor	Rosuvastatin Calcium	IPR	1	S	12-Aug-03
1166	21400	Levitra	Vardenafil Hydrochloride	Bayer	1	S	19-Aug-03
	21515	Wellbutrin XL	Bupropion Hydrochloride	GlaxoSmithKline	3	S	28-Aug-03
	21416	Rythmol SR	Propafenone Hydrochloride	Abbott	3	S	04-Sep-03
1175 配	21544	Seasonale	Ethinyl Estradiol;Levonorgesterol	Barr	3	S	05-Sep-03
	21591	Riomet	Metformin Hydrochloride	Ranbaxy	3	S	11-Sep-03
1175	21572	Cubicin	Daptomycin	Cubist Pharms	1	P	12-Sep-03
	21575	Fosamax	Alendronate Sodium	Merck	3	S	17-Sep-03
1174	21450	Zomig	Zolmitriptan	AstraZeneca	3	S	30-Sep-03
	21626	Radiogardase	Prussian Blue	Heyl Chemisch- pharmazeutische Fabrik GmbH	1	PV	02-Oct-03
	21371	Estrasorb	Estradiol	Novavax	3	S	09-Oct-03
	21489	ProHance	Gadoteridol	Bracco	3	S	09-Oct-03
	21487	Namenda	Memantine Hydrochloride	Forest Labs	1	S	16-Oct-03
	21565	Elestat	Epinastine Hydrochloride	Allergan	1	S	16-Oct-03
	21548	Lexiva	Fosamprenavir Calcium	GlaxoSmithKline	2	S	20-Oct-03
	21346	Risperdal Consta	Risperidone	Johnson and Johnson	3	S	29-Oct-03
	21589	Kemstro	Baclofen	Schwarz Pharma	3	S	30-Oct-03
	21435	Amvaz	Amlodipine Maleate	Dr Reddys Labs Inc	2	S	31-Oct-03
配	21490	Ovcon 35	Ethinyl Estradiol;Norethindrone	Warner Chilcott	3	S	14-Nov-03
配	21507	Prevacid;Naprapac	Lansoprozole;Naproxen	Tap Pharm	4	S	14-Nov-03
配	21258	Climara Pro	Estradiol;Levonorgestrel	Berlex Labs	4	S	21-Nov-03
1172	21368	Cialis	Tadalafil	Lilly Icos	1	S	21-Nov-03
1178	21320	Plenaxis	Abarelix	Praecis	1	P	25-Nov-03
1185	21385	Ertaczo	Sertaconazole Nitrate	Mylan Pharms	1	S	10-Dec-03
	21388	Sterile Talc Powder	Sterile Talc Powder	Bryan Corp	3	PV	15-Dec-03
配	21451	Oraqix	Lidocaine;Prilocaine	Dentsply Pharms	4	S	19-Dec-03
1135	21630	Vfend	Voriconazole	Pfizer Inc	3	S	19-Dec-03
1178 配	21520	Symbyax	Olanzapine;Fluoxetine Hydrochloride	Eli Lilly	4	P	24-Dec-03
●NDA APPROVALS FOR CALENDAR YEAR 2002
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	TC	APPROVAL DATE
配	21-175	ATNAA	Atropine;Pralidoxime Chloride	US Army	3	P	17-Jan-02
配	21-112	TRI-LUMA	Fluocinolone Acetonide;Hydroquinone;Tretinoin	Hill Dermaceuticals	4	S	18-Jan-02
	21-232	Orfadin	Nitisinone	Swedish Orphan	1	PV	18-Jan-02
	21-343	Eligard	Leuprolide Acetate	ATRIX	3	S	23-Jan-02
	21-360	Sustiva	Efavirenz	Bristol Myers Squibb	3	S	01-Feb-02
	21-342	Levo-T	Levothyroxine Sodium	Mova	5	S	01-Mar-02
	21-113	Pamidronate Disodium	Pamidronate Disodium	Bedford	5	S	04-Mar-02
	21-299	Asimia	Paroxetine Mesylate	Synthon Pharms	2	S	11-Mar-02
	21-260	Avinza	Morphine Sulfate	Elan Pharm	3	S	20-Mar-02
	20-855	Mesnex	Mesna	Bristol  Myers Squibb	3	S	21-Mar-02
	21-136	SecreFlo	Secretin	ChiRhoClin	3	SV	04-Apr-02
	21-209	SecreFlo	Secretin	ChiRhoClin	3*	PV	04-Apr-02
	21-310	Alora	Estradiol	Watson Labs	3	S	05-Apr-02
配	21-373	Children's Advil Cold	Ibuprofen;Pseudoephedrine HCl	Wyeth Consumer Healthcare	3	S	18-Apr-02
1136	21-286	Benicar	Olmesartan Medoxomil	Sankyo	1	S	25-Apr-02
1135	21-344	Faslodex	Fulvestrant	AstraZeneca	1	S	25-Apr-02
	21-289	Bravelle	Urofollitropin	Ferring	3	S	06-May-02
1139	21-272	Remodulin	Treprostinil Sodium	United Therapeutics	1	PV	21-May-02
1135	21-266	Vfend	Voriconazole	Pfizer	1	S	24-May-02
1135	21-267	Vfend	Voriconazole	Pfizer	3	S	24-May-02
	50784	Zithromax	Azithromycin Dihydrate	Pfizer	3	S	24-May-02
配	21-374	Advil Cold/Sinus	Ibuprofen;Pseudoephedrine HCl	Wyeth Consumer Healthcare	3	S	30-May-02
配	21-191	Imagent Kit for the Preparation of Perflexane Lipid Microspheres	Dimyristoylphosphatidylcholine; Perflexane	Alliance Pharm	1	S	31-May-02
	21-292	Novothyrox	Levothyroxine Sodium	Genpharm	5	S	31-May-02
	21-284	Ritalin LA	Methylphenidate HCl	Novartis Pharm	3	S	05-Jun-02
0958	21-212	Caverject	Alprostadil	Pharmacia & Upjohn	3	S	11-Jun-02
1106	20919	Geodon	Ziprasidone Mesylate	Pfizer	3	S	21-Jun-02
	21-312	Clarinex RediTabs	Desloratadine	Schering	3	S	26-Jun-02
1151	21-316	Altocor	Lovastatin	Aura Labs	3	S	26-Jun-02
	21-282	Mucinex	Guaifenesin	Adams Labs	3	S	12-Jul-02
1145	21-196	Xyrem	Sodium Oxybate	Orphan Medical	1	PV	17-Jul-02
1139	21-200	Zelnorm	Tegaserod Maleate	Novartis Pharms	1	P	24-Jul-02
*1132	21-379	Eligard	Leuprolide Acetate	Atrix	3	S	24-Jul-02
	21-402	Synthroid	Levothyroxine Sodium	Abbott Labs	5	S	24-Jul-02
	21-409	Singulair	Montelukast Sodium	Merck Research	3	S	26-Jul-02
1148	21-492	Eloxatin	Oxaliplatin	Sanofi-Synthelabo	1	P	09-Aug-02
1140	21-323	Lexapro	Escitalopram Oxalate	Forest Labs	3	S	14-Aug-02
	21-241	Ortho Tri Cyclen	Ethinyl Estradiol;Norgestimate	Johnson & Johnson	3	S	22-Aug-02
配	50741	DUAC	Clindamycin Phosphate;BenzoylPeroxide	Stiefel Labs	4	S	26-Aug-02
1004	21-447	Zanaflex	Tizanidine HCl	Elan Pharms	3	S	29-Aug-02
	21-428	Prevacid	Lansoprazole	TAP	3	S	30-Aug-02
	21-333	Desmopressin Acetate	Desmopressin Acetate	Ferring Pharms	5	S	16-Sep-02
	21-425	ULTRAVIST	Iopromide	Berlex Labs	3	S	20-Sep-02
1145	21-449	HEPSERA	Adefovir Dipivoxil	Gilead Sciences	1	P	20-Sep-02
1148 配	50785	Augmentin XR	Amoxicllin;Clavulanate Potassium	GlaxoSmithKline	3	S	25-Sep-02
1156	21-437	INSPRA	Eplerenone	GD Searle	1	S	27-Sep-02
	21555	Chloraprep	Chlorhexidine Gluconate	Beckloff	3	S	07-Oct-02
1150	20732	Subutex	Buprenorphine HCl	Reckitt Benckiser	3	SV	08-Oct-02
1150 配	20733	Suboxone	Buprenorphine HCl;Naloxone HCl Dihydrate	Reckitt Benckiser	4	PV	08-Oct-02
1146 配	21410	Avandamet	Metformin HCl; Rosiglitazone Maleate	GlaxoSmithKline	4	S	10-Oct-02
	20776	Daypro Alta	Oxaprozin Potassium	Pharmacia	2	S	17-Oct-02
	21408	Mentax-TC	Butenafine HCl	Bertek	3	S	17-Oct-02
	21472	Ibuprofen	Ibuprofen	Banner Pharmacaps	3	S	18-Oct-02
1146 配	21460	Metaglip	Glipizide;Metformin HCl	Bristol Myers Squibb	4	S	21-Oct-02
	21116	Thyro-Tabs	Levothyroxine Sodium	Lloyd	5	S	24-Oct-02
1151	21445	Zetia	Ezetimibe	MSP Singapore	1	S	25-Oct-02
	21454	Testim	Testosterone	Auxilium A2	3	S	31-Oct-02
	21330	Commit	Nicotine Polacrilex	GlaxoSmithKline Cons	3	S	31-Oct-02
	50763	Mytozytrex	Mitomycin	SuperGen	3	S	14-Nov-02
1150	21436	Abilify	Aripiprazole	Otsuka	1	S	15-Nov-02
1154	21498	Alinia	Nitazoxanide	Romark	1	PV	22-Nov-02
1149	21318	Forteo	Teriparatide	Lilly	3	S	26-Nov-02
1149 1189	21411	Strattera	Atomoxetine HCl	Lilly	1	S	26-Nov-02
1140	21365	Lexapro	Escitalopram Oxalate	Forest Labs	3	S	27-Nov-02
1151	21511	Copegus	Ribavirin	Roche	3	P	03-Dec-02
	50788	Mupirocin	Mupirocin	Clay Park	3	S	04-Dec-02
1147	21375	Alavert	Loratadine	Wyeth Consumer Healthcare	3*	S	12-Dec-02
1116-17	21473	Cipro XR	Ciprofloxacin	Bayer	3	S	13-Dec-02
	21314	IDkit:Hp	13C-Urea and Citrica (citric acid)	Oridion	3	S	17-Dec-02
	21419	Methylin	Methylphenidate HCl	Mallinckrodt	3	S	19-Dec-02
配	21441	Advil Allergy Sinus	Chlorpheniramine Maleate;Ibuprofen;Pseudoephedrine HCl	Wyeth Consumer Healthcare	4	S	19-Dec-02
	21484	Bravelle	Urofollitropin	Ferring Pharms	3	S	19-Dec-02
	20782	Depakote ER	Divalproex Sodium	Abbott Labs	3	S	20-Dec-02
	21321	Extraneal	Icodextrin	Baxter Healthcare	1	SV	20-Dec-02
1157	21023	Restasis	Cyclosporine	Allergan	3	P	23-Dec-02
1165	21470	Finacea	Azelaic Acid	Berlex	3	S	24-Dec-02
1155	21016	Relpax	Eletriptan Hydrobromide	Pfizer	1	S	26-Dec-02
	21478	Zovirax	Acyclovir	GlaxoSmithKline	3	S	30-Dec-02
	21453	Zerit XR	Stavudine	Bristol Myers Squibb	3	S	31-Dec-02
●NDA Approvals for Calendar Year 2001
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/ SPONSOR	CT	TC	APPROVAL DATE
	21-252	Canasa	Mesalamine	Axcan Scandipharm	5	P	05-Jan-01
0990	21-208	Remeron SolTab	Mirtazapine	Organon	3	S	12-Jan-01
1108	21-227	Cancidas	Caspofungin Acetate	Merck Research Labs	1	P	26-Jan-01
配	21-261	Monistat 3 Combination Pack	Miconazole Nitrate	Personal Products	4	S	02-Feb-01
	50-783	Periostat	Doxycycline Hyclate	Collagenex Pharms	3	S	02-Feb-01
1106	20-825	Geodon	Ziprasidone HCl	Pfizer	1	S	05-Feb-01
	21-231	Zomig ZMT	Zolmitriptan	Astra Zeneca Pharms	3	S	13-Feb-01
1104	20-831	Foradil	Formoterol Fumarate	Novartis	1	S	16-Feb-01
	50-781	Arestin	Minocycline HCl	Orapharma	3	S	16-Feb-01
1103	21-153	Nexium	Esomeprazole Magnesium	Astra Zeneca	2	S	20-Feb-01
配	21-265	Infuvite Pediatric	Multiple Vitamins	Sabex	5	S	21-Feb-01
	50-780	Cefuroxime for Injection and Dextrose for Injection in Duplex Container	Cefuroxime Sodium	B.Braun	5	S	21-Feb-01
1101	21-235	Prozac Weekly	Fluoxetine HCl	Eli Lilly	3	S	26-Feb-01
1107	21-169	Reminyl	Galantamine Hydrobromide	Janssen Research	1	S	28-Feb-01
配	21-082	Tavist Allergy/Sinus /Headache	Acetaminophen/Clemastine Fumarate/Pseudoephedrine HCl	Novartis	4	S	01-Mar-01
	21-257	Travatan	Travoprost	Alcon	1	P	16-Mar-01
	21-262	Alphagan P	Brimonidine Tartrate	Allergan	3	S	16-Mar-01
	21-275	Lumigan	Bimatoprost	Allergan	1	P	16-Mar-01
配	20-950	DuoNeb	Albuterol Sulfate/ Ipratropium Bromide	Dey Labs	4	S	21-Mar-01
1129	20-988	Protonix	Pantoprazole Sodium	Wyeth-Ayerst	3	S	22-Mar-01
	21-304	Valcyte	Valganciclovir HCl	Roche	2	P	29-Mar-01
	21-160	PhosLo	Calcium Acetate	Braintree Lab	3	S	02-Apr-01
1114	21-259	Metadate CD	Methylphenidate HCl	Celltech Pharms	3	S	03-Apr-01
	20-983	VentolinHFA	Albuterol Sulfate	GlaxoSmithKline	3	S	19-Apr-01
	20-949	AccuNeb	Albuterol Sulfate	Dey	5	S	30-Apr-01
	21-281	Prevacid	Lansoprazole	Tap Pharm	3	S	03-May-01
1124	21-001	Axert	Almotriptan Malate	Pharmacia &UpJohn	1	S	07-May-01
1106	21-335	Gleevec	Imatinib Mesylate	Novartis	1	PV	10-May-01
1133 配	21-098	Yasmin	Drospirenone/Ethinyl Estradiol	Berlex Labs	1,4	S	11-May-01
	21-285	Trileptal	Oxcarbazepine	Novartis	3	S	25-May-01
	21-301	Levoxyl	Levothyroxine Sodium	Jones Pharma	5	S	25-May-01
配	21-074	Avagard	Alcohol/Chlorhexidine Gluconate	3M	3	S	07-Jun-01
1107	21-224	Reminyl	Galantamine Hydrobromide	Janssen Research	3	S	22-Jun-01
配	50-755	Augmentin ES-600	Amoxicillin/Clavulanate Potassium	GlaxoSmithKline	3	S	22-Jun-01
配	21-105	Phenazopyridine HCl /Sulfamethoxazole /Trimethoprim	Phenazopyridine HCl/Sulfamethoxazole/Trimethoprim	Able Labs	4	S	26-Jun-01
	21-238	Kytril	Granisetron HCl	Roche	3	S	27-Jun-01
1132	21-288	Trelstar	Triptorelin Pamoate	Pharmacia and Upjohn	3	S	29-Jun-01
	21-146	Atropine Sulfate	Atropine Sulfate	Abbott	5	S	09-Jul-01
	21-283	Diovan	Valsartan	Novartis	3	S	18-Jul-01
	21-064	Definity	Perflutren	Bristol Myers Squibb	1	S	31-Jul-01
1118	20-920	Natrecor	Nesiritide	Scios	1	S	10-Aug-01
配	21-150	Zyrtec-D 12 Hour	Cetirizine HCl/Pseudoephedrine HCl	Pfizer	4	S	10-Aug-01
配	21-123	Ultracet	Acetaminophen/Tramadol HCl	RW Johnson	4	S	15-Aug-01
1120	21-223	Zometa	Zoledronic Acid	Novartis	1	P	20-Aug-01
1122	21-222	Spectracef	Cefditoren Pivoxil	Tap	1	S	29-Aug-01
	21-203	Tricor	Fenofibrate	Abbott	3	S	04-Sep-01
	21-279	Foradil Aerolizer	Formoterol Fumarate	Novartis	3*	S	25-Sep-01
1122	21-324	Entocort EC	Budesonide	AstraZeneca	3	P	02-Oct-01
配	21-187	NuvaRing	Etonogestrel/Ethinyl Estradiol Vaginal Ring	Organon	1	S	03-Oct-01
1205 配	21-303	Adderall XR	Amphetamine Aspartate Monohydrate /Amphetamine Sulfate/ Dextroamphetamine Saccharate /Dextroamphetamine Sulfate	Shire Labs	3	S	11-Oct-01
	21-317	Bayer Extra Strength Aspirin for Migraine Pain	Aspirin	Bayer	7	S	18-Oct-01
	21-356	Viread	Tenofovir Disoproxil Fumarate	Gilead Sciences	1	P	26-Oct-01
1115 配	21-172	Novolog Mix 70/30	Insulin Aspart/Insulin Aspart Protamine	Novo Nordisk	4	S	01-Nov-01
配	21-268	Teveten HCT	Eprosartan Mesylate/Hydrochlorothiazide	Unimed	4	S	01-Nov-01
1124	21-006	Frova	Frovatriptan Succinate	Elan Pharms	1	S	08-Nov-01
1130	21-278	Focalin	Dexmethylphenidate HCl	Celgene	3	S	13-Nov-01
1129	21-341	Bextra	Valdecoxib	Searle Pharms	1	S	16-Nov-01
1122 配	21-180	Ortho Evra	Ethinyl Estradiol/Norelgestromin	RW Johnson	1,4	S	20-Nov-01
1127	21-290	Tracleer	Bosentan	Actelion	1	SV	20-Nov-01
1146	21-319	Drug Name is Pending ※Avodart	Dutasteride	Glaxo SmithKline	1	S	20-Nov-01
1126	21-337	Invanz	Ertapenem Sodium	Merck	1	S	21-Nov-01
1126	21-277	Avelox	Moxifloxacin HCl in Sodium Chloride	Bayer	3	S	30-Nov-01
1130	21-345	Arixtra	Fondaparinux Sodium	Fonda BV	1	P	07-Dec-01
1131	21-302	Elidel	Pimecrolimus	Novartis	1	S	13-Dec-01
1151 配	21-249	Advicor	Lovastatin and Niacin	Kos	4	S	17-Dec-01**
1126	21-165	Clarinex	Desloratadine	Schering Plough	1	S	21-Dec-01
●NDA Approvals for Calendar Year 2000
ML	NDA NUMBER	DRUG NAME	GENERIC NAME	APPLICANT/SPONSOR	CT	TC	APPROVAL DATE
1084	20-989	Evoxac	CevimelineHCl	SnowBrand	1	S	11-Jan-00
1076	21-014	Trileptal	Oxcarbazepine	Novartis	1	S	14-Jan-00
	20-939	Diltiazem HCl	Diltiazem HCl	Biovail	5	S	28-Jan-00
	21-117	Calcium Chloride	Calcium Chloride	Abbott Labs	3	S	28-Jan-00
1083	20-987	Protonix	Pantoprazole Sodium	Wyeth Ayerst	1	S	02-Feb-00
	21-120	Trinasal	Triamcinolone Acetonide	Muro Pharms	3	S	04-Feb-00
1081	21-107	Lotronex	Alosetron HCl	GlaxoWellcome	1	P	09-Feb-00
配	21-084	Skin Exposure Reduction Paste Against Chemical Warfare Agents	Perfluoropolymethylisopropyl Ether/Polytetrafluoroethylene	U.S.Army	14	P	17-Feb-00
	21-114	Betaxon	Levobetaxolol HCl	Alcon	2	P	23-Feb-00
	20-872	Allegra	Fexofenadine HCl	Aventis Pharms	3	S	25-Feb-00
1080	21-015	AndroGel	Testosterone	Unimed Pharms	3	S	28-Feb-00
	21-129	Neurontin	Gabapentin	Parke Davis	3	S	02-Mar-00
	21-088	Viadur	Leuprolide Acetate	ALZA	3	S	03-Mar-00
	50-775	Biaxin XL	Clarithromycin	Abbott Labs	3	S	03-Mar-00
配	21-043	Rid Mousse	Piperonyl Butoxide/Pyrethrins	Soltec Research USA	3	S	07-Mar-00
	21-037	Magnevist	Gadopentetate Dimeglumine	Berlex Labs	3	S	10-Mar-00
1089	20-789	Zonegran	Zonisamide	Dainippon Pharms	1	S	27-Mar-00
配	20-971	Septocaine	Articaine HCl/Epinephrine	Deproco	14	S	03-Apr-00
	21-027	Hectorol	Doxercalciferol	Bone Care	3	S	06-Apr-00
	21-086	Zyprexa Zydis	Olanzapine	Eli Lilly	3	S	06-Apr-00
1086	21-119	Visudyne	Verteporfin	QLT Photo	1	P	12-Apr-00
	21-143	Trivagizole 3	Clotrimazole	Taro Pharms	3	S	12-Apr-00
1079	20-938	Mobic	Meloxicam	Boehringer Ingleheim Pharms	1	S	13-Apr-00
1079	21-130	Zyvox	Linezolid	Pharmacia & Upjohn	1	P	18-Apr-00
1079	21-131	Zyvox	Linezolid	Pharmacia & Upjohn	3	P	18-Apr-00
1079	21-132	Zyvox	Linezolid	Pharmacia& Upjohn	3	P	18-Apr-00
1110	21-081	Lantus	Insulin Glargine	Aventis Pharms	1	S	20-Apr-00
1110	20-823	Exelon	Rivastigmine Tartrate	Novartis Pharms	1	S	21-Apr-00
1110	21-025	Exelon	Rivastigmine Tartrate	Novartis Pharms	3	S	21-Apr-00
	21-134	Nitrostat	Nitroglycerin	Parke Davis	3	S	01-May-00
1083	21-174	Mylotarg	Gemtuzumab Ozogamicin	Wyeth Ayerst	1	PV	17-May-00
配	21-163	Multi-12	Alpha-tocopherol Acetate/ Ascorbic acid/Biotin/ Cholecaliferol/Cyanocobalamin/ Dexpanthenol/Folic acid/ Niacinamide/Pyridoxine HCl/Riboflavin Phosphate Sodium/Thiamine HCl/Vitamin A Palmitate	Sabex	5	S	18-May-00
	21-127	Optivar	Azelastine HCl	Asta Medica	3	S	22-May-00
0995	20-748	Differin	Adapalene	Galderma, L.P.	3	S	26-May-00
1091	21-141	Welchol	Colesevelam HCl	GelTex	3	S	26-May-00
	21-142	Olux	ClobetasolPropionate	Connectics	3	S	26-May-00
1091	21-176	Welchol	Colesevelam HCl	GelTex	1	S	26-May-00
1115	20-986	NovoLog	Insulin Aspart Recombinant	Novo Nordisk	1	S	07-Jun-00
1132	20-715	Trelstar Depot	Triptorelin Pamoate	Debio Recherche	1	S	15-Jun-00
	21-148	Norditropin	Somatropin Recombinant	Novo Nordisk	3	S	20-Jun-00
1075	21-056	Targretin	Bexarotene	Ligand Pharm	3	PV	28-Jun-00
1097	20-883	Acova	Argatroban	Texas Biotechnology	1	S	30-Jun-00
	21-179	Renagel	Sevelamer HCl	Geltex Pharm	3	S	12-Jul-00
配	20-832	Chloraprep	Chlorhexidine Gluconate/Isopropyl Alcohol	Medi Flex Hospital	4	S	14-Jul-00
1098	20484	Innohep	Tinzaparin Sodium	Dupont	1	S	14-Jul-00
1093 配	21-078	Malarone	Atovaquone/Proguanil HCl	Glaxo Wellcome	4	P	14-Jul-00
1109	20-610	Colazal	Balsalazide Disodium	Salix Pharm	1	S	18-Jul-00
1092	20-941	Abreva	Docosanol	Avanir Pharm	1	S	25-Jul-00
	50-779	Cefazolinand Dextrose	Cefazolin Sodium	B. Braun Medical	5	S	27-Jul-00
1089	21-145	Vaniqa	Eflornithine HCl	WestWood Squibb	3	S	27-Jul-00
1092 配	21-178	Glucovance	Glyburide/Metformin HCl	Bristol Myers Squibb	34	S	31-Jul-00
	21-121	Concerta	Methylphenidate HCl	Alza	3	S	01-Aug-00
配	21-128	Children's Motrin	Ibuprofen/Pseudoephedrine HCl	McNeil Consumer Healthcare	3	S	01-Aug-00
	21-214	Rescula	Unoprostone Isopropyl	Ciba Vision	1	P	03-Aug-00
1094	21-168	Depakote ER	Divalproex Sodium	Abbott Labs	3	S	04-Aug-00
1096	20-929	Pulmicort Respules	Budesonide	Astra	3	P	08-Aug-00
	21-197	Cetrotide	Cetrorelix Acetate	Asta Medica	1	S	11-Aug-00
	21-167	Vivelle	Estradiol	Novartis	3	S	16-Aug-00
	21-199	Quixin	Levofloxacin	Santen Inc.	3	P	18-Aug-00
	21-210	Unithroid	Levothyroxine Sodium	Jerome Stevens Pharm	7	S	21-Aug-00
1102 配	21-077	Advair Diskus	Fluticasone Propionate/ Salmeterol Xinafoate	Glaxo Wellcome	4	S	24-Aug-00
1071	21-110	Rapamune	Sirolimus	Wyeth-Ayerst	3	S	25-Aug-00
	21-108	Renova	Tretinoin	Johnson & Johnson	3	S	31-Aug-00
1113	21-011	Roxicodone	Oxycodone HCl	Roxane Labs	3	S	31-Aug-00
配	21-093	Atacand HCT	Candesartan Cilexetil Hydrochlorothiazide	AstraZeneca	4	S	05-Sep-00
	20-911	Qvar	Beclomethasone Dipropionate	3M Pharm	3	S	15-Sep-00
1095 配	21-226	Kaletra	Lopinavir/Ritonavir	Abbott Labs	14	P	15-Sep-00
1095 配	21-251	Kaletra	Lopinavir/Ritonavir	Abbott Labs	34	P	15-Sep-00
	21-149	Ovidrel	Choriogonadotropin Alfa	Serono Lab	3	S	20-Sep-00
配	21-097	Visicol	Sodium Phosphate Dibasic Anyhyrdous/Sodium Phosphate Monobasic Monohydrate	InKine Pharms	7	S	21-Sep-00
	21-248	Trisenox	Arsenic Trioxide	Cell Therapeutics	1	PV	25-Sep-00
1091	20-687	Mifeprex	Mifepristone	Population Council	1	P	28-Sep-00
	20-833	Flovent Diskus	Fluticasone Propionate	Glaxo	3	S	29-Sep-00
1132	21-184	Tazorac	Tazarotene	Allergan	3	S	29-Sep-00
配	20-874	Lunelle	Estradiol Cypionate/ Medroxyprogesterone Acetate	Pharmacia & Upjohn	4	S	05-Oct-00
	21-192	Lescol XL	Fluvastatin Sodium	Novartis Pharms	3	S	06-Oct-00
	21-216	Neurontin	Gabapentin	Parke Davis	3	S	12-Oct-00
1100	21-202	Glucophage XR	Metformin HCl	Bristol Myers	3	S	13-Oct-00
配	20-958	Pepcid Complete	CalciumCarbonate/ Famotidine/Magnesium Hydroxide	Merck Labs	4	S	16-Oct-00
	21-005	Solaraze	Diclofenac Sodium	SkyePharma	3	S	16-Oct-00
	20-985	Fluorouracil	Fluorouracil	Dermik Lab	3	S	27-Oct-00
	21-183	Videx EC	Didanosine	Bristol-Myers Squibb	3	P	31-Oct-00
	21-135	Venofer	Iron Sucrose	Luitpold Pharm	3	S	06-Nov-00
配	21-205	Trizivir	Abacavir Sulfate/Lamivudine/Zidovudine	Glaxo Wellcome	3	P	14-Nov-00
配	21-162	Micardis HCT	Hydrochlorothiazide/Telmisartan	Boehringer Pharms	4	S	17-Nov-00
	50-782	Clindamycin	Clindamycin Phosphate	Clindagel	3	S	27-Nov-00
配	50-769	Benzamycin Pak	BenzoylPeroxide/Erythromycin	Dermik Labs	3	S	27-Nov-00
配	21-140	Imodium Advanced	Loperamide HCl/ Simethicone	McNeil Cons	3	S	30-Nov-00
1096	21-225	Mirena	Levonorgestrel	Berlex Labs	3	S	06-Dec-00
配	20-010	Lotrisone	Betamethasone Diproprionate/ Clotrimazole	Schering-Plough	34	S	08-Dec-00
1102	50-777	Protopic	Tacrolimus	Fujisawa Healthcare	3	S	08-Dec-00
1063	21-246	Tamiflu	Oseltamivir Phosphate	Hoffmann-La Roche	3	P	14-Dec-00
1103	20-873	Angiomax	Bivalirudin	The Medicines Co.	1	S	15-Dec-00
	21-190	Buspar	Buspirone Hydrochoride	Bristol Myers Squibb	3	S	20-Dec-00
配	21-090	Cyclessa	Desogestrel/Ethinyl Estradiol	Organon	3	S	20-Dec-00
配	50-756	BenzaClin	BenzoylPeroxide/Clindamycin	Dermik Labs	4	S	21-Dec-00
1101	21-204	Starlix	Nateglinide	Novartis Pharms	1	S	22-Dec-00
1101	21-228	Detrol LA	Tolterodine Tartrate	Pharmacia & Upjohn	3	S	22-Dec-00
●NDA Approvals for Calendar Year 1999
ML	NDA #	DRUG NAME	GENERIC NAME	SPONSOR/APPLICANT	CT	TC	APPROVAL DATE
1052	20-863	PLETAL	CILOSTAZOL	OTSUKA Pharm	1	S	15-Jan-99
	20-781	ZOFRAN ODT	ONDANSETRON	GLAXO Wellcome	2	S	27-Jan-99
	20-886	PANRETIN	ALITRETINOIN	LIGAND	1	PV	02-Feb-99
	20-900	PYLORI-CHEK	C-13 UREA	ALIMENTERICS	5	S	04-Feb-99
	20-954	BUSULFEX	BUSULFAN	ORPHAN MEDCL	3	PV	04-Feb-99
	20-936	PAXIL	PAROXETINE HCl	SKB PharmS	3	S	16-Feb-99
	20-698	MIRALAX	POLYETHYLENE GLYCOL 3350	BRAINTREE Labs	3	S	18-Feb-99
	20-955	FERRLECIT	SODIUM FERRIC GLUCONATE	R AND D Labs	1	P	18-Feb-99
	20-969	UVADEX	METHOXSALEN	THERAKOS	3	S	25-Feb-99
	20-934	LUXIQ	BETAMETHASONE VALERATE	CONNETICS	3	S	28-Feb-99
	20-974	PROZAC	FLUOXETINE HCl	LILLY	3	S	09-Mar-99
	20-612	LIDODERM	LIDOCAINE	TEIKOKU PharmA USA	3	SV	19-Mar-99
1058	20-992	CENESTIN	SYNTHETIC CONJUGATED ESTROGENS	DURAMED PharmS	3	S	24-Mar-99
1054	20-837	XOPENEX	LEVALBUTEROL HCl INH	SEPRACOR	3	S	25-Mar-99
	20-908	VAGIFEM	ESTRADIOL	NOVO Nordisk PHARM	3	S	26-Mar-99
0966	20-966	SPORANOX	ITRACONAZOLE	JANSSEN	3	S	30-Mar-99
	21-041	DEPOCYT	CYTARABINE	SKYE PharmA	3	P	01-Apr-99
配	20-924	CERNEVIT-12	MULTIVITAMINS	BAXTER HLTHCARE	3	S	06-Apr-99
1057	21-007	AGENERASE	AMPRENAVIR	GLAXO Wellcome	1	P	15-Apr-99
1057	21-039	AGENERASE	AMPRENAVIR	GLAXO Wellcome	3	P	15-Apr-99
	50-760	AMOXIL	AMOXICILLIN	SKB PharmS	3	S	15-Apr-99
	50-761	AMOXIL	AMOXICILLIN	SKB PharmS	3	S	15-Apr-99
1055	20-766	XENICAL	ORLISTAT	ROCHE	1	P	23-Apr-99
1056	21-042	VIOXX	ROFECOXIB	MERCK RES	1	P	20-May-99
1056	21-052	VIOXX	ROFECOXIB	MERCK RES	3	P	20-May-99
1059	21-071	AVANDIA	ROSIGLITAZONE MALEATE	SKB PharmS	1	P	25-May-99
	20-862	HECTOROL	DOXERCALCIFEROL	BONE CARE	1	S	09-Jun-99
	20-945	NORVIR	RITONAVIR	ABBOTT Labs	3	S	29-Jun-99
	20-968	MONISTAT DUAL- PAK	MICONAZOLE NITRATE	ADVANCED CARE PRODS	3	S	30-Jun-99
1077	21-066	ZADITOR	KETOTIFEN FUMARATE	CIBA VISION	1	P	02-Jul-99
	20-951	TAGAMET	CIMETIDINE	SKB CONS HLTHCARE	3	S	09-Jul-99
1066	21-073	ACTOS	PIOGLITAZONE HCl	TAKEDA AMERICA	1	P	15-Jul-99
	21-028	VELOSULIN BR	HUMAN INSULIN	NOVO Nordisk PHARM	3	S	19-Jul-99
1063	21-036	RELENZA	ZANAMIVIR	GLAXO Wellcome	1	P	26-Jul-99
	21-045	LEVONORGESTREL	LEVONORGESTREL	WOMENS CAPITAL	3	P	28-Jul-99
	21-057	ANTAGON	GANIRELIX ACETATE	ORGANON INC	1	P	29-Jul-99
	21-012	NEO TECT KIT	TECHNETIUM Tc-99m DEPREOTIDE	DIATIDE	1	P	03-Aug-99
	20-902	PEPCID AC	FAMOTIDINE	MERCK RES	3	S	05-Aug-99
	20-997	CHIROCAINE	LEVOBUPIVACAINE HCl	PURDUE PharmA LP	2	S	05-Aug-99
1068	21-029	TEMODAR	TEMOZOLOMIDE	SCHERING	1	PV	11-Aug-99
1063	20-859	SONATA	ZALEPLON	WYETH AYERST LABS	1	S	13-Aug-99
	50-767	CLEOCIN	CLINDAMYCIN PhosPHATE	PHARMACIA AND UPJOHN	3	S	13-Aug-99
	20-984	RAPLON	RAPACURONIUM BROMIDE	ORGANON	1	S	18-Aug-99
1066	20-973	ACIPHEX	RABEPRAZOLE Sodium	EISAI (US)	1	S	19-Aug-99
1071	21-083	RAPAMUNE	SIROLIMUS	WYETH AYERST LABS	1	P	15-Sep-99
1071	50-778	ELLENCE	EPIRUBICIN HCl	PHARMACIA AND UPJOHN	1	P	15-Sep-99
	21-048	ESTRADIOL TRANSDERMAL SYSTEM	ESTRADIOL	WYETH AYERST LABS	3	S	20-Sep-99
	20-793	CAFCIT	CAFFEINE CITRATE SOL	OPR DEVELOP LP	2	PV	21-Sep-99
1066 配	50-747	SYNERCID	DALFOPRISTIN/QUINUPRISTIN	RHONE POULENC RORER	1	P	21-Sep-99
1066 配	50-748	SYNERCID	DALFOPRISTIN/QUINUPRISTIN	RHONE POULENC RORER	3	S	21-Sep-99
1077	21-079	ALAMAST	PEMIROLAST POTASSIUM	SANTEN	1	P	24-Sep-99
	20-746	RHINOCORT AQUA	BUDESONIDE	ASTRA PharmS	3	S	01-Oct-99
1078	20-931	TIKOSYN	DOFETILIDE	PFIZER	1	S	01-Oct-99
	21-019	COMPAZINE	PROCHLORPERAZINE MALEATE	SKB PharmS	3	S	06-Oct-99
配	21-065	FEMHRT	ETHINYLESTRADIOL/ NORETHINDRONE	PARKE DAVIS	3	S	15-Oct-99
1070	20-796	COMTAN	ENTACAPONE	ORION	1	S	19-Oct-99
1076	20-753	AROMASIN	EXEMESTANE	PHARMACIA AND UPJOHN	1	SV	21-Oct-99
配	21-040	ORTHO-PREFEST	ESTRADIOL/NOREGESTIMATE	JOHNSON RW	4	S	22-Oct-99
1063	21-087	TAMIFLU	OSELTAMIVIR PhosPHATE	ROCHE	1	P	27-Oct-99
1074	20-744	CUROSURF	PORACTANT	DEY Labs	1	SV	18-Nov-99
1071 配	20-884	AGGRENOX	ASPIRIN/EXTENDED-RELEASE DIPYRIDAMOLE	BOEHRINGER INGELHEIM	4	P	22-Nov-99
配	21-076	ALEVE COLD & SINUS	NAPROXIN Sodium AND PSEUDOEPHEDRINE HCl EXTENDED RELEASE	BAYER	4	S	29-Nov-99
1076	21-035	KEPPRA	LEVETIRACETAM	UCB PharmA	1	S	30-Nov-99
1133	20-965	LEVULAN KERASTICK	AMINOLEVULINIC ACID HCl	DUSA PharmA	1	S	03-Dec-99
	20-990	ZOLOFT	SERTRALINE HCl	PFIZER	3	S	07-Dec-99
	20-937	OPTIMARK	GADOVERSETAMIDE	MALLINCKRODT	1	S	08-Dec-99
	20-975	OPTIMARK	GADOVERSETAMIDE	MALLINCKRODT	3	S	08-Dec-99
	20-976	OPTIMARK	GADOVERSETAMIDE	MALLINCKRODT	3	S	08-Dec-99
1077	21-009	ALOCRIL	NEDOCROMIL Sodium	ALLERGAN	3	P	08-Dec-99
配	20-922	SOLAGE	MEQUINOL/TRETINOIN	BRISTOL-MYERS SQUIBB	1,4	S	10-Dec-99
1072	21-085	AVELOX	MOXIFLOXACIN HCl	BAYER	1	S	10-Dec-99
	21-092	HELICOSOL	C-13 UREA	METABOLIC SOLUTION	5	S	17-Dec-99
1080	21-022	PENLAC NAIL LACQUER	CICLOPIROX	AVENTIS PharmS	3	S	17-Dec-99
	21-038	PRECEDEX	DEXMEDETOMIDINE HCl	ABBOTT Labs	1	S	17-Dec-99
1072	21-061	TEQUIN	GATIFLOXACIN	BRISTOL Myers SQUIBB	1	S	17-Dec-99
1072	21-062	TEQUIN	GATIFLOXACIN	BRISTOL Myers SQUIBB	3	S	17-Dec-99
1041	21-046	CELEXA	CITALOPRAM HYDROBROMIDE	FOREST Labs	3	S	22-Dec-99
配	21-017	HUMALOG MIX 75/25	INSULIN LISPRO/INSULIN LISPRO PROTAMINE	ELI LILLY	3,4	S	22-Dec-99
配	21-018	HUMALOG MIX 50/50	INSULIN LISPRO/INSULIN LISPRO PROTAMINE	ELI LILLY	3,4	S	22-Dec-99
	21-075	NUTROPIN DEPOT	SOMATROPIN	GENENTECH	3	PV	22-Dec-99
	20-845	INO MAX	NITRIC OXIDE	INO THERAPEUTICS	1	PV	23-Dec-99
配	20-125	ACCURETIC	QUINAPRIL/HCTZ	PARKE-DAVIS	4	S	28-Dec-99
	21-055	TARGRETIN	BEXAROTENE	LIGAND Pharm	1	PV	29-Dec-99

ML	NDA Number	DRUG NAME	GENERIC NAME	APPLICANT	分類#	APPROVAL DATE	DOSAGE FORM
●NDA Approvals for Calendar Year 1998
	20-181	LIPOSYN III	SOYBEAN OIL	ABBOTT LABS	3 S	13-Jan-98	INJECTION
配	20-802	EXCEDRIN	ACETAMINOPHEN/ASPIRIN/ CAFFEINE	BRISTOL MYERS	7 S	14-Jan-98	TABLET
1028	20-697	TASMAR	TOLCAPONE	HOFFMAN LA-ROCHE	1 S	29-Jan-98	TABLET
	20-812	PEDIATRIC ADVIL	IBUPROFEN	WHITEHALL ROBINS	3 S	30-Jan-98	SUSPENSION
	50-731	DAUNORUBICIN HCL	DAUNORUBICIN HCl	BEDFORD LABS	3 S	30-Jan-98	INJECTION
配	20-962	EMLA	LIDOCAINE/PRILOCAINE	ASTRA PHARMS	3 S	4-Feb-98	DISC
1037	20-763	AMERGE	NARATRIPTAN HCl	GLAXO WELLCOME	1 S	10-Feb-98	TABLET
配	20-805	CIPRO HC	CIPROFLOXACIN HCl/ HYDROCORTISONE	BAYER	3 S	10-Feb-98	SUSPENSION
1031	20-829	SINGULAIR	MONTELUKAST SODIUM	MERCK	1 S	20-Feb-98	TABLET
1031	20-830	SINGULAIR	MONTELUKAST SODIUM	MERCK	3 S	20-Feb-98	TABLET
配	50-750	ZOSYN	PIPERACILLIN SODIUM/ TAZOBACTAM SODIUM	LEDERLE	3 S	24-Feb-98	INJECTION
	20-745	ZANTAC 75	RANITIDINE HCl	GLAXO WELLCOME	3 S	26-Feb-98	TABLET
	20-906	ETOPOPHOS	ETOPOSIDE PHOSPHATE	BRISTOL MYERS SQUIBB	3 S	27-Feb-98	INJECTION
1036	20-807	REFLUDAN	LEPIRUDIN	HOECHST MARION RSSL	1 P	6-Mar-98	INJECTION
配	20-818	DIOVAN HCT	HYDROCHLOROTHIAZIDE/ VALSARTAN	NOVARTIS PHARMS	4 S	6-Mar-98	TABLET
	20-583	LOTEMAX	LOTEPREDNOL ETABONATE	PHARMOS	1 S	9-Mar-98	SUSPENSION
	20-803	ALREX	LOTEPREDNOL ETABONATE	PHARMOS	3 S	9-Mar-98	SUSPENSION
1038	20-771	DETROL	TOLTERODINE TARTRATE	PHARMACIA & UPJOHN	1 S	25-Mar-98	TABLET
1034	20-835	ACTONEL	RISEDRONATE SODIUM	PROCTER & GAMBLE PHARM	1 S	27-Mar-98	TABLET
1026	20-895	VIAGRA	SILDENAFIL CITRATE	PFIZER	1 P	27-Mar-98	TABLET
	20-369	CILOXAN	CIPROFLOXACIN HCl	ALCON	3 S	30-Mar-98	OINTMENT
	20-827	MONISTAT 3	MICONAZOLE NITRATE	ADVANCED CARE	3 S	30-Mar-98	CREAM
1036	20-816	AZOPT	BRINZOLAMIDE	ALCON	1 S	1-Apr-98	SUSPENSION
配	20-869	COSOPT	DORZOLAMIDE HCl/ TIMOLOL MALEATE	MERCK RES	4 S	7-Apr-98	SOLUTION
	20-772	SUCRAID	SACROSIDASE	ORPHAN MEDCL	1 P	9-Apr-98	SOLUTION
	20-819	ZEMPLAR	PARICALCITOL	ABBOTT LAB	1 S	17-Apr-98	INJECTION
	20-713	MIRCETTE	DESOGESTREL/ ETHINYL ESTRADIOL	ORGANON	3 S	22-Apr-98	TABLET
	20-846	LAMISIL	TERBINAFINE	NOVARTIS PHARMS	3 S	29-Apr-98	GEL
1039	20-896	XELODA	CAPECITABINE	HOFFMAN LA-ROCHE	1 P	30-Apr-98	TABLET
	20-809	DICLOFENAC SODIUM	DICLOFENAC SODIUM	FALCON PHARMS	3 S	4-May-98	SOLUTION
	19-781	PROMETRIUM	PROGESTERONE	SCHERING PLOUGH	3 S	14-May-98	CAPSULE
1035	20-912	AGGRASTAT	TIROFIBAN HCl	MERCK	1P	14-May-98	INJECTION
1035	20-913	AGGRASTAT	TIROFIBAN HCl	MERCK	3P	14-May-98	INJECTION
	20-774	PERIOCHIP	CHLORHEXIDINE GLUCONATE	PERIO PRODS	3 S	15-May-98	TABLET
1035	20-718	INTEGRILIN	EPTIFIBATIDE	COR	1 P	18-May-98	INJECTION
	20-752	PEPCID RPD	FAMOTIDINE	MERCK	3 S	28-May-98	TABLET
	20-923	OPTIRAY	IOVERSOL	MALLINCKRODT MEDCL	3 S	29-May-98	INJECTION
	20-903	REBETOL	RIBAVIRIN	SCHERING PLOUGH RES	3 P	3-Jun-98	CAPSULE
1040	20-838	ATACAND	CANDESARTAN CILEXETIL	ASTRA MERCK PHARMS	1 S	4-Jun-98	TABLET
	19-832	SULFAMYLON	MAFENIDE ACETATE	MYLAN PHARMS	3 S	5-Jun-98	POWDER, FOR RECONSTITUTION
	20-918	GLUCAGEN	GLUCAGON HCl RECOMBINANT	NOVO NORDISK PHARM	3 P	22-Jun-98	INJECTION
1047	21-024	PRIFTIN	RIFAPENTINE	HOECHST MARION RSSL	1 P	22-Jun-98	TABLET
1037	20-864	MAXALT	RIZATRIPTAN BENZOATE	MERCK	1 S	29-Jun-98	TABLET
1037	20-865	MAXALT	RIZATRIPTAN BENZOATE	MERCK	3 S	29-Jun-98	TABLET
	50-754	AMOXIL	AMOXICILLIN	SKB PHARMS	3 S	10-Jul-98	TABLET
配	20-860	LEVLITE	ETHINYL ESTRADIOL/ LEVONORGESTREL	BERLEX LABS	3 S	13-Jul-98	TABLET
1038	20-785	THALOMID	THALIDOMIDE	CELGENE	1 P	16-Jul-98	CAPSULE
1041	20-822	CELEXA	CITALOPRAM HYDROBROMIDE	FOREST LABS	1 S	17-Jul-98	TABLET
	20-847	ESCLIM	ESTRADIOL	FOURNIER RES	3 S	4-Aug-98	FILM, CONTROLLED RELEASE
配	20-870	COMBIPATCH	ESTRADIOL/NORETHINDRONE ACETATE	RHONE POULENC RORER	3 S	7-Aug-98	FILM, CONTROLLED RELEASE
	50-758	CELLCEPT	MYCOPHENOLATE MOFETIL HCl	GLAXOSMITHKLINE	3 S	12-Aug-98	INJECTION
	20-764	LAMICTAL CD	LAMOTRIGINE	GLAXO WELLCOME	3 S	24-Aug-98	TABLET
	20-849	PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER	AMINO ACIDS	BAXTER HLTHCARE	3 S	26-Aug-98	INJECTION
	20-961	VITRAVENE PRESERVATIVE FREE	FOMIVIRSEN SODIUM	NOVARTIS	1 P	26-Aug-98	INJECTION
	20-946	PREVEN	ETHINYL ESTRADIOL/ LEVONORGESTREL	GYNETICS	3 P	1-Sep-98	TABLET
	50-751	ATRIDOX	DOXYCYCLINE HYCLATE	ATRIX	3 S	3-Sep-98	LIQUID, EXTENDED RELEASE
1040	20-905	ARAVA	LEFLUNOMIDE	AVENTIS PHARMS	1 P	10-Sep-98	TABLET
	20-928	GLUCAGON	GLUCAGON, RECOMBINANT	LILLY	3 P	11-Sep-98	INJECTION
	20-933	VIRAMUNE	NEVIRAPINE	BOEHRINGER PHARMS	3 P	11-Sep-98	SUSPENSION
	20-887	ACUTECT	TECHNETIUM TC-99M APCITIDE	DIATIDE	1 P	14-Sep-98	INJECTION
1041	20-972	SUSTIVA	EFAVIRENZ	DUPONT PHARMS	1 P	17-Sep-98	CAPSULE
	20-801	PEPCID AC	FAMOTIDINE	MERCK RES	3 S	24-Sep-98	TABLET
1049	20-892	VALSTAR	VALRUBICIN	ANTHRA	1 P	25-Sep-98	SOLUTION
	50-744	PERIOSTAT	DOXYCYCLINE HYCLATE	COLLAGENEX	3 S	30-Sep-98	CAPSULE
0958	50-759	CELLCEPT	MYCOPHENOLATE MOFETIL	ROCHE GLOBAL DEV	3 S	1-Oct-98	SUSPENSION
	20-882	NEURONTIN	GABAPENTIN	PARKE DAVIS	3 S	9-Oct-98	TABLET
	20-885	PAXIL	PAROXETINE HCl	SKB PHARMS	3 S	9-Oct-98	CAPSULE
	20-942	VERSED	MIDAZOLAM HCl	HOFFMAN LA-ROCHE	3 P	15-Oct-98	SYRUP
	20-963	TIMOLOL MALEATE	TIMOLOL MALEATE	FALCON PHARMS	3 S	21-Oct-98	SOLUTION
1001	20-844	TOPAMAX	TOPIRAMATE	JOHNSON RW	3 S	26-Oct-98	CAPSULE
	20-932	ROXICODONE	OXYCODONE HCl	ROXANE	3 S	26-Oct-98	TABLET
	20-773	SONORX	SIMETHICONE-CELLULOSE	BRACCO DXS	3 S	29-Oct-98	SUSPENSION
	20-926	RENAGEL	SEVELAMER HCl	GELTEX PHARM	1 S	30-Oct-98	CAPSULE
	20-747	ACTIQ	FENTANYL CITRATE	ANESTA	3 S	4-Nov-98	TROCHE/LOZENGE
1065	20-850	MICARDIS	TELMISARTAN	BOEHRINGER INGELHEIM	1 S	10-Nov-98	TABLET
配	20-907	ACTIVELLE	ESTRADIOL/ NORETHINDRONE ACETATE	NOVO NORDISK	4 S	18-Nov-98	TABLET
	21-068	ROCALTROL	CALCITRIOL	ROCHE	3 S	20-Nov-98	SOLUTION
	20-574	GYNE-LOTRIMIN 3	CLOTRIMAZOLE	SCHERING PLOUGH	3 S	24-Nov-98	CREAM
	20-901	METROLOTION	METRONIDAZOLE	GALDERMA	3 S	24-Nov-98	LOTION
	21-008	SANDOSTATIN LAR	OCTREOTIDE ACETATE	NOVARTIS PHARM	3 P	25-Nov-98	INJECTION
	20-943	VERELAN PM	VERAPAMIL HCl	ELAN PHARM	3 S	25-Nov-98	CAPSULE
	20-898	THYROGEN	THYROTROPIN ALFA	GENZYME	1 P	30-Nov-98	INJECTION
	20-843	PROMETRIUM	PROGESTERONE	SCHERING PLOUGH	3 S	16-Dec-98	CAPSULE
1101	20-897	DITROPAN XL	OXYBUTYNIN CHLORIDE	ALZA	3 S	16-Dec-98	TABLET
1041	20-977	ZIAGEN	ABACAVIR SULFATE	GLAXO WELLCOME	1 P	17-Dec-98	TABLET
1041	20-978	ZIAGEN	ABACAVIR SULFATE	GLAXO WELLCOME	3 P	17-Dec-98	SOLUTION
	20-944	ADVIL	IBUPROFEN	WHITEHALL ROBINS	3 S	18-Dec-98	TABLET
配	50-762	TROVAN\ZITHROMAX COMPLIANCE PAK	AZITHROMYCIN DIHYDRATE/ TROVAFLOXACIN MESYLATE	PFIZER	4 S	18-Dec-98	FOR SUSPENSION; TABLET
1049	20-717	PROVIGIL	MODAFINIL	CEPHALON	1 S	24-Dec-98	TABLET
1045	20-998	CELEBREX	CELECOXIB	SEARLE	1 P	31-Dec-98	CAPSULE

 * NDA 21209, SecreFlo - Chemical Type for this drug product is a 6 but for repo
rting purposes original reports are not changed.
 * NDA 21299, Asimia was tentatively approved on March 11,  2002.
　
Chemical Types:
1 -   New molecular entity
　2 -   New ester, new salt, or other noncovalent derivative
3 -   New formulation
4 -   New combination
5 -   New manufacturer
6 -   New indication (Beginning in 1994, Type 6's were tracked as efficacy supplements, not as NDAs.)
7 -   Drug already marketed, but without an approved NDA
P -   Priority Review - Significant improvement compared to marketed products, i
n the treatment, diagnosis, or prevention of a disease.
S -   Standard Review - The drug appears to have therapeutic qualities similar t
o those of one or more already marketed drugs

■NME Drug and New Biologic Approvals

整列＝承認日順

 New Molecular Entities (NMEs)

区分Application Type

Review Classification:  
P -   Priority Review - 優先処理
Significant improvement compared to marketed products, in the treatment, diagnos
is, or prevention of a disease.
S -   Standard Review - 通常処理
Products that do not qualify for priority review.
O -  Orphan Designation - オーファン指定
Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

●NME Drug and New Biologic Approvals in 2009
Updated through June 30, 2009
ML	区分	NDA Number	Proprietary Name	Established Name	Applicant	分類	承認日	適応症
	N	022256	SAVELLA	MILNACIPRAN HYDROCHLORIDE	CYPRESS BIOSCIENCE	S	14-Jan-09	PROVIDES FOR THE TREATMENT OF FIBROMYALGIA SYNDROME
	N	021856	ULORIC	FEBUXOSTAT	TAKEDA	S	13-Feb-09	PROVIDES FOR THE CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT.
	N	022334	AFFINITOR	EVEROLIMUS	NOVARTIS	P	30-Mar-09	PROVIDES FOR THE TREATMENT OF ADVANCED RENAL CELL CARCINOMA
	N	022268	COARTEM	ARTEMETHER/ LUMEFANTRINE	NOVARTIS	P,O	07-Apr-09	PROVIDES FOR THE TREATMENT OF INFECTIONS DUE TO PLASMODIUM FALCIPARUM OR MIXED INFECTIONS INCLUDING P.FALCIPARUM
	N	022129	PHYXXLICE	BENZYL ALCOHOL	SCIELE PHARMA	S	09-Apr-09	PROVIDES FOR PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITAS (HEAD LICE) OF THE SCALP HAIR
	L	125289	SIMPONI	GOLIMUMAB	CENTOCOR ORTHO BIOTECH	S	24-Apr-09	PROVIDES FOR THE TREATMENT OF RHEUMATOID ARTHRITIS, PSORIATIC ARTHRITIS, AND ANKYLOSING SPONDYLITIS.
	L	125274	DYSPORT	ABOBOTULINUMTOXIN A	IPSEN BIOPHARM	S	29-Apr-29	PROVIDES FOR TREATMENT OF CERVICAL DYSTONIA (SPASMODIC TORTICOLLIS)
	N	022192	FANAPT	ILOPERIDONE	VANDA PHARMS INC	S	06-May-09	PROVIDES FOR THE ACUTE TREATMENT OF SCHIZOPHRENIA IN ADULTS.
	N	022275	SAMSCA	TOLVAPTAN	OTSUKA AMERICA PHARM	S	19-May-09	PROVIDES FOR THE TREATMENT OF CLINICALLY SIGNIFICANT HYPERVOLEMIC AND EUVOLEMIC HYPONATREMIA INCLUDING PATIENTS WITH SAIDH, HEART FAILURE, AND CIRRHOSIS.
	N	022308	BESIVANCE	BESIFLOXACIN	BAUSCH AND LOMB	S	28-May-09	PROVIDES FOR THE TREATMENT OF BACTERIAL CONJUNCTIVITIS.
L	125319	CANAKINUMAB	ILARIS	NOVARTIS	P	17-Jun-09	PROVIDES FOR THE TREATMENT OF CRYOPYRIN ASSOCIATED PERIODIC SYNDROME (CAPS) IN PEDIATRICS AND ADULTS
●NME Drug and New Biologic Approvals in 2008
ML	区分	NDA Number	Proprietary Name	Established Name	Applicant	分類	承認日	適応症
	N	022187	INTELENCE	ETRAVIRINE	TIBOTEC	P	18-Jan-08	PROVIDES IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE THE TREATMENT OF HIV-1 INFECTION IN TREATMENT-EXPERIENCED ADULT PATIENTS, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1 STRAINS RESISTANT TO A NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR (NNRTI) AND OTHER ANTIRETROVIRAL AGENTS.
	N	021992	PRISTIQ	DESVENLAFAXINE SUCCINATE	WYETH	S	29-Feb-08	PROVIDES TREATMENT OF MAJOR DEPRESSIVE DISORDER.
	N	022249	TREANDA	BENDAMUSTINE HYDROCHLORIDE	CEPHALON	P	20-Mar-08	PROVIDES FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL).
	N	022161	LEXISCAN	REGADENOSON	CV THERAPEUTICS	S	10-Apr-08	PROVIDES FOR THE USE AS A PHARMACOLOGIC STRESS AGENT FOR RADIONUCLIDE MYOCARDIAL PERFUSION IMAGING 0.4 MG/5 ML (0.08MG/ML).
	N	021964	RELISTOR	METHYLNALTREXONE BROMIDE	PROGENICS	S	24-Apr-08	PROVIDES FOR THE TREATMENT OF OPIOID-INDUCED CONSTIPATION IN PATIENTS WITH ADVANCED ILLNESS WHO ARE RECEIVING PALLIATIVE CARE, WHEN RESPONSE TO LAXATIVE THERAPY HAS NOT BEEN SUFFICIENT.
	N	021775	ENTEREG	ALVIMOPAN	ADOLOR	S	20-May-08	PROVIDES TREATMENT OF FOR THE ACCELERATION OF TIME TO GASTROINTESTINAL RECOVERY FOLLOWING PARTIAL LARGE OR SMALL BOWEL RESECTION SURGERY WITH PRIMARY ANASTOMOSIS.
	N	022212	DUREZOL	DIFLUPREDNATE	SIRION	P	23-Jun-08	PROVIDES TREATMENT OF INFLAMMATION AND PAIN ASSOCIATED WITH OCULAR SURGERY.
	N	022090	EOVIST INJECTION	GADOXETATE DISODIUM	BAYER	S	03-Jul-08	PROVIDES TREATMENT FOR USE IN MAGNETIC RESONANCE IMAGING (MRI) OF THE LIVER IN ADULT PATIENTS TO PROVIDE CONTRAST IN THE T1 WEIGHTED IMAGES TO AID IN THE DETECTION AND CHARACTERIZATION OF FOCAL LIVER PATHOLOGIES IN PRE-SURGICAL EVALUATION.
	N	022156	CLEVIPREX	CLEVIDIPINE BUTYRATE	MEDICINES COMPANY	S	01-Aug-08	REDUCES BLOOD PRESSURE WHEN USE OF ORAL THERAPY IS NOT FEASIBLE.
	N	021894	XENAZINE	TETRABENAZINE	PRESTWICK	P	15-Aug-08	PROVIDES TREATMENT FOR THE CHOREA OF HUNTINGTON'S DISEASE.
	N	022290	ADRE VIEW	IOBENUANE I 123 INJECTION	GE HEALTHCARE	P	19-Sep-08	PROVIDES FOR THE DETECTION OF PRIMARY OR METASTATIC PHEOCHROMOCYTOMAS.
	N	022206	RAPAFLO	SILODOSIN	WATSON LABS	S	08-Oct-08	PROVIDES TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTHETIC HYPERPLASIA
	N	022253	VIMPAT TABLETS	LACOSAMIDE	SCHWARZ BIOSCIENCES	S	28-Oct-08	PROVIDES ADJUNCTIVE THERAPY TREATMENT OF PARTIAL ONSET SEIZERS IN PTS WITH EPILEPSY.
	N	022030	TOVIAZ	FESOTERODINE FUMARATE	PFIZER	S	31-Oct-08	PROVIDES FOR THE TREATMENT OF OVERACTIVE BLADDER.
	N	021911	BANZEL ORAL TABS	RUFINAMIDE 100/200/400MG TABLETS	EISAI	S	14-Nov-08	PROVIDES FOR THE TREATMENT OF SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME
	N	022291	PROMACTA	ELTROMBOPAG OLAMINE	GLAXOSMITHKLINE	P	20-Nov-08	PROVIDES FOR THE TREATMENT OF SHORT TERM IDIOPATHIC THROMBOCYTOPAENIC PUPURA (ITP)
	N	022304	TAPENTADOL	TAPENTADOL	ORTHO MCNEIL JANSSEN	S	20-Nov-08	PROVIDES FOR THE TREATMENT OF MODERATE TO SEVERE ACUTE PAIN
	★BLA承認
		125249	ARCALYST※[日]未	RILONACEPT	REGENERON	P,O	27-Feb-08	(熱症候群)PROVIDES TREATMENT FOR CRYOPYRIN-ASSOCIATED PERIODIC SYNDROMES (CAPS).
		125160	CIMZIA※[日]大塚・UCB2009年初申請予定	CERTOLIZUMAB PEGOL	UCB	S	22-Apr-08	(クローン病)PROVIDES FOR THE TREATMENT OF REDUCING THE SIGNS AND SYMPTOMS OF CROHN'S DISEASE AND MAINTAINING CLINICAL RESPONSE IN ADULT PATIENTS WITH MODERATELY TO SEVERELY ACTIVE DISEASE WHO HAVE AN INADEQUATE RESPONSE TO CONVENTIONAL THERAPY.
		125196	PEGPAK	PEGINTERFERON; RIBAVIRIN	SCHERING	S	13-Jun-08	COMBINATION THERAPY WITH RIBAVIRIN FOR THE TREATMENT OF CHRONIC HEPATITIS C.
		125268	NPLATE	ROMIPLOSTIM	AMGEN	P	22-Aug-08	PROVIDES TREATMENT FOR IDIOPATHIC (IMMUNE) THROMBOCYTOPENIC PURPURA.

●NME Drug and New Biologic Approvals in 2007
ML	NDA Number	Proprietary Name	Established Name	Applicant	分類	承認日	適応症
	N021977	Vyvanse	lisdexamfetamine dimesylate	New River	S	23-Feb-07	Provides for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD).
	N021985	Tekturna	aliskiren	Novartis	S	05-Mar-07	Provides for the treatment of hypertension.
	N022059	Tykerb※[日]GSK申請2007.3.30	lapatinib	GlaxoSmithKline	P	13-Mar-07	(乳癌)Provides for the treatment of patients with advanced or metastatic breast cancer whose tumors over-express HER2 (ErbB2) and who have received prior therapy including and anthracycline, a taxane and trastuzumab..
	N022055	Altabax	retapamulin	GlaxoSmithKline	S	12-Apr-07	Provides for the treatment of impetigo.
	N021829	Neupro	rotigotine	Schwarz BioSciences	S	09-May-07	Provides for the treatment of the signs and symptoms of early-stage idiopathic Parkinson’s disease.
	N022088	Torisel	temsirolimus	Wyeth	P,O	30-May-07	Provides for the treatment of advanced renal cell carcinoma.
	N022081	Letairis	ambrisentan	Gilead Sciences	P,O	15-Jun-07	Provides for the treatment of pulmonary arterial hypertension (WHO Group I) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
	N022128	Selzentry	maraviroc	Pfizer	P	06-Aug-07	Provides for the treatment of patients infected with CCR5-tropic HIV-1.
	N022119	Ammonia N13	ammonia	Feinstein	S	23-Aug-07	Provides for the treatment as a radioactive diagnostic agent for Positron Emission Tomography (PET), for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.
	N022074	Somatuline Depot	lanreotide	Biomeasure	S,O	30-Aug-07	Provides for the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy.
	N022106	Doribax	doripenem	Johnson & Johnson	S	12-Oct-2007	Provides for the treatment of complicated intra-abdominal (cIAI) and complicated urinary tract (eUTI) infections caused by susceptible isolates of the designated microorganisms.
	N022145	Isentress	raltegravir potassium	Merck	P	12-Oct-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
	N022065	Ixempra	ixabepilone	Bristol-Myers Squibb	P	16-Oct-2007	Provides in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. The new drug also provides as monotherapy for the treatment of matastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
	N022068	Tasigna/タシグナ(R)※[日]ノバルティス申請2007.6.26	nilotinib	Novartis	S,O	29-Oct-2007	(メシル酸イマチニブに抵抗性又は不耐容の慢性骨髄性白血病) Provides for the treatment of chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myelogenous leukemia (CML) in adult patients resistant to or intolerant to prior therapy that included Gleevec (imatinib).
	N022181	Kuvan	sapropterin dihydrochloride	BioMarin	P,O	13-Dec-2007	Provides for the reduction of blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).
	N021742	Bystolic	nebivolol	Mylan Bertek	S	17-Dec-2007	Provides for the treatment of hypertension alone or in combination with other antihypertensive agents.
	★BLA承認
	BL125166	Soliris※[日]未	eculizumab	Alexion	P,O	16-Mar-07	(夜間発作性血色素尿症の治療)Provides for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis.
	BL125164	Mircera	methoxy polyethylene glycol-epoetin beta	Hoffman La-Roche	S	14-Nov-07	Provides for the treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis.
●NME Drug and New Biologic Approvals in 2006
ML	NDA Number	Proprietary Name	Established Name	Applicant	分類	承認日	適応症
	N021938	Sutent/スーテントカプセル12.5mg※[日]ファイザー発売2008.6.13	sunitinib malate	Pfizer	P	26-Jan-06	(消化管間質腫瘍)N021938, Sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. Concurrently, N021668 Stutent, was also approved and and is indicated for the treatment of advanced renal cell carcinoma.
	N021526	Ranexa	ranolazine	CV Therap	S	27-Jan-06	Ranexa is indicted for the treatment of chronic angina. Because Ranexa prolongs the QT interval, it should be reserved for patients who have not achieved an adequate response with other antianginal drugs.
	N021908	Amitiza	lubiprostone	Sucampo ※武田：米・加販売権取得、欧州オプション	S	31-Jan-06	Amitiza is indicated for the treatment of chronic idiopathic constipation in the adult population.
	N021632	Eraxis	anidulafungin	Vicuron	S	17-Feb-06	N021632, Eraxis is indicated for the treatment of patients with esophageal candidiasis. Concurrently, N021948 Eraxis, was also approved and is indicated for the treatment of patients with candidemia and other forms of Candida infections (intra-abdominal abscess and peritonitis).
	N021790	Dacogen	decitabine	MGI Pharma	S, O	02-May-06	Provides for the treatment of myelodysplastic syndrome (MDS).
	N021928	Chantix	varenicline	Pfizer	P	10-May-06	Provides for use as an aid to smoking cessation.
	N021641	Azilect	rasagiline mesylate	Teva	S	16-May-06	Provides for the treatment of the signs and symptoms of idiopathic Parkinson's disease as initial monotherapy and as adjunct therapy to levodopa.
	N021976	Prezista	darunavir	Tibotec	P	23-Jun-06	When coadministered with 100 mg of ritonavir, provides for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
	N021986	Sprycel※[日]BMS申請中	dasatinib	Bristol-Myers Squibb	P, O	28-Jun-06	（慢性骨髄性白血病）Provides for the treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib.
	N021502	Anthelios SX	avobenzone; ecamsule; octocrylene	L'Oreal	S	21-Jul-06	Provides for the prevention of sunburn and to help provide protection from UVA and UVB rays.
	N022003	Noxafil	posaconazole	Schering	P	15-Sep-06	Provides for the treatment of prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with Graft versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
	N050786	Pylera	biskalcitrate; metronidazole; tetracycline hydrochloride	Axcan Scandipharm	S	28-Sep-06	Provides for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
	N021991	Zolinza	vorinostat	Merck	P,O	06-Oct-06	Provides for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
	N021995	Januvia	sitagliptin phosphate	Merck	S	16-Oct-06	Provides for the use as an adjunct to diet and exercise to improve gylcemic control in patients with type 2 diabetes mellitus as monotherapy and in combination with metformin or a PPARγ agonist (e.g., thiazolidinediones) when diet and excercise plus the single agent do not provide adequate glycemic control.
	N022004	Omnaris	ciclesonide	Altana	S	20-Oct-06	Provides for the treatment of seasonal and allergic rhinitis in patients 12 years of age and older.
	N022011	Tyzeka	telbivudine	Idenix	S	25-Oct-06	Provides for the treatment of chronic hepatitis B (CHB) in patients with evidence of viral replication and active liver inflammation.
	N021902	Veregen	kunecatechins	MediGene	S	31-Oct-06	Provides for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
	N021999	Invega	paliperidone	Janssen, L.P.	S	19-Dec-06	Provides for the treatment of schizophrenia.
	★BLA承認
	BL125141	Myozyme	alglucosidase alfa	Genzyme	P, O	28-Apr-06	Provides for the treatment of Pompe disease (GAA deficiency).
	BL125156	Lucentis/ルセンティス(R)※[日]ノバルティス申請2007.10.17	ranibizumab	Genentech	P	30-Jun-06	(加齢黄斑変性)Provides for the treatment of patients with neovascular (wet) age-related macular degeneration.
	BL125151	Elaprase	idursulfase	Shire Human Genetic Therapies	P, O	24-Jul-06	Provides for the treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
	BL125147	Vectibix※[日]武田薬品申請2008.6.30	panitumumab	amgen	P	27-Sep-06	(進行・再発の結腸・直腸癌)Provides for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy regimens.
●NME Drug and New Biologic Approvals in 2005
ML	NDA Number	Proprietary Name	Established Name	Applicant	分類	承認日	適応症
1209	N021332	Symlin	Pramlintide Acetate	Amylin	S	16-Mar-05	Symlin is indicated for: (1) Type 1 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. (2) Type 2 diabetes, as an adjunct treatment in patients who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy, with or without a concurrent sulfonylurea agent and/or metformin.
1211	N021506	Mycamine	Micafungin Sodium	Fujisawa 日本：発売	P	16-Mar-05	Mycamine is indicated for prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
1210	N021797	Baraclude	Entecavir	Bristol Myers Squibb 日本：BMS申請中	P	29-Mar-05	Baraclude is indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease.
1210	N021773	Byetta	Exenatide	Amylin	S	28-Apr-05	Byetta is indicated to improve glycemic control in patients with type 2 diabetes mellitus who have not achieved adequate glycemic control on metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea.
1217	N021821	Tygacil	Tigecycline	Wyeth Pharms 日本・ワイス P1	P	15-Jun-05	Tygacil is indicated for the treatment of Complicated Skin and Skin Structure Infections (cSSSI) and Complicated Intra-abdominal Infections (cIAI).
	N021536	Levemir	Insulin Detemir	Novo Nordisk 日本はノボが申請	S	16-Jun-05	Levemir is indicated for once or twice-daily subcutaneous administration in the treatment of adult patients with Type 1 or Type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
1219	N021814	Aptivus	Tipranavir	Boehringer Ingelheim 日本ベーリンガーインゲルハイムで開発検討中	P	22-Jun-05	Aptivus co-administered with 200 mg of ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors.
1221	N021782	Rozerem	Ramelteon	Takeda Global 日本P3	S	22-Jul-05	Rozerem is indicated for the treatment of insomnia characterized by difficulty with sleep onset.
	N021862	Nevanac	Nepafenac	Alcon	P	19-Aug-05	Nevanac is indicated for the treatment of pain and inflammation associated with cataract surgery.
	N021839	Increlex	Mecasermin (rDNA origin)	Tercica	P, O	30-Aug-05	Increlex is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.
	N021716	Hydase	Hyaluronidase	PrimaPharm	P	25-Oct-05	Hydase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
	N021877	Arranon	Nelarabine	GlaxoSmithKline ※GSK申請準備中	P, O	28-Oct-05	Arranon is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
	N021882	Exjade	Deferasirox	Novartis	P, O	02-Nov-05	Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older
	N021859	Hylenex	Recombinant Hyaluronidase	Human Halozyme	P	02-Dec-05	Hylenex recombinant is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
	N021884	Iplex	Mecasermin Rinfabate [rDNA Origin]	Insmed	P, O	12-Dec-05	Iplex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.
	N021923	Nexavar/ネクサバール	Sorafenib Tosylate	Bayer ※バイエル薬品発売2008.4.18	P, O	20-Dec-05	(腎細胞癌)Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma.
	N021880	Revlimid	Lenalidomide	Celgene	P, O	27-Dec-05	Revlimid is indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities.
	N021697	Vaprisol	Conivaptan Hydrochloride	Astellas	S	29-Dec-05	Vaprisol is indicated for the treatment of euvolemic hyponatremia in hospitalized patients
	★BLA承認
	BL125117	Naglazyme	Galsulfase	Biomarin Pharmaceutical Inc.	P, O	31-May-05	Treatment of patients with Mucopolysaccharidosis VI (MPS VI)
1229	BL125118	Orencia	Abatacept	Bristol-Myers Squibb ※[日]BMS 申請2008.9.18	P	23-Dec-05	(関節リウマチ)Abatacept is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease Modifying Anti-Rheumatoid Drugs (DMARDs), such as methotrexate or TNF antagonists. Abatacept may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists
●NME Drug and New Biologic Approvals in 2004
1183	N021395	Spiriva Handihaler	Tiotropium Bromide	Boehringer Ingelheim ※日本：申請	S	30-Jan-04	Spiriva HandiHaler is indicated for the long-term, once-daily, maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
1180	N021462	Alimta	Pemetrexed Disodium	Eli Lilly ※リリー	P, O	04-Feb-04	(悪性胸膜中皮腫、非小細胞肺癌)Alimta is indicated in the treatment of patients with malignant pleural mesothelioma whose disease is either unresectable or who are otherwise not candidates for curative surgery.
1192	N021688	Sensipar	Cinacalcet Hydrochloride	Amgen ※キリン	P, O	08-Mar-04	[二次性副甲状腺機能亢進症]Sensipar is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, and the treatment of hypercalcemia in patients with parathyroid carcinoma.
1189	N021144	Ketek	Telithromycin	Aventis Pharms ※ケテック錠	S	01-Apr-04	Ketek is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below, for patients 18 years old and above. (1) Acute bacterial exacerbation of chronic bronchitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis. (2) Acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis or Staphylococcus aureus. (3) Community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae (including multi-drug resistant Streptococcus pneumoniae [MDRSP] strains), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae.
	N021256	ChiRhoStim	Human Secretin	Chirhoclin	P	09-Apr-04	ChiRhoStim is indicated for (1) Stimulation of pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction, (2) Stimulation of gastrin secretion to aid in the diagnosis of gastrinoma, and (3) Stimulation of pancreatic secretions to facilitate the identification of the ampulla of Vater and accessory papilla during endoscopic retrograde cholangiopancreatography (ERCP).
	N021629	Apidra	Insulin Glulisine	Aventis Pharms	S	16-Apr-04	Apidra is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia.
1200	N021264	Apokyn	Apomorphine Hydrochloride	Bertek	P, O	20-Apr-04	Apokyn is indicated for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease.
	N021640	Vitrase	Ovine Hyaluronidase	Ista Pharms	P	05-May-04	Vitrase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
1190	N021618	Tindamax	Tinidazole	Presutti Labs	S	17-May-04	Tindamax is indicated for the treatment of trichomoniasis.
1201	N050794	Vidaza	Azacitidine	Pharmion	P, O	19-May-04	(骨髄異形成症候群)Vidaza is indicated for the treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia and requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia.
1191	N021361	Xifaxan	Rifaximin	Salix Pharma	S	25-May-04	Xifaxan is indicated for the treatment of patients (> 12 years of age) with travelers' diarrhea caused by noninvasive strains of Escherichia coli. Xifaxan should not be used in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli.
1188	N021595	Sanctura	Trospium Chloride	Indevus ※スパスメックス錠[日研]	S	28-May-04	Sanctura is indicated for the treatment of overactive bladder associated with symptoms of urge urinary incontinence, urgency, and urinary frequency.
	N021667	NutreStore	L-Glutamine	Nutritional Restart	S, O	10-Jun-04	NutreStore is indicated for the treatment of short bowel syndrome in patients receiving specialized nutritional support when used in conjunction with a recombinant human growth that is approved for this indication.
1199	N021431	Campral	Acamprosate Calcium	Lipha ※日本新薬	P	29-Jul-04	Campral is indicated for the maintenance of abstinence from alcohol in patients with alcohol dependence who are abstinent at treatment initiation.
1193	N021427	Cymbalta	Duloxetine Hydrochloride	Eli Lilly ※塩野義P3	S	03-Aug-04	Cymbalta is indicated for the treatment of major depressive disorder (MDD).
	N021749	Pentetate Calcium Trisodium	Pentetate Calcium Trisodium	Pharma Hameln GmbH	P, O	11-Aug-04	Pentetate Calcium Trisodium is indicated for the treatment of internal contamination with plutonium, americium or curium to increase the rates of elimination.
	N021751	Pentetate Zinc Trisodium	Pentetate Zinc Trisodium	Pharma Hameln GmbH	P, O	11-Aug-04	Pentetate Zinc Trisodium is indicated for the treatment of internal contamination with plutonium, americium or curium to increase the rates of elimination.
1228	N021468	Fosrenol	Lanthanum Carbonate Hydrate	Shire Pharm ※バイエル薬品P2	S	26-Oct-04	(末期腎疾患での抗リン血症治療薬)Fosrenol is indicated to reduce serum phosphate in patients with end stage renal disease.
	N021665	Amphadase	Hyaluronidase	Amphastar Pharm	P	26-Oct-04	Amphadase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as as adjunct in subcutaneous urography for improving resorption of radiopaque agents.
1221	N021654	Omacor	Omega-3-acid Ethyl Esters	Ross Prods	S	10-Nov-04	Omacor is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with TG levels > 500 mg/dL.
1205	N021743	Tarceva/タルセバ(R)錠	Erlotinib Hydrochloride	OSI Pharms ※中外製薬発売2007.12.18	P	18-Nov-04	(非小細胞肺がん)Tarceva is indicated for the treatment of locally advanced or metastatic Non Small-Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapy regimen.
1204	N021518	VESIcare	Solifenacin Succinate	Yamanouchi ※アステラス申請	S	19-Nov-04	VESIcare is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency.
	N021357	Multihance	Gadobenate Dimeglumine	Bracco	S	23-Nov-04	Multihance is indicated for intravenous use in magnetic resonance imaging (MRI) of the CNS in adults to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine, and associated tissues.
1203	N021476	Lunesta	Eszopicline	Sepracor	S	15-Dec-04	Lunesta is indicated for the treatment of insomnia.
	N021670	Vision Blue	Trypan Blue	Dorc International BV	P	16-Dec-04	Visionblue is indicated as an aid in ophthalmic surgery by staining the anterior capsule of the lens.
1212	N021756	Macugen/マクジェン硝子体内注射用キット0.3mg	Pegaptanib Sodium	Eyetech Pharms [日]ファイザー発売2008.10.14	P	17-Dec-04	(中心窩下脈絡新生血管を伴う加齢黄斑変性症)Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.
1204	N021513	Enablex	Darifenacin Hydrobromide	Novartis ※ファイザーP2中止	S	22-Dec-04	Enablex is indicated for the treatment of overactive bladder.
	N021060	Prialt	Ziconotide	Elan Pharms [EU]エーザイ	P	28-Dec-04	Prialt is indicated for the management of severe chronic pain in patients for whom intrathecal (IT) therapy is warranted and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or IT morphine.
	N021673	Clolar	Clofarabine	Genzyme	P, O	28-Dec-04	Clolar is indicated for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens.
	N021779	Ventavis	Iloprost	Cotherix	P, O	29-Dec-04	Ventavis is indicated for the treatment of pulmonary arterial hypertension.
1217	N021446	Lyrica	Pregabalin	Pfizer	P	30-Dec-04	Lyrica is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy.
	★BLA承認
1184	BL125084	Erbitux/アービタックス(R)	Cetuximab	ImClone Systems ※[日]BMS&メルクセローノ発売2008.9.19	P	12-Feb-04	(結腸・直腸癌)Erbitux is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan); Treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy (administered as a single agent).
1184	BL125085	Avastin/アバスチン(R)点滴静注用100mg/４mL、同400mg/16mL	Bevacizumab	Genentech ※[日]中外発売2007.6.11	P	26-Feb-04	(大腸がん)Avastin is indicated for the first-line treatment of patients with metastatic carcinoma of the colon and rectum (in combination with intravenous 5-fluorouracil-based chemotherapy).
	BL103928	NeutroSpec※[日]未	Technetium 99m Tc Fanolesomab	Palatin Technologies	S	02-Jul-04	(急性虫垂炎の診断)NeutroSpec is indicated for scintigraphic imaging of patients with equivocal signs and symptoms of appendicitis who are five years of age or older.
1202 1204	BL125104	Tysabri	Natalizumab	Biogen Idec Inc.	P	23-Nov-04	(多発性硬化症)Tysabri is indicated in the treatment of patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations.
1207	BL125103	Kepivance	Palifermin	Amgen, Inc.	P	15-Dec-04	Kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support.

●NME Drug and New Biologic Approvals in 2003
ML	NDA Number	Generic Name	Trade Name	Dosage Form	Applicant	分類	Approval Date
1159	21481	Enfuvirtide	Fuzeon	Injectable	Roche	1P	03-13-03
1160	21106	Pegvisomant	Somavert	Injectable	Pharmacia and Upjohn	1PV	03-25-03
1162	21549	Aprepitant	Emend	Capsule	Merck	1P	03-26-03
1192	21158	Gemifloxacin Mesylate	Factive	Tablet	LG Life	1S	04-04-03
1138	21399	Gefitinib	Iressa	Tablet	AstraZeneca	1P	05-05-03
1161	21602	Bortezomib	Velcade	Injectable	Millennium Pharms	1P	05-13-03
1207	21455	Ibandronate Sodium	Boniva	Tablet	Roche	1S	05-16-03
1173	21287	Alfuzosin Hydrochloride	Uroxatral	Tablet	Sanofi-Synthelabo	1S	06-12-03
1169	21567	Atazanavir Sulfate	Reyataz	Capsule	Bristol Myers Squibb	1P	06-20-03
1169	21500	Emtricitabine	Emtriva	Capsule	Gilead	1S	07-02-03
1179	21372	Palonosetron Hydrochloride	Aloxi	Injection	Helsinn Hlthcare	1S	07-25-03
	21348	Miglustat	Zavesca	Capsule	Actelion Pharms	1SV	07-31-03
1167	21366	Rosuvastatin Calcium	Crestor	Tablet	IPR	1S	08-12-03
1166	21400	Vardenafil Hydrochloride	Levitra	Tablet	Bayer	1S	08-19-03
1175	21572	Daptomycin	Cubicin	Injectable	Cubist Pharms	1P	09-12-03
	21626	Prussian Blue	Radiogardase	Capsule	Heyl Chemisch- pharmazeutische Fabrik GmbH	1PV	10-02-03
	21487	Memantine Hydrochloride	Namenda	Tablet	Forest Labs	1S	10-16-03
	21565	Epinastine Hydrochloride	Elestat	Solution	Allergan	1S	10-16-03
1172	21368	Tadalafil	Cialis	Tablet	Lilly Icos	1S	11-21-03
1178	21320	Abarelix	Plenaxis	Injectable	Praecis	1P	11-25-03
	21385	Sertaconazole Nitrate	Ertaczo	Cream	Mylan Pharms	1S	12-10-03
●NME Drug and New Biologic Approvals in 2002
ML	NDA Number	Generic Name	Trade Name	Dosage Form	Applicant	分類	Approval Date
	21-232	Nitisinone	Orfadin	Capsule	Swedish Orphan	1PV	01-18-2002
1136	21-286	Olmesartan Medoxomil	Benicar	Tablet	Sankyo	1S	04-25-2002
1135	21-344	Fulvestrant	Faslodex	Injection	AstraZeneca	1S	04-25-2002
1139	21-272	Treprostinil Sodium	Remodulin	Injection	United Therapeutics	1PV	05-21-2002
1135	21-266	Voriconazole	VFEND	Tablet	Pfizer	1S	05-24-2002
	21-191	Dimyristoylphosphatidylcholine/ Perflexane	Imagent Kit for the Preparation of Perflexane Lipid Microspheres	Injectable Suspension	Alliance Pharm	1S	05-31-02
1145	21-196	Sodium Oxybate	Xyrem	Solution	Orphan Medical	1PV	07-17-02
1139	21-200	Tegaserod Maleate	Zelnorm	Tablet	Novartis Pharms	1P	07-24-02
1148	21-492	Oxaliplatin	Eloxatin	Injection	Sanofi	1P	08-09-02
1145	21-449	Adefovir Dipivoxil	HEPSERA	Tablet	Gilead Sciences	1P	09-20-02
1156	21-437	Eplerenone	Inspra	Tablet	GD Searle	1S	09-27-02
1151	21-445	Ezetimibe	Zetia	Tablet	MSP Singapore	1S	10-25-02
1150	21-436	Aripiprazole	Abilify	Tablet	Otsuka	1S	11-15-02
1154	21-498	Nitazoxanide	Alinia	Suspension	Romark	1PV	11-22-02
1149	21-411	Atomoxetine HCl	Strattera	Capsule	Lilly	1S	11-26-02
	21-321	Icodextrin	Extraneal	Solution	Baxter Healthcare	1SV	12-20-02
1155	21-016	Eletriptan Hydrobromide	Relpax	Tablet	Pfizer	1S	12-26-02
●NME Drug and New Biologic Approvals in 2001
ML	NDA Number	Generic Name	Trade Name	Dosage Form	Applicant	分類	Approval Date
1108	21-227	Caspofungin Acetate	Cancidas	Injection	Merck Res	1P	01-26-2001
1106	20-825	Ziprasidone HCl	Geodon	Capsule	Pfizer Medicinal	1S	02-05-2001
1104	20-831	Formoterol Fumarate	Foradil Aerolizer	Capsule, Inhalation Powder	Novartis Pharms	1S	02-16-2001
1107	21-169	Galantamine Hydrobromide	Reminyl	Tablet	Janssen Res Foundation	1S	02-28-2001
	21-257	Travoprost	Travatan	Solution	Alcon Universal	1P	03-16-2001
	21-275	Bimatoprost	Lumigan	Solution	Allergan	1P	03-16-2001
1124	21-001	Almotriptan Malate	Axert	Tablet	Pharmacia & Upjohn	1S	05-07-2001
1106	21-335	Imatinib Mesylate	Gleevec	Capsule	Novartis Pharms	1PV	05-10-2001
1133 配	21-098	Drospirenone/Ethinyl Estradiol	Yasmin	Tablet	Berlex Labs	1,4S	05-11-2001
	21-064	Perflutren Lipid Microsphere	Definity	Injectable	Dupont Pharms	1S	07-31-2001
1118	20-920	Nesiritide	Natrecor	Injectable	Scios	1S	08-10-2001
1120	21-223	Zoledronic Acid	Zometa	Injectable	Novartis	1P	08-20-2001
1122	21-222	Cefditoren Pivoxil	Spectracef	Tablet	Tap Pharm	1S	08-29-2001
配	21-187	Ethinyl Estradiol/Etonogestrel	NuvaRing	Vaginal Ring	Organon	1,4S	10-03-2001
	21-356	Tenofovir Disoproxil Fumarate	Viread	Tablet	Gilead Sciences	1P	10-26-2001
1124	21-006	Frovatriptan	Frova	Tablet	Elan Pharms	1S	11-08-2001
1129	21-341	Valdecoxib	Bextra	Tablet	Searle Pharms	1S	11-16-2001
1122 配	21-180	Ethinyl Estradiol/Norelgestromin	Ortho Evra	Transdermal System (Contraceptive Patch)	RW Johnson	1,4S	11-20-2001
1127	21-290	Bosentan	Tracleer	Tablet	Actelion	1SV	11-20-2001
1146	21-319	Dutasteride	Trade Name-Pending ※Avodart	Soft-Gelatin Capsule	GlaxoSmithKline	1S	11-20-2001
1126	21-337	Ertapenem Sodium	Invanz	Injectable	Merck	1S	11-20-2001
1130	21-345	Fondaparinux Sodium	Arixtra	Injectable	Fonda BV	1P	12-07-2001
1131	21-302	Pimecrolimus	Elidel	Cream	Novartis Pharms	1S	12-13-2001
1126	21-165	Desloratadine	Clarinex	Tablet	Schering	1S	12-21-2001
●NME Drug and New Biologic Approvals in 2000
ML	NDA Number	Generic Name	Trade Name	Dosage Form	Applicant	分類	Approval Date
1084	20-989	Cevimeline HCl	Evoxac	Capsule	Snowbrand	1S	01-11-2000
1076	21-014	Oxcarbazepine	Trileptal	Tablet	Novartis Pharms	1S	01-14-2000
1083	20-987	Pantoprazole Sodium	Protonix	Tablet	Wyeth Ayerst	1S	02-02-2000
1081	21-107	Alosetron HC1	Lotronex	Tablet	Glaxo Wellcome	1P	02-09-2000
	21-084	Perfluoroalkylpolyether; (PFPE) Polytetrafluoroethylene (PTFE)	Skin Exposure Reduction Paste Against Chemical Warfare Agents (SERPACWA)	Paste	US Army Med Res and Material Command	1,4P	02-17-2000
1089	20-789	Zonisamide	Zonegran	Capsule	Elan Pharms	1S	03-27-2000
配	20-971	Articaine HCl 4%; Epinephrine	Septocaine	Injectable	Deproco	1,4S	04-03-2000
1086	21-119	Verteporfin	Visudyne	Injectable	QLT PhotoTherapeutics	1P	04-12-2000
1079	20-938	Meloxicam	Mobic	Tablet	Boehringer Pharms	1S	04-13-2000
1079	21-130	Linezolid	Zyvox	Tablet	Pharmacia and Upjohn	1P	04-18-2000
1110	21-081	Insulin Glargine	Lantus	Injectable	Aventis Pharms	1S	04-20-2000
1089	20-823	Rivastigmine Tartrate	Exelon	Capsule	Novartis Pharms	1S	04-21-2000
1083	21-174	Gemtuzumab Ozogamicin	Mylotarg	Injectable	Wyeth Ayerst	1PV	05-17-2000
1091	21-176	Colesevelam HCl	Welchol	Tablet	GelTex	1S	05-26-2000
1115	20-986	Insulin Aspart Recombinant	NovoLog	Injectable	Novo Nordisk	1S	06-07-2000
1132	20-715	Triptorelin Pamoate	Trelstar Depot	Injectable	Debio Recherche	1S	06-15-2000
1097	20-883	Argatroban	Acova	Injectable	Texas Biotech	1S	06-30-2000
1098	20-484	Tinzaparin Sodium	Innohep	Injectable	Dupont Pharms	1S	07-14-2000
1109	20-610	Balsalazide Disodium	Colazal	Capsule	Salix Pharms	1S	07-18-2000
1092	20-941	Docosanol	Abreva	Cream	Avanir Pharm	1S	07-25-2000
	21-214	Unoprostone Isopropyl	Rescula	Solution	Ciba Vision	1P	08-03-2000
	21-197	Cetrorelix Acetate	Cetrotide	Injectable	Asta Medica	1S	08-11-2000
1095 配	21-226	Lopinavir;Ritonavir	Kaletra	Capsule	Abbott Labs	1,4P	09-15-2000
	21-248	Arsenic Trioxide	Trisenox	Injectable	Cell Therapeutics	1PV	09-25-2000
1091	20-687	Mifepristone	Mifeprex	Tablet	Population Council	1P	09-28-2000
1103	20-873	Bivalirudin	Angiomax	Injectable	The Medicines Co	1S	12-15-2000
1101	21-204	Nateglinide	Starlix	Tablet	Novartis	1S	12-22-2000
●NME Drug and New Biologic Approvals in 1999
ML	NDA Number	Generic Name	Trade Name	Dosage Form	Applicant	分類	Approval Date
1052	20-863	Cilostazol	Pletal	Tablet	Otsuka Pharm	1S	01-15-1999
	20-886	Alitretinoin	Panretin	Topical Gel	Ligand Pharm	1-PV	02-02-1999
	20-955	Sodium Ferric Gluconate Complex	Ferrlicit	Injectable	R&D Labs	1P	02-18-1999
1057	21-007	Amprenavir	Agenerase	Capsule	Glaxo Wellcome	1P	04-15-1999
1055	20-766	Orlistat	Xenical	Capsule	Roche	1P	04-23-1999
1056	21-042	Rofecoxib	Vioxx	Tablet	Merck Res	1P	05-20-1999
1059	21-071	Rosiglitazone Maleate	Avandia	Tablet	SKB Pharms	1P	05-25-1999
	20-862	Doxercalciferol	Hectorol	Capsule	Bone Care	1S	06-09-1999
1077	21-066	Ketotifen Fumarate	Zaditor	Solution	Ciba Vision	1P	07-02-1999
1066	21-073	Pioglitazone HCl	Actos	Tablet	Takeda America	1P	07-15-1999
1063	21-036	Zanamivir	Relenza	Powder for Inhalation	Glaxo Wellcome	1P	07-26-1999
	21-057	Ganirelix Acetate	Antagon	Injectable	Organon	1P	07-29-1999
	21-012	Kit for the Prep Technetium TC 99M Depreotide	Technetium TC 99M Depreotide Kit	Injectable	Diatide	1P	08-03-1999
1068	21-029	Temozolomide	Temodar	Capsule	Schering	1PV	08-11-1999
1063	20-859	Zaleplon	Sonata	Capsule	Wyeth Ayerst Labs	1S	08-13-1999
	20-984	Rapacuronium Bromide	Raplon	Injection	Organon	1S	08-18-1999
1066	20-973	Rabeprazole Sodium	Aciphex	Tablet	Eisai (US)	1S	08-19-1999
1071	21-083	Sirolimus	Rapamune	Solution	Wyeth Ayerst Labs	1P	09-15-1999
1071	50-778	Epirubicin HCl	Ellence	Injectable	Pharmacia and Upjohn	1P	09-15-1999
1066 配	50-747	Dalfopristin/Quinupristin	Synercid	Injectable	Rhone Poulenc Rorer	1P	09-21-1999
1077	21-079	Pemirolast Potassium	Alamast	Solution	Santen	1P	09-24-1999
1078	20-931	Dofetilide	Tikosyn	Capsule	Pfizer	1S	10-01-1999
1070	20-796	Entacapone	Comtan	Tablet	Orion	1S	10-19-1999
1076	20-753	Exemestane	Aromasin	Tablet	Pharmacia & Upjohn	1SV	10-21-1999
1063	21-087	Oseltamivar Phosphate	Tamiflu	Capsule	Roche	1P	10-27-1999
1074	20-744	Poractant	Curosurf	Suspension	Dey Labs	1SV	11-18-1999
1076	21-035	Levetiracetam	Keppra	Tablet	UCP Pharma	1S	11-30-1999
1133	20-965	Aminolevulinic Acid HCl	Levulan Kerastick	Solution	Dusa	1S	12-03-1999
	20-937	Gadoversetamide	Optimark	Injectable	Mallinckrodt	1S	12-08-1999
配	20-922	Mequinol; Tretinoin	Solage	Solution	Bristol Myers Squibb	1S	12-10-1999
1072	21-085	Moxifloxacin HCl	Avelox	Tablet	Bayer	1S	12-10-1999
	21-038	Dexmedetomidine HCl	Precedex	Injectable	Abbott Labs	1S	12-17-1999
1072	21-061	Gatifloxacin	Tequin	Tablet	Bristol Myers Squibb	1S	12-17-1999
	20-845	Nitric Oxide	INOmax	Gas for Inhalation	INO Thereapeutics	1PV	12-23-1999
1075	21-055	Bexarotene	Targretin	Capsule	Ligand Pharms	1PV	12-29-1999
●New Molecular Entities (NMEs) Approved in Calendar Year 1998
ML	NDA Number	Generic Name	Trade Name	Dosage Form	Applicant	分類	Approval Date
1028	20-697	Tolcapone	Tasmar	Tablet	Roche	1-S	01-29-1998
1037	20-763	Naratriptan HCl	Amerge	Tablet	Glaxo Wellcome	1-S	02-10-1998
1031	20-829	Montelukast Sodium	Singulair	Tablet	Merck	1-S	02-20-1998
1036	20-807	Lepirudin	Refludan	Powder	Hoechst Marion Roussel	1-PV	03-06-1998
	20-583	Loteprednol Etabonate	Lotemax	Ophthalmic Suspension	Bausch & Lomb	1-S	03-09-1998
1038	20-771	Tolterodine Tartrate	Detrol	Tablet	Pharmacia & Upjohn	1-S	03-25-1998
1034	20-835	Risedronate Sodium	Actonel	Tablet	Procter & Gamble	1-S	03-27-1998
1026	20-895	Sildenafil Citrate	Viagra	Tablet	Pfizer	1-P	03-27-1998
1036	20-816	Brinzolamide	Azopt	Ophthalmic Suspension	Alcon	1-S	04-01-1998
	20-772	Sacrosidase	Sucraid	Solution	Orphan Medical	1-PV	04-09-1998
	20-819	Paricalcitol	Zemplar	Injection	Abbott	1-S	04-17-1998
1039	20-896	Capecitabine	Xeloda	Tablet	Roche	1-P	04-30-1998
1035	20-912	Tirofiban HCl	Aggrastat	Injection	Merck	1-P	05-14-1998
1035	20-718	Eptifibatide	Integrilin	Injection	COR Therapeutics	1-P	05-18-1998
1040	20-838	Candesartan Cilexetil	Atacand	Tablet	Astra Merck	1-S	06-04-1998
1047	21-024	Rifapentine	Priftin	Tablet	Hoechst Marion Roussel	1-PV	06-22-1998
1037	20-864	Rizatriptan Benzoate	Maxalt	Tablet	Merck	1-S	06-29-1998
1038	20-785	Thalidomide	Thalomid	Capsule	Celgene	1-PV	07-16-1998
1041	20-822	Citalopram Hydrobromide	Celexa	Tablet	Forest Pharms	1-S	07-17-1998
	20-961	Fomivirsen Sodium	Vitravene	Injection	Isis Pharm	1-P	08-26-1998
1040	20-905	Leflunomide	Arava	Tablet	Quintiles	1-P	09-10-1998
	20-887	Technetium tc 99m Apcitide	AcuTect	Injection	Diatide	1-P	09-14-1998
1041	20-972	Efavirenz	Sustiva	Capsule	Dupont Pharm	1-P	09-17-1998
1049	20-892	Valrubicin	Valstar	Solution	Anthra Pharm	1-PV	09-25-1998
	20-926	Sevelamer HCl	Renagel	Capsule	GelTex Pharm	1-S	10-30-1998
1065	20-850	Telmisartan	Micardis	Tablet	Boehringer Ingelheim	1-S	11-10-1998
	20-898	Thyrotropin Alfa	Thyrogen	Injection	Genzyme	1-PV	11-30-1998
1041	20-977	Abacavir Sulfate	Ziagen	Tablet	Glaxo Wellcome	1-P	12-17-1998
1049	20-717	Modafinil	Provigil	Tablet	Cephalon	1-SV	12-24-1998
1045	20-998	Celecoxib	Celebrex	Capsule	Searle	1-P	12-31-1998

■Priority NDA and BLA Approvals

NDA Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New formulation
4 -   New combination
5 -   New manufacturer
7 -   Drug already marketed, but without an approved NDA

Review Classification:  
P -   Priority Review - 優先処理
Significant improvement compared to marketed products,
 in the treatment, diagnosis, or prevention of a disease.
O -  Orphan Designation - オーファン指定
Pursuant to Section 526 of the Orphan Drug Act
 (Public Law 97-414 as amended).


●CDER Priority NDA and BLA Approvals in 2009

[-2009.6.30迄]

 
CDER Priority Drug and Biologic Approvals in Calendar Year 2009
Updated through June 30, 2009
Priority New Drug Application (NDA) Approvals:


NDA Number
Proprietary Name
PROPER Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
N022278
MEMBRANEBLUE
TRYPAN BLUE
蘭DORC INTERNATIONAL
5
P
20-Feb-09
PROVIDES FOR THE USE AS AN AID IN OPHTHALMIC SURGERY BY STAINING THE EPIRETINAL MEMBRANES DURING OPHTHALMIC SURGICAL VITRECTOMY PROCEDURES, FACILITATING REMOVAL OF THE TISSUE.[1)For use as an aid in ophthalmic posterior surgery(後眼房の手術);　2)Facilitating removal of epiretinal tissue.(網膜組織除去補助)]
N022334
AFFINITOR
EVEROLIMUS
NOVARTIS PHARMS
1
P
30-Mar-09
PROVIDES FOR TREATMENT OF ADVANCED RENAL CELL CARCINOMA
N022268
COARTEM
ARTEMETHER/ LUMEFANTRINE
NOVARTIS PHARMS
1
P,O
07-Apr-09
PROVIDES FOR TREATMENT OF INFECTIONS DUE TO PLASMODIUM FALCIPARUM OR MIXED INFECTIONS INCLUDING P.FALCIPARUM
N020725
CREON
PANCRELIPASE
SOLVAY PHARMS
7
P
30-Apr-09
PROVIDES FOR TREATMENT OF ADULT AND PEDIATRIC PATIENTS WITH EXOCRINE INSUFFICIENCY[for the treatment of exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF) or other conditions]
N022348
CALDOLOR
IBUPROFEN
CUMBERLAND PHARMS
5
P
11-Jun-09
PROVIDES FOR THE REDUCTION IN FEVER AND MANAGEMENT OF ACUTE PAIN
N022315
OZURDEX
DEXAMETHASONE BIODEGRADABLE INTRAVITREAL
ALLERGAN
3
P
17-Jun-09
PROVIDES FOR THE TREATMENT OF PATIENTS WITH MACULAR EDEMA SECONDARY TO CENTRAL RETINAL VEIN OCCULUSION OR BRANCH RETINAL VEIN OCCLUSION


New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):

NDA Number
Proprietary Name
Proper Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication


Priority Biologic License Application (BLA) Approvals:

BLA Number
Proprietary Name
Proper Name
Applicant
Review Classification
Approval Date
Indication
L 125319/0.0
CANAKINUMAB
ILARIS
NOVARTIS PHARMACEUTICALS CORPORATION
P
17-Jun-09
PROVIDES FOR THE TREATMENT OF CRYOPYRIN ASSOCIATED PERIODIC SYNDROME (CAPS) IN PEDIATRICS AND ADULTS

NDA Chemical Type:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent derivative
3 - New formulation
4 - New combination
5 - New manufacturer
7 - Drug already marketed, but without an approved NDA
Review Classification:
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).



●CDER Priority NDA and BLA Approvals in 2008

[-2008.12.31迄;最終更新2009.4.30]

CDER Priority Drug and Biologic Approvals in Calendar Year 2008
Updated through November 30, 2008
Priority New Drug Application (NDA) Approvals:

NDA Number
Proprietary Name
Established Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
N022187
Intelence
etravirine
Tibotec
1
P
18-Jan-08
Provides in combination with other antiretroviral agents for the the treatment of HIV-1 infection in treatment-experienced adult patients, who have evidence of viral replication and HIV-1 strains resistant to a non-nucleoside reverse transcriptase inhibitor (NNRTI) and other antiretroviral agents.
N022249
Treanda
bendamustine hydrochloride
Cephalon
1
P,O
20-Mar-08
Provides for the treatment of patients with chronic lymphocytic leukemia (CLL).
N021822
Aptivus
tipranavir
Boehringer Ingelheim
3
P
23-Jun-08
Provides for combination antiretroviral treatment of HIV-1 infected pediatric (age 2 to 18 years) patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.
N022212
Durezol
difluprednate
Sirion
1
P
23-Jun-08
Provides for the treatment of inflammation and pain associated with ocular surgery.
N022292
Aptivus
tipranavir
Boehringer Ingelheim
3
P
23-Jun-08
Provides for combination antiretroviral treatment of HIV-1 infected pediatric (age 2 to 18 years) patients who are treatment-experienced and infected with HIV-1 strains resistant to more than one protease inhibitor.
N021894
Xenazine
tetrabenazine
Prestwick
1
P
15-Aug-08
Provides treatment for the chorea of Huntington's Disease.
N022290
Adre View
iobenuane
GE Healthcare
1
P
19-Sep-08
Provides for the detection of primary or metastatic pheochromocytomas[褐色細胞腫].
N022291
Promacta
eltrombopag olamine
GlaxoSmithKline
1
P
20-Nov-08
Provides for the treatment of short term idiopathic thrombocytopaenic pupura (ITP)



New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):

NDA Number
Proprietary Name
Proper Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
NO21837
Stavudine;Lamivudine; Nevirapine
stavudine;lamivudine; nevirapine
Strides
4
P
20-Mar-08
Provides for the treatment of HIV-1 infection.
NO22177
Stavudine;Lamivudine; Nevirapine
stavudine;lamivudine; nevirapine
Strides
4
P
20-Mar-08
Provides for the treatment of HIV-1 infection
NO22167
Lamivudine;Stavudine
lamivudine;stavudine
Cipla Limited
3
P
19-Jun-08
Provides for the treatment of HIV-1 infection
NO22141
Tenofavir Disoproxyl Furmate/ Lamivudine
tenofavir disoproxyl furmate/ lamivudine
Matrix Labs
4
P
12-Sep-08
Provides for the treatment of HIV
NO22293
Abacavir Sulfate
abacavir sulfate
Aurobindo
3
P
12-Sep-08
Provides for the treatment of HIV-1 infection.


N021837 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR.
N022177 stavudine 30mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/20/2008 under PEPFAR.
N022167 lamivudine 30mg/stavudine 6mg Tablets was tentatively approved on 06/19/2008 under PEPFAR.
N022141 tenofavir disoproxyl furmate/lamivudine was tentatively approved on 09/12/2008 under PEPFAR.
N022293 acacavir sulfate 60mg tablets was tentatively approved on 09/12/2008 under PEPFAR.


Priority Biologic License Application (BLA) Approvals:

BLA Number
Proprietary Name
Proper Name
Applicant
Review Classification
Approval Date
Indication
125249
Arcalyst
rilonacept
Regeneron
P,O
27-Feb-08
Provides treatment for cryopyrin-associated periodic syndromes (CAPS).※Cryopyrin関連周期熱症候群(CAPS)


NDA Chemical Type:
1 - New molecular entity
2 - New ester, new salt, or other noncovalent derivative
3 - New formulation
4 - New combination
5 - New manufacturer
7 - Drug already marketed, but without an approved NDA
Review Classification:
P - Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a
O - Orphan Designation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).




●CDER Priority NDA and BLA Approvals in 2007

[-2007.12.31迄;最終更新2009.4.30]

Priority New Drug Application (NDA) Approvals:

NDA Number	Proprietary Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date	Indication
N022059	Tykerb	lapatinib	GlaxoSmithKline	1	P	13-Mar-07	Provides for the treatment of patients with advanced or metastatic breast cancer whose tumors over-express HER2 (ErbB2) and who have received prior therapy including and anthracycline, a taxane and trastuzumab.
N021817	Reclast	zoledronic acid	Novartis	3	P	16-Apr-2007	Provides for the treatment of Paget's disease of bone.
N022088	Torisel	temsirolimus	Wyeth	1	P,O	30-May-2007	Provides for the treatment of advanced renal cell carcinoma./※分子標的薬；m-TOR阻害薬/FDA承認2007.5.30/EU承認2007.11.26
N022116	Lexiva	fosamprenavir calcium	GlaxoSmithKline	3	P	14-Jun-2007	Provides for the treatment of HIV infection.
N022081	Letairis	ambrisentan	Gilead Sciences	1	P,O	15-Jun-2007	Provides for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
N022128	Selzentry	maraviroc	Pfizer	1	P	06-Aug-2007	Provides for the treatment of patients infected with CCR5-tropic HIV-1.
N022025	Totect	dexrazoxane	Alba BioPharm	5	P	06-Sep-2007	Provides for the treatment of extravasation resulting from IV anthracycline chemotherapy.※ドキソルビシン（アドリアマイシン）の心毒性を減少させる .
N020981	Hycamtin	topotecan	GlaxoSmithKline	3	P	11-Oct-2007	Provides for the treatment of relapsed small cell lung cancer in patients with prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.
N022145	Isentress	raltegravir pottassium	Merck	1	P	12-Oct-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
N022065	Ixempra	ixabepilone	Bristol-Myers Squibb	1	P	16-Oct-2007	Provides in combination with capecitabine for the treatment of patients with metastatic or locally advanced breast cancer resistant to treatment with an anthracycline and a taxane, or whose cancer is taxane resistant and for whom further anthracycline therapy is contraindicated. The new drug also provides as monotherapy for the treatment of matastatic or locally advanced breast cancer in patients whose tumors are resistant or refractory to anthracyclines, taxanes, and capecitabine.
N022048	Triesence	triamcinolone acetonide	Alcon	3	P	29-Nov-2007	Provides for the treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteriods. Also, is indicated for visualization during vitrectomy.
N022181	Kuvan	sapropterin dihydrochloride	BioMarin	1	P,O	13-Dec-2007	Provides for the reduction of blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU).

New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):

NDA Number	Proper Name	Established Name	Applicant	Chemical Type	Review Classification	Approval Date	Indication
N021974	lamivudine; stavudine	lamivudine; stavudine	Cipla Limited	4	P	19-Jan-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021939	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Aurobindo	4	P	29-Jan-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021971	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Cipla Limited	4	P	31-Jan-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021988	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Strides Arcolab	4	P	02-Mar-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021838	stavudine; lamivudine	stavudine; lamivudine	Strides Arcolab	4	P	13-Mar-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021854	stavudine; lamivudine; nevirapine	stavudine; lamivudine; nevirapine	Strides Arcolab	4	P	13-Mar-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022096	lamivudine; zidovudine; efavirenz	lamivudine; zidovudine; efavirenz	Strides Arcolab	3	P	01-Jun-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022097	lamivudine; stavidine; efavirenz	lamivudine; stavidine; efavirenz	Strides Arcolab	3	P	01-Jun-2007	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021972	lamivudine; stavudine; nevirapine	lamivudine;  stavudine; nevirapine	Cipla Limited	3,4	P	13-Aug-2007	Provides for use alone as a complete  regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022085	lamivudine; stavudine	lamivudine;  stavudine;	Matrix	4	P	02-Nov-2007	Provides for use alone as  in combination with other antiretroviral agents for the treatment of HIV-1 infection.

N021974 lamivudine 150mg/stavudine 30mg and  lamivudine 150mg/stavudine 40mg Tablets was tentatively approved on 01/19/2007 under PEPFAR.
N021988 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 01/29/2007 under PEPFAR.
N021971 lamivudine 150mg/zidovudine 300mg/nevirapine 200mg Tablets was tentatively approved on 01/31/2007 under PEPFAR.
N021988 lamivudine 300mg/zidovudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/02/2007 under PEPFAR.
N021838 stavudine 40mg/lamivudine 150mg Tablets was tentatively approved on 03/13/2007 under PEPFAR.
N021854 stavudine 40mg/lamivudine 150mg/nevirapine 200mg Tablets was tentatively approved on 03/13/2007 under PEPFAR.
N022096 lamivudine 150mg/zidovudine 300mg/efavirenz 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR.
N022097 lamivudine 150mg/stavidine 40mg/efavirenz 600mg Tablets was tentatively approved on 06/01/2007 under PEPFAR.
N021972 lamivudine 30mg/stavidine 6mg/nevirapine 50mg Tablets was tentatively approved on 08/13/2007 under PEPFAR.
N022145 Isentress 400 mg Tablets was approved on 10/12/2007 under PEPFAR.
N022085 lamivudine 150mg/stavidine 30mg Tablets was tentatively approved on 11/02/2007 under PEPFAR.

Priority Biologic License Application (BLA) Approvals:

BLA Number	Proprietary Name	Proper Name	Applicant	Review Classification	Approval Date	Indication
BL125166	Soliris	eculizumab	Alexion	P,O	16-Mar-2007	Provides for the treatment of paroxysmal nocturnal hemoglobinuria to reduce hemolysis.※発作性夜間血色素尿症（PNH）の治療薬

NDA Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New formulation
4 -   New combination
5 -   New manufacturer
7 -   Drug already marketed, but without an approved NDA

Review Classification:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
O -  OrphanDesignation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

●CDER Priority NDA and BLA Approvals in 2006

[-2006.12.28迄;最終更新2007.4.10]

●Priority New Drug Application (NDA) Approvals: L

NDA Number	ProprietaryName	Established Name	Applicant	Chemical Type	Review Classif ication	Approval Date	Indication
N021938	Sutent	sunitinib malate	Pfizer	1	P	26-Jan-06	N021938, Sutent is indicated for the treatment of gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate. Concurrently, N021668 Stutent, was also approved and and is indicated for the treatment of advanced renal cell carcinoma.
N021980	Fluorescite	fluorescein	Alcon Research	5	P	28-Mar-06	Provides for the use in diagnostic fluoresceine angiography or angioscopy of the retina and iris vasculature.
N021897	Vivitrol	naltrexone	Alkermes	3	P	13-Apr-06	Provides for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol.
N021903	NeoProfen	ibuprofen lysine	Farmacon-IL, LLC	2	P, O	13-Apr-06	Provides for  the treatment for closure of a clinically significant patent ductus arteriosus in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management (e.g.., fluid restriction, diuretics, respiratory support, etc.) is ineffective.
N021928	Chantix	varenicline	Pfizer	1	P	10-May-06	Provides for use as an aid for smoking cessation.
N021976	Prezista	darunavir	Tibotec	1	P	23-Jun-06	When coadministered with 100 mg of ritonavir, provides for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.
N021986	Sprycel	dasatinib	Bristol-Myers Squibb	1	P, O	28-Jun-06	Provides for the treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib.
N021937	Atripla	efavirenz; emtricitabine; tenofovir disoproxil fumarate	Gilead Sciences	4	P	12-Jul-06	Provides for the treatment of HIV-1 either alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
N022003	Noxafil	posaconazole	Schering	1	P	15-Sep-06	Provides for the treatment of prophylaxis of invasive Aspergillus and Candida infections in patients, 13 years of age and older, who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with Graft versus Host Disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy.
N021983	Duodote	atropine; pralidoxime chloride	Meridian Medical Technologies	5	P	28-Sep-06	Provides for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.
N021991	Zolinza	vorinostat	Merck	1	P,O	06-Oct-06	Provides for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
N022041	Cyanokit	hydroxocobalamin	EMD Pharms	3	P,O	15-Dec-06	Provides for the treatment of known or suspected cyanide poisoning.

 

●New Drug Application (NDA) Tentative Approvals under the President's Emergency Plan for AIDS Relief (PEPFAR):

NDA Number	ProprietaryName	Proper Name	Applicant	Chemical Type	Review Classification	Approval Date	Indication
N021943	efavirenz; lamivudine; zidovudine	efavirenz; lamivudine;  zidovudine	Aurobindo	4	P	06-Mar-06	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021939	lamivudine; zidovudine; nevirapine	lamivudine; zidovudine; nevirapine	Aurobindo	4	P	30-Jun-06	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021944	lamivudine; zidovudine; abacavir sulfate	lamivudine; zidovudine;  abacavir sulfate	Aurobindo	4	P	30-Jun-06	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N022018	lamivudine; zidovudine;	lamivudine; zidovudine;	Pharmacare	4	P	28-Aug-06	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.
N021969	lamivudine; stavudine; nevirapine	lamivudine; stavudine; nevirapine	Cipla Limited	4	P	17-Nov-06	Provides in combination with other antiretroviral agents for the treatment of HIV-1 infection.

N021943 is lamivudine 150mg/zidovudine 300mg Fixed-Dose Tablets co-packaged with efavirenz 600mg Tablets.
N021939 is lamivudine 150mg/zidovudine 300mg/nevirapine 200mg.

N021944 is lamivudine 150mg/zidovudine 300mg co-packaged with abacavir 300mg Tablets.

N022018 is lamivudine 150mg/zidovudine 300mg.

N021969 lamivudine 150mg/stavudine 30mg/nevirapine 200mg and  lamivudine 150mg/stavudine 40mg/nevirapine 200mg Tablets

 

●Priority Biologic License Application (BLA) Approvals:

BLA Number	ProprietaryName	Proper Name	Applicant	Review Classification	Approval Date	Indication
125141	Myozyme	alglucosidase alfa	Genzyme	P, O	28-Apr-06	Provides for the treatment of Pompe disease (GAA deficiency).
125156	Lucentis	ranibizumab	Genentech	P	30-Jun-06	Provides for the treatment of patients with neovascular (wet) age-related macular degenaration.
125151	Elaprase	idursulfase	Shire Human Genetic Therapies	P, O	24-Jul-06	Provides for the treatment of patients with Hunter syndrome (Mucopolysaccharidosis II, MPS II).
125147	Vectibix	panitumumab	Amgen	P	27-Sep-06	Provides for the treatment of EGFR-expressing metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan containing chemotherapy regimens.

 

NDA Chemical Type:
1 -   New molecular entity
2 -   New ester, new salt, or other noncovalent derivative
3 -   New formulation
4 -   New combination
5 -   New manufacturer
7 -   Drug already marketed, but without an approved NDA

Review Classification:  
P -   Priority Review - Significant improvement compared to marketed products, in the treatment, diagnosis, or prevention of a disease.
O -  OrphanDesignation - Pursuant to Section 526 of the Orphan Drug Act (Public Law 97-414 as amended).

 

●CDER Priority NDA and BLA Approvals in 2005

Updated through December 31, 2005

●Priority New Drug Application (NDA) Approvals:

ML
NDA Number
ProprietaryName
Established Name
Applicant
Chemical
Type
Review 
Classif
ication
Approval Date
Indication
　
N021841
Lamivudine;Zidovudine; Nevirapine
Lamivudine;Zidovudine; Nevirapine
Pharmacare
4
P
24-Jan-05*
Lamivudine; Zidovudine; Nevirapine is indicated for treatment of HIV-1 infection.
　
N020645
Ammonul
Sodium Benzoate;Sodium Phenylacetate
UcyclydPharma
5
P, O
17-Feb-05
Ammonul is indicated as an adjunctivetherapy in the treatment of acute hyperammonemia andassociated encephalopathy in patients with deficiencies inenzymes of the urea cycle.
1211
N021506
Mycamine
MicafunginSodium
Fujisawa
1
P
16-Mar-05
Mycamine is indicated for prophylaxis ofCandida infections in patients undergoing hematopoietic stemcell transplantation.
1210
N021797
Baraclude
Entecavir
Bristol MyersSquibb
1
P
29-Mar-05
Baraclude is indicated for the treatmentof chronic hepatitis B virus infection in adults with evidenceof active viral replication and either evidence of persistentelevations in serum aminotransferases (ALT or AST) orhistologically active disease.
1210
N021797
Baraclude
Entecavir
Bristol MyersSquibb
3
P
29-Mar-05
Baraclude is indicated for the treatmentof chronic hepatitis B virus infection in adults with evidenceof active viral replication and either evidence of persistentelevations in serum aminotransferases (ALT or AST) orhistologically active disease.
　
N021737
Retisert
FluocinoloneAcetonide
Bausch &Lomb
3
P, O
08-Apr-05
Retisert is indicated for the treatmentof chronic non-infectious uveitis affecting the posteriorsegment of the eye.
　
N021845
Revatio
SildenafilCitrate
Pfizer
5
P
03-Jun-05
Revatio isindicated for the treatment of pulmonary arterial hypertension(WHO Group I) to improve exercise ability. The efficacy ofRevatio has not been evaluated in patients currently onbosentan therapy.
　
N021821
Tygacil
Tigecycline
WyethPharms
1
P
15-Jun-05
Tygacil isindicated for the treatment of Complicated Skin and SkinStructure Infections (cSSSI) and Complicated Intra-abdominalInfections (cIAI).
　
N021814
Aptivus
Tipranavir
BoehringerIngelheim
1
P
22-Jun-05
Aptivusco-administered with 200 mg of ritonavir, is indicated forcombination antiretroviral treatment of HIV-1 infected adultpatients with evidence of viral replication, who are highlytreatment-experienced or have HIV-1 strains resistant tomultiple protease inhibitors.
　
N021862
Nevanac
nepafenac
Alcon
1
P
19-Aug-05
Nevanac is indicated for the treatment ofpain and inflammation associated with cataractsurgery.
　
N021839
Increlex
mecasermin (rDNA origin)
Tercica
1
P, O
30-Aug-05
Increlex is indicated for the long-termtreatment of growth failure in children with severe primaryIGF-1 deficiency (Primary IGFD) or with growth hormone (GH)gene deletion who have developed neutralizing antibodies togrowth hormone.
　
N021896
Emtriva
Emtricitabine
Gilead
3
P
28-Sep-05
Emtriva is indicated in combination with other antiretroviral agents, for the treatment of HIV-1 infection in patients over three months of age.
　
N021716
Hydase
Hyaluronidase
PrimaPharm
1
P
25-Oct-05
Hydase is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
　
N021877
Arranon
Nelarabine
GlaxoSmithKline
1
P, O
28-Oct-05
Arranon is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
　
N021906
Kaletra
Lopinavir; Ritonavir
Abbott Labs
3
P
28-Oct-05
Kaletra in combination with other antiretroviral agents, is indicated for the treatment of HIV-infection.
　
N021882
Exjade
Deferasirox
Novartis
1
P, O
02-Nov-05
Exjade is indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
　
N021859
Hylenex
Recombinant Hyaluronidase
Human Halozyme
1
P
02-Dec-05
Hylenex recombinant is indicated as an adjuvant to increase the absorption and dispersion of other injected drugs; for hypodermoclysis; and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents.
　
N021884
Iplex
Mecasermin Rinfabate [rDNA Origin]
Insmed
1, 4
P, O
12-Dec-05
Iplex is indicated for the treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone.
　
N021923
Nexavar
Sorafenib Tosylate
Bayer
1
P, O
20-Dec-05
Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma.
　
N021880
Revlimid
Lenalidomide
Celgene
1
P, O
27-Dec-05
Revlimid is indicated for the treatment of patients with transfusion dependent anemia due to low or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5 q cytogenetic abnormality with or without additional cytogenetic abnormalities


●Priority Biologic License Application (BLA) Approvals:

ML
BLANumber
ProprietaryName
Proper Name
Applicant
Review Classification
Approval Date
Indication
　
BL125117
Naglazyme
Galsulfase
Biomarin Pharmaceutical Inc.
P, O
31-May-05
Treatment of patientswith Mucopolysaccharidosis VI (MPS VI)
　
BL125118
Orencia
Abatacept
Bristol-Myers Squibb
P
23-Dec-05
Abatacept is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease Modifying Anti-Rheumatoid Drugs (DMARDs), such as methotrexate or TNF antagonists.  Abatacept may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists.



●CDER Priority NDA and BLA Approvals in 2004

Updated through December 31, 2004
●Priority New Drug Application (NDA) Approvals:


ML
NDA Number
ProprietaryName
Established Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
　
N021539
Acetadote
Acetylcysteine
Cumberland Pharms
3
P, O
23-Jan-04

Acetadote is indicated to be administered intravenouslywithin 8 to 10 hours after ingestion of a potentiallyhepatotoxic quantity of acetaminophen, to prevent or lessenhepatic injury. 
　
N021462
Alimta
Pemetrexed Disodium
Eli Lilly
1
P, O
04-Feb-04
Alimta is indicated in the treatment of patients withmalignant pleural mesothelioma whose disease is eitherunresectable or who are otherwise not candidates for curativesurgery.
　
N021688
Sensipar
Cinacalcet Hydrochloride
Amgen
1
P
08-Mar-04
Sensipar is indicated for the treatment of secondaryhyperparathyroidism in patients with chronic kidney disease ondialysis, and the treatment of hypercalcemia in patients withparathyroidcarcinoma.     
　
N021256
Human Secretin
Human Secretin
Chirhoclin
1
P, O
09-Apr-04
Human Secretin is indicated for (1) Stimulation ofpancreatic secretions, including bicarbonate, to aid in thediagnosis of pancreatic exocrine dysfunction, (2) Stimulationof gastrin secretion to aid in the diagnosis of gastrinoma,and (3) Stimulation of pancreatic secretions to facilitate theidentification of the ampulla of Vater and accessory papilladuring endoscopic retrograde cholangiopancreatography(ERCP).
1200
N021264
Apokyn
Apomorphine Hydrochloride
Bertek
1
P
20-Apr-04
Apokyn is indicated for the acute, intermittenttreatment of hypomobility, "off" episodes ("end-of-dosewearing off" and unpredictable "on/off" episodes) associatedwith advanced Parkinson's disease.
　
N021640
Vitrase
Ovine Hyaluronidase
Ista Pharms
1
P
05-May-04
Vitrase is indicated as an adjuvant to increase theabsorption and dispersion of other injected drugs; forhypodermoclysis; and as an adjunct in subcutaneous urographyfor improving resorption of radiopaque agents.
1201
N050794
Vidaza
Azacitidine
Pharmion
1
P, O
19-May-04
Vidaza is indicated for the treatment of patients withthe following myelodysplastic syndrome subtypes: refractoryanemia or refractory anemia with ringed sideroblasts (ifaccompanied by neutropenia or thrombocytopenia and requiringtransfusions), refractory anemia with excess blasts,refractory anemia with excess blasts in transformation, andchronic myelomonocytic leukemia.
　
N021497
Alinia
Nitazoxanide
Romark
3
P
21-Jul-04
Alinia is indicated for the treatment of diarrheacaused by Giardia Lamblia in patients 12 years andolder.
1199
N021431
Campral
Acamprosate Calcium
Lipha
1
P
29-Jul-04
Campral is indicated for the maintenance of abstinencefrom alcohol in patients with alcohol dependence who areabstinent at treatment initiation.
1203
配
N021752
Truvada
Emtricitabine; Tenofovir DisoproxilFumarate
Gilead Sciences
4
P
02-Aug-04
Truvada is indicated in combination with otherantiretroviral agents (such as non-nucleoside reversetranscriptase inhibitors or protease inhibitors) for thetreatment of HIV-1 infection in adults.
　
N021749
Pentetate Calcium Trisodium
Pentetate Calcium Trisodium
Pharma Hameln GmbH
1
P
11-Aug-04
Pentetate Calcium Trisodium is indicated for thetreatment of internal contamination with plutonium, americiumor curium to increase the rates of elimination.
　
N021751
Pentetate Zinc Trisodium
Pentetate Zinc Trisodium
Pharma Hameln GmbH 
1
P
11-Aug-04
Pentetate Zinc Trisodium is indicated for the treatmentof internal contamination with plutonium, americium or curiumto increase the rates of elimination.
　
N021563
Clarinex
Desloratadine
Schering
3
P
01-Sep-04
Clarinex is indicated for the relief of the nasal andnon-nasal symptoms of perennial allergic rhinitis, and thesymptomatic relief of pruritus, reduction in the number ofhives, and size of hives, in patients with chronic idiopathicurticaria in children 6 months to 2 years of age.
　
N021683
Manoplex
Insoluble PrussianBlue
DegussaLimited
5
P
14-Oct-04*
Manoplex is indicated for the treatmentof patients with known or suspected internal contaminationwith radioactive cesium and/or radioactive or non-radioactivethallium to increase their rates of elimination.
　
N021665
Amphadase
(hyaluronidase)
Amphadase
(hyaluronidase)
AmphastarPharms
1
P
26-Oct-04
Amphadase is indicated as an adjuvant toincrease the absorption and dispersion of other injecteddrugs; for hypodermoclysis; and as an adjunct in subcutaneousurography for improving resorption of radiopaqueagents.
1205
N021743
Tarceva
(erlotinib)
Tarceva
(erlotinib)
OSIPharms
1
P
18-Nov-04
Tarceva is indicated for the treatment oflocally advanced or metastatic Non Small-Cell Lung Cancer(NSCLC) after failure of at least one prior chemotherapyregimen.
　
N021786
Kelacal
Pentetate CalciumTrisodium
CIS-US
5
P
01-Dec-04*
Kelacal is indicated for the treatment ofinternal contamination with plutonium, americium, orcurium.
　
N021787
Kelazin
Pentetate ZincTrisodium
CIS-US
5
P
01-Dec-04*
Kelazin is indicated for the treatment ofinternal contamination with plutonium, americium, orcurium.
　
N021670
VisionBlue
TrypanBlue
DORC
1
P
16-Dec-04
Vision Blue isindicated as an aid in ophthalmic surgery by staining theanterior capsule of the lens.
1212
N021756
Macugen
Pegaptanibsodium
Eyetech
1
P
17-Dec-04
Macugen isindicated for the treatment of neovascular (wet) age-relatedmacular degeneration.
　
N021785
Invirase
SaquinavirMesylate
Hoffman-LaRoche
3
P
17-Dec-04
Invirase isindicated in combination with other antiretroviral agents forthe treatment of HIV-1 infection in adults.
　
N021060
Prialt
Ziconotide
ElanPharms
1
P
28-Dec-04
Prialt isindicated for the management of severe chronic pain inpatients for whom intrathecal (IT) therapy is warranted andwho are intolerant of or refractory to other treatment, suchas systemic analgesics, adjunctive therapies, or ITmorphine.
　
N021673
Clolar
Clofarabine
Genzyme
1
P, O
28-Dec-04
Clolar isindicated for the treatment of pediatric patients 1 to 21years old with relapsed or refractory acute lymphoblasticleukemia after at least two prior regimens.
　
N021779
Ventavis
Iloprost
CoTherix
1
P, O
29-Dec-04
Ventavis isindicated for the treatment of pulmonary arterialhypertension.
　
N021446
Lyrica
Pregabalin
Pfizer
1
P
30-Dec-04
Lyrica isindicated for the management of neuropathic pain associatedwith diabetic peripheralneuropathy.

●Priority Biologic License Application (BLA) Approvals:


ML
BLANumber
ProprietaryName
Proper Name
Applicant
Review Classification
Approval Date
Indication
　
BL125084
Erbitux
Cetuximab
ImClone Systems
P
12-Feb-04
Erbitux is indicatedfor the treatment of EGFR-expressing, metastatic colorectalcarcinoma in patients who are refractory to irinotecan-basedchemotherapy (in combination with irinotecan); Treatment ofEGFR-expressing, metastatic colorectal carcinoma in patientswho are intolerant to irinotecan-based chemotherapy(administered as a single agent).
　
BL125085
Avastin
Bevacizumab
Genentech
P
26-Feb-04
Avastin is indicatedfor the first-line treatment of patients with metastaticcarcinoma of the colon and rectum (in combination withintravenous 5-fluorouracil-basedchemotherapy).
1202
1204
BL125104
Tysabri
Natalizumab
Biogen Idec
P
23-Nov-04
Tysabri is indicated in the treatment ofpatients with relapsing forms of multiple sclerosis (MS) toreduce the frequency of clinical exacerbations.
1207
BL125103
Kepivance
Palifermin
Amgen
P
15-Dec-04
Kepivance is indicated to decrease theincidence and duration of severe oral mucositis in patientswith hematologic malignancies receiving myelotoxic therapyrequiring hematopoietic stem cell support.



●CDER Priority NDA and BLA Approvals in 2003

Updated through December 31, 2003


ML
NDA Number
ProprietaryName
Established Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
　
N020414
Pyridostigmine Bromide
Pyridostigmine Bromide
U.S. Army
3
P
05-Feb-03
Pyridostigmine bromide is indicated for prophylaxisagainst the lethal effects of Soman nerve agentpoisoning.
1159
N021481
Fuzeon 
Enfuvirtide
Hoffman-La Roche
1
P
13-Mar-03
Fuzeon is indicated for the use in combination withother antiretroviral agents, for the treatment of HIV-1infection in treatment experienced patients with evidence ofHIV-1 replication despite ongoing antiretroviraltherapy.
1160
N021106
Somavert 
Pegvisomant
Pharmacia & Upjohn
1
P, O
25-Mar-03
Somavert is indicated for the treatment of acromegalyin patients who have an inadequate response to surgery and/orradiation therapy and/or other medical therapies, or for whomthese therapies are not appropriate.
1162
N021549
Emend
Aprepitant
Merck
1
P
26-Mar-03
Emend is indicated to be used in combination with otherantiemetic agents, for the prevention of acute and delayednausea and vomiting associated with initial and repeat coursesof highly emetogenic cancer chemotherapy, including high-dosecisplatin.
1106
N021588
Gleevec
Imatinib Mesylate
Novartis Pharms
3
P
18-Apr-03
Gleevec is indicated for the treatment of newlydiagnosed adult patients with Philadelphia chromosome positivechronic myeloid leukemia (CML) in chronic phase and in blastcrisis, accelerated phase, or in chronic phase after failureof interferon-alpha therapy. It is also indicated for thetreatment of patients with Kit (CD117) positive unresectableand/or metastatic malignant gastrointestinal stromal tumors(GIST).
1138
N021399
Iressa
Gefitinib
AstraZeneca
1
P
05-May-03
Iressa is indicated as monotherapy for the treatment ofpatients with locally advanced or metastatic non-small celllung cancer after failure of both platinum-based and docetaxelchemotherapies.
1161
N021602
Velcade
Bortezomib
Millennium Pharms
1
P, O
13-May-03
Velcade is indicated for the treatment of multiplemyeloma patients who have received at least two priortherapies and have demonstrated disease progression on thelast therapy.
1169
N021567
Reyataz
Atazanavir
Bristol-Myers Squibb
1
P
20-Jun-03
Reyataz is indicated in combination withother antiretroviral agents for the treatment of HIV-1infection in adults.
　
N021546
Rebetol
Ribavirin
Schering
3
P, O
29-Jul-03
Rebetol is indicated to be used as partof combination therapy with Intron A for the treatment ofchronic Hepatitis C among previously untreated pediatric atleast three years of age or older.
1175
N021572
Cubicin
Daptomycin
Cubist
1
P
12-Sep-03
Cubicin is indicated for the treatment ofcomplicated skin and skin structure infections caused bysusceptible strains of the following Gram-positivemicroorganisms: Staphylococcus aureus (includingmethicillin-resistant strains), Streptococcus pyogenes,Streptococcus agalactiae, Streptococcus dysgalactiae subsp.equisililis and Enterococcus faecalis (vancomycin-susceptiblestrains only).
　
N021626
Radiogardase
Prussian Blue
Heyl Chemisch-pharmazeutische Fabrik GmbH
1
P, O
02-Oct-03
Radiogardase is indicated for thetreatment of patients with known or suspected internalcontamination with radioactive cesium and/or radioactive ornon-radioactive thallium to increase their rates ofelimination.
　
N021320
Plenaxis
Abarelix
Praecis
1
P
25-Nov-03
Plenaxis is indicated for the palliativetreatment of men with advanced symptomatic prostate cancer, inwhom LHRH agonist therapy is not appropriate and who refusesurgical castration, and have one or more of the following:(1) risk of neurological compromise due to metastases, (2)ureteral or bladder outlet obstruction due to localencroachment or metastatic disease, or (3) severe bone painfrom skeletal metastases persisting on narcoticanalgesia.
　
N021388
Sterile Talc Powder
Sterile Talc Powder
Bryan
3
P, O
15-Dec-03
Sterile Talc Powder is indicated foradministering intrapleurally via chest-tube as a sclerosingagent to decrease the recurrence of malignant pleuraleffusions in symptomatic patients.
　
N021520
Symbyax
Olanzapine; Fluoxetine Hydrochloride
Eli-Lilly
4
P
24-Dec-03
Symbyax is indicated for the use as acombination product in the treatment of depressive episodesassociated with bipolar disorder.


●CDER Priority NDA and BLA Approvals in 2002

Updated through December 31, 2002
 


ML
NDA Number
ProprietaryName
Established Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
　
N021175
Atnaa
Atropine; Pralidoxime Chloride
U.S. Army
3
P
17-Jan-02
Atnaa provides for the use in an autoinjector for thetreatment of poisoning by susceptible organophosphorous nerveagents having anticholinesterase activity.
　
N021232
Orfadin
Nitisinone
Swedish Orphan
1
P, O
18-Jan-02
Orfadin provides for the use for adjunctive therapy todietary restriction of tyrosine and phenylalanine in thetreatment of hereditary tyrosinemia type 1.
　
N021272
Remodulin
Treprostinil Sodium
United Therapeutics
1
P, O
21-May-02
Remodulin is indicated for the treatment of pulmonaryarterial hypertension (PAH).
　
N021196
Xyrem
Sodium Oxybate
Orphan Medical
1
P, O
17-Jul-02
Xyrem is indicated for the treatment of cataplexyassociated with narcolepsy.
　
N021200
Zelnorm
Tegaserod Maleate
Novartis Pharms
1
P
24-Jul-02
Zelnorm is indicated for the short-term treatment ofwomen with irritable bowel syndrome (IBS) whose primary bowelsymptom is constipation.
　
N021492
Eloxatin
Oxaliplatin
Sanofi-Synthelabo
1
P
09-Aug-02
Eloxatin is indicated in combination with infusional5-FU/LV for the treatment of patients with metastaticcarcinoma of the colon or rectum whose disease has recurred orprogressed during or within 6 months of completion of firstline therapy with the combination of bolus 5-FU/LV andirinotecan.
　
N021449
Hepsera
Adefovir Dipivoxil
Gilead Sciences
1
P
20-Sep-02
Hepsera is indicated for the treatment of chronichepatitis B in adults with evidence of active viralreplication and either evidence of persistent elevations inserum alanine aminotransferase (ALT)/aspartateaminotransferase (AST) or histologically activedisease.
1150
N020733
Suboxone
Buprenorphine Hydrochloride; Naloxone HydrochlorideDihydrate
Reckitt Benckiser
4
P, O
08-Oct-02
Suboxone is indicated for the treatment of opioiddependence in patients 16 years of age and older.
1154
N021498
Alinia
Nitazoxanide
Romark Labs
1
P
22-Nov-02
Alinia is indicated for the treatment of diarrheacaused by Cryptosporidium parvum and Giardia lamblia.
1151
N021511
Copegus
Ribavirin
Hoffmann-La Roche
3
P
03-Dec-02
Copegus is indicated for the treatment of chronichepatitis C virus infection for use in combination with theapproved biologic product Pegasys (peginterferonalfa-2a).
1157
N021023
Restasis 
Cyclosporine
Allergan
3
P
23-Dec-02
Restasis is indicated to increase tear production inpatients whose tear production is presumed to be suppresseddue to ocular inflammation associated withkeratoconjunctivitis sicca. Increased tear production was notseen in patients currently taking topical anti-inflammatorydrugs or using punctal plugs.


●CDER Priority NDA and BLA Approvals in 2001

Updated through December 31, 2001
 


ML
NDA Number
ProprietaryName
Established Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
　
N021252
Canasa
Mesalamine 
Axcan Scandipharm
5
P
05-Jan-01
Canasa is indicated for the treatment of activeulcerative proctitis.
　
N021227
Cancidas
Caspofungin Acetate
Merck Research Labs
1
P
26-Jan-01
Cancidas is indicated for the treatment of invasiveaspergillosis in patients who are refractory to or intolerantof other therapies.
　
N021257
Travatan
Travoprost
Alcon Universal
1
P
16-Mar-01
Travatan is indicated for the reduction of intraocularpressure in patients with open-angle glaucoma or ocularhypertension who are intolerant of other intraocular pressurelowering medications or insufficiently responsive (failed toachieve target IOP determined after multiple measurements overtime) to another intraocular pressure lowering medication.
　
N021275
Lumigan
Bimatoprost
Allergan
1
P
16-Mar-01
Lumigan is indicated for the reduction of elevatedintraocular pressure in patients with open-angle glaucoma orocular hypertension who are intolerant of other intraocularpressure lowering medications or insufficiently responsive(failed to achieve target IOP determined after multiplemeasurements over time) to another intraocular pressurelowering medication. 
　
N021304
Valcyte 
Valganciclovir Hydrochloride
Syntex (USA)
2
P
29-Mar-01
Valcyte is indicated for the treatment ofcytomegalovirus(CMV) retinitis in patients with acquiredimmunodeficiency syndrome (AIDS).
　
N021335
Gleevec
Imatinib Mesylate
Novartis Pharms
1
P, O
10-May-01
Gleevec is indicated for the treatment of patients withchronic myeloid leukemia (CML) in blast crisis, acceleratedphase, or in chronic phase after failure of interferon-alphatherapy.
　
N021223
Zometa
Zoledronic Acid
Novartis Pharms
1
P
20-Aug-01
Zometa is indicated for the treatment of hypercalcemiaof malignancy.
　
N021324
Entocort EC
Budesonide
AstraZeneca
3
P
02-Oct-01
Entocort EC is indicated for the treatment of mild tomoderate active Crohn's Disease involving the ileum and/orascending colon.
　
N021356
Viread
Tenofovir Disoproxil Fumarate
Gilead Sciences
1
P
26-Oct-01
Viread is indicated to be used in combination withother antiretroviral agents for the treatment of HIV-1infection in adults.
　
N021345
Arixtra
Fondararinux Sodium
Fonda BV
1
P
07-Dec-01
Arixtra is indicated for the following: the prophylaxisof deep vein thrombosis, which may lead to pulmonary embolism:1) in patients undergoing hip fracture surgery; 2) in patientsundergoing hip replacement surgery; 3) in patients undergoingknee replacement surgery.


●CDER Priority NDA and BLA Approvals in 2000

Updated through December 31, 2000


ML
NDA Number
ProprietaryName
Established Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
　
N021107
Lotronex
Alosetron Hydrochloride
Glaxo Wellcome
1
P
09-Feb-00
Lotronex isindicated for the treatment of irritable bowel syndrome (IBS)in female patients whose predominant bowel symptom isdiarrhea.
　
N021084
Skin Exposure Reduction Paste Against Chemical WarfareAgents
Perfluoropolymethylisopropyl  Ether;Polytetrafluoroethylene
U.S.Army
1, 4
P
17-Feb-00
Provides forthe use of SERPACWA only in conjunction with Mission OrientedProtective Posture (MOPP) gear to reduce or delay theabsorption of chemical warfare agents through the skin whenSERPACWA is applied prior to exposure.
　
N021114
Betaxon
Levobetaxolol Hydrochloride
Alcon
2
P
23-Feb-00
Betraxon isindicated for lowering intraocular pressure in patients withchronic open-angle glaucoma or ocularhypertension.
　
N021119
Visudyne
Verteporfin
QLTPhoto
1
P
12-Apr-00
Visudyneprovides for the treatment of age-related macular degenerationin patients with predominantly classic subfoveal choroidalneovascularization.
　
N021130
Zyvox
Linezolid
Pharmacia & Upjohn
1
P
18-Apr-00 
Zyvox is indicatedfor the treatment of adult patients with vancomycin-resistantEnterococcus faecium infections, nosocomial pneumonia,complicated and uncomplicated skin and skin structureinfections, and community-acquiredpneumonia.
　
N021131
Zyvox
Linezolid
Pharmacia & Upjohn
3
P
18-Apr-00 
Zyvox is indicatedfor the treatment of adult patients with vancomycin-resistantEnterococcus faecium infections, nosocomial pneumonia,complicated and uncomplicated skin and skin structureinfections, and community-acquiredpneumonia.
　
N021132
Zyvox
Linezolid
Pharmacia & Upjohn
3
P
18-Apr-00 
Zyvox is indicatedfor the treatment of adult patients with vancomycin-resistantEnterococcus faecium infections, nosocomial pneumonia,complicated and uncomplicated skin and skin structureinfections, and community-acquiredpneumonia.
　
N021174
Mylotarg
Gemtuzumab Ozogamicin
Wyeth-Ayerst
1
P, O
17-May-00 
Mylotarg is indicated for the treatment pf patientswith CD33 positive acute myeloid leukemia in first relapse whoare 60 years of age or older and who are not consideredcandidates for cytotoxic chemotherapy.
　
N021056
Targretin
Bexarotene
LigandPharm
3
P, O
28-Jun-00 
Targretin gel 1% isindicated for the treatment of cutaneous lesions in patientswith CTCL (Stage 1A and 1B) who have refractory or persistentdisease after other therapies or who have not tolerated othertherapies.
　
N021078
Malarone; Malarone Pediatric
Atovaquone; Proguanil Hydrochloride
GlaxoWellcome
4
P
14-Jul-00 
Malarone is indicatedfor the treatment and prevention of plasmodium falciparummalaria.
　
N021214
Rescula
Unoprostone Isopropyl
Ciba Vision
1
P
03-Aug-00
Rescula is indicatedfor the lowering of intraocular pressure in patients withopen-angel glaucoma or ocular hypertension who are intolerantof other intraocular pressure lowering medications orinsufficiently responsive (failed to achieve target IOPdetermined after multiple measurements over time) to anotherintraocular pressure lowering medication.
　
N020929
Pulmicort Respules
Budesonide
AstraZeneca
3
p
08-Aug-00
Pulmicort Respules isindicated for the maintenance treatment of asthma and asprophylactic therapy in children 12 months to 8 years ofage.
　
N021199
Quixin
Levofloxacin
Santen
3
P
18-Aug-00
Quixin is indicatedfor the treatment of bacterialconjunctivitis.
　
N021226
Kaletra
Lopinavir;Ritonavir
Abbott Labs
1, 4
P
15-Sep-00
Keletra is indicatedin combination with other antiretroviral agents for thetreatment of HIV-1 infections in adults and pediatric patientsage six months and older.
　
N021251
Kaletra
Lopinavir; Ritonavir
Abbott Labs
3, 4
P
15-Sep-00
Keletra is indicatedin combination with other antiretroviral agents for thetreatment of HIV-1 infections in adults and pediatric patientsage six months and older.
　
N021248
Trisenox
 
Arsenic Trioxide
 
Cell Therapeutics
1
P, O
25-Sep-00
Trisenox is indicatedfor induction of remission and consolidation in patients withacute promyelocytic leukemia (APL) who are refractory to, orhave relapsed from, retinoid and anthracycline chemotherapy,and whose APL is characterized by the presence of the t(15;17)translocation or PML/RAR-alpha geneexpression.
　
N020687
Mifeprex
 
Mifepristone)
 
Population Council
1
P
28-Sep-00
Mifeprex is indicatedfor the medical termination of intrauterine pregnancy through49 days� pregnancy.
　
N021183
Videx EC
 
Didanosine
 
Bristol-Myers Squibb
3
P
31-Oct-00
Videx EC, incombination with other antiretroviral agents, is indicated forthe treatment of HIV-1 infection in adults whose managementrequires once-daily administration of didanosine or analternative didanosine formulation.
　
N021205
Trizivir
Abacavir Sulfate; Lamivudine;Zidovudine
GlaxoWellcome
3
P
14-Nov-00
Trizivir provides for the useeither alone or in combination with other antiretroviralagents for the treatment of HIV-1infection.
　
N021246
Tamiflu
Oseltamivir Phosphate
Hoffmann-La Roche
3
P
14-Dec-00 
Tamiflu is indicated for thetreatment of uncomplicated acute illness due to influenza inpatients older than one year of age who have been symptomaticfor no longer than 2 days.


●CDER Priority NDA and BLA Approvals in 1999

Updated through December 31, 1999
 


ML
NDA Number
ProprietaryName
Established Name
Applicant
Chemical Type
Review Classification
Approval Date
Indication
　
N020886
Panretin
Alitretinoin
LigandPharm
1
P, O
02-Feb-99
Panretin isindicated for the treatment of cutaneous lesions in patientswith AIDS-related Kaposi's sarcoma.
　
N020954
Busulfex
Busulfan
OrphanMedical
3
P, O
04-Feb-99
Busulfex is used in combination with cyclophosphamide as a conditioning regimen prior toallogeneic hematopoietic progenitor cell transplantation forchronic myelogenous leukemia
　
N020955
Ferrlicit
Sodium Ferric Gluconate Complex
R&DLab
1
P
18-Feb-99
Ferrlicit isindicated for the treatment of iron deficiency anemia inpatients undergoing chronic hemodialysis who are receivingsupplemental erythropoietin therapy.
　
N021041
DepoCyt
Cytarabine Liposome
Depotech
3
P, O
01-Apr-99
DepoCyt is indicated for the intrathecal treatment of lymphomatousmeningitis.
　
N021007
Agenerase
Amprenavir
GlaxoWellcome
1
P
15-Apr-99
Agenerase isa protease inhibitor that is indicated, in combination withother antiretroviral agents, for the treatment of HIV-1infection.
　
N021039
Agenerase
Amprenavir
GlaxoWellcome
3
P
15-Apr-99
Agenerase isa protease inhibitor that is indicated, in combination withother antiretroviral agents, for the treatment of HIV-1infection.
　
N020766
Xenical
Orlistat
Hoffmann-LaRoche
1
P
23-Apr-99
Xenical isindicated for obesity management including weight loss andweight maintenance when used in conjunction with areduced-calorie diet.  Xenical is also indicated toreduce the risk for weight re-gain after priorloss.
　
N021042
Vioxx
Rofecoxib
Merck
1
P
20-May-99
Vioxx isindicated for the relief of the signs and symptoms ofosteoarthritis, for the management of acute pain and for thetreatment of primary dysmenorrhea.
　
N021052
Vioxx
Rofecoxib
Merck
3
P
20-May-99
Vioxx isindicated for the relief of the signs and symptoms ofosteoarthritis, for the management of acute pain and for thetreatment of primary dysmenorrhea.
　
N021071
Avandia
Rosiglitazone Maleate
SmithKlineBeecham
1
P
25-May-99
Avandia isindicated for the treatment of type 2 diabetes mellitus asmonotherapy or in combination withmetformin.
　
N021066
Zaditor
Ketotifen Fumarate
CibaVision
1
P
02-Jul-99
Zaditor isindicated for the prevention of itching of the eye due toallergic conjunctivitis.
　
N021073
Actos
Pioglitazone Hydrochloride
TakedaAmerica
1
P
15-Jul-99
Actos isindicated for the improvement of glycemic control in patientswith type 2 diabetes as monotherapy, or in combination with asulfonylurea, metformin or insulin when diet and the singleagent does not result in adequate glycemiccontrol.
　
N021036
Relenza
Zanamivir
GlaxoWellcome
1
P
26-Jul-99
Relenza isindicated for the treatment of uncomplicated acute illness dueto influenza virus in adults and adolescents twelve years andolder who have been symptomatic for no more than twodays.
　
N021045
Plan B
Levonorgestrel
WomensCapitol
3
P
28-Jul-99
Plan B isindicated as an emergency contraception.
　
N021057
Antagon
Ganirelix Acetate
Organon,Inc.
1
P
29-Jul-99
Antagon isindicated for the inhibition of premature LH surges in womenundergoing controlled ovarianhyperstimulation.
　
N021012
Neotect
Technetium Tc-99m Depreotide Kit
Diatide
1
P
03-Aug-99
TechnetiumTc-99m Depreotide is indicated for patients presenting withpulmonary lesions on computed tomography and/or chest x-raywho have known malignancy or who are highly suspect formalignancy.
　
N021029
Temodar
Temozolomide
Schering
1
P, O
11-Aug-99
Temodar isindicated for the treatment of adult patients with refractoryanaplastic astrocytoma, i.e., patients at first relapse whohave experienced disease progression on a drug regimencontaining a nitrosourea and procarbazine.
　
N021083
Rapamune
Sirolimus
Wyeth-Ayerst
1
P
15-Sep-99
Rapamune isindicated for prophylaxis of organ rejection in patientsreceiving renal transplants.
　
N050778
Ellence
Epirubicin Hydrochloride
Pharmacia& Upjohn
1
P, O
15-Sep-99
Ellence isindicated as a component of adjuvant therapy in patients withevidence of axillary node tumor involvement followingresection of primary breast cancer.
　
N050747
Synercid  I.V
Quinupristin; Dalfopristin
RhonePoulenc Rorer
1
P
21-Sep-99
Synercid  isindicated for the treatment of patients with serious orlife-threatening infections associated withvancomycin-resistant Enterococcus faecium (VREF)bacteremia.
　
N020793
Cafcit
Caffeine Citrate
OreadPediatric Roxane Dev.
2
P, O
21-Sep-99
Cafcit isindicated for the short term treatment of apnea of prematurityin infants between 28 and 33 weeks gestationalage.
　
N021079
Alamast
Pemirolast Potassium
Santen
1
P
24-Sep-99
Alamast isindicated for the prevention of itching of the eye due toallergic conjunctivitis.
　
N021087
Tamiflu
Oseltamivir Phosphate
Hoffmann-LaRoche
1
P
27-Oct-99
Tamiflu isindicated as a treatment of influenza A andB.
　
N020884
Aggrenox
Aspirin; Dipyridamole
BoehringerIngelheim
4
P
22-Nov-99
Aggrenox isindicated to reduce the risk of stroke in patients who havehad transient ischemia of the brain or completed ischemicstroke due to thrombosis.
　
N021009
Alocril
NedocromilSodium
Allergan
3
P
08-Dec-99
Alocril isindicated for the treatment of itching associated withallergic conjunctivitis.
　
N021075
Nutropin Depot
 
Somatropin rDNA Origin
 
Genentech
3
P, O
22-Dec-99
NutropinDepot is indicated for the long-term treatment of growthfailure due to a lack of adequate endogenous GH secretion foronce or twice-a-month administration.
　
N020845
INOmax
Nitric Oxide
INOTherapeutics
1
P, O
23-Dec-99
INOmax inconjunction with ventilatory support and other appropriateagents, is indicated for the treatment of term and near-term(>34 weeks) neonates with hypoxic respiratory failureassociated with clinical or echocardiographic evidence ofpulmonary hypertension, where it improves oxygenation andreduces the need for extracorporeal membraneoxygenation.
　
N021055
Targretin
Bexarotene
LigandPharm
1
P, O
29-Dec-99
Targretin isindicated for the treatment of cutaneous manifestations ofcutaneous T-cell lymphoma in patients who are refractory to atleast one prior systemic therapy.

Chemical Types:
 1 - New molecular entity
 3 - New formulation
 4 - New combination
P
 - Priority Review -Significant improvement compared to marketed products,
  in the treatment, diagnosis, or prevention of a disease.
S
 - Standard Review - The drug appears to have therapeutic qualities
 similar to those of one or more already marketed drugs.
V
 - Designated Orphan Drug - The sponsor of the drug has officially
 requested and received orphan designation pursuant to Section 526 of the
 Orphan Drug Act (Public Law 97-414 as amended).

■Accelerated and Restricted Approvals Under Subpart H/E★品目リスト

ここは、次の４パートに分けて収録。
NDAs
BLAs
NDA Supplements
BLA Supplemente



●NDAs Approved under Subpart H

 - http://www.fda.gov/cder/rdmt/accappr.htm ; 整列＝承認日順
・ (Updated through 12/31/2005, Posted March 31, 2006)  本資料は四半期毎更新。
  ここで扱う医薬品の承認は、surrogate endpoint もしくは生存や不可逆状態以外の
  clinical endpoint (つまり"Surrogate[代替]")[21 CFR 314.510]での効果に基づく。
  [21 CFR 314.510]
  あるいは、安全性等の観点から制限付きの承認。("Restricted" ) [21 CFR 314.520]. 
　※Endopoint 治験ナビ用語集：エンドポイント

　AP Time =Approval time(承認期間)
　Approval Basis: S=Surrogate
　                R=Restricted 

●2004年以降

ML
NDA #
Trade
 Name
Generic
 Name
Receipt Date
Approval Date
AP Time
Appr
oval
Basis
Indication
　
21880
Revlimid
lenalidomide
4/7/2005
12/27/2005
8.7
R
Provides for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
　
21882
Exjade
deferasirox
5/2/2005
11/2/2005
6.0
S
Provides for the use of Exjade(R) (deferasirox) Tablets for Oral Suspension for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older.
　
21877
Arranon
nelarabine
4/29/2005
10/28/2005
6.0
S
Provides for the use of Arranon (nelarabine) Injection for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens.
　
21814
Aptivus
tipranavir
12/22/2004
6/22/2005
6.0
S
Provides for the use of Aptivus(R) (tipranavir) capsules, 250 mg, coadministered with 200 mg of ritonavir, for combination antiretroviral treatment of HIV-1 infected adult patients with evidence of viral replication, who are highly treatment-experienced or have HIV-1 strains resistant to multiple protease inhibitors.
　
21673
Clolar
clofarabine
30-Mar-04
28-Dec-04
8.9
S
Provides for the use of Clolar (clofarabine) intravenous infusion for the treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
　
21322
Luveris
lutropin alfa
1-May-01
8-Oct-04
41.3
S
Provides for the use of LuverisR 75IU (lutropin alfa for injection), concomitantly administered with Gonal-f R (follitropin alfa for injection) for stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH < 1.2 IU/L)
1203
配
21752
Truvada
emtricitabine; tenofovir
12-Mar-04
2-Aug-04
4.7
S
Provides for the use of Truvada(TM) (emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg)) Tablets in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults
1203
配
21752
Truvada
emtricitabine; tenofovir
12-Mar-04
2-Aug-04
4.7
S
Provides for the use of Truvada(TM) (emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg)) Tablets in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults
1203
配
21752
Truvada
emtricitabine; tenofovir
12-Mar-04
2-Aug-04
4.7
S
Provides for the use of Truvada(TM) (emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg)) Tablets in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults
1203
配
21752
Truvada
emtricitabine; tenofovir
12-Mar-04
2-Aug-04
4.7
S
Provides for the use of Truvada(TM) (emtricitabine (200 mg) and tenofovir disoproxil fumarate (300 mg)) Tablets in combination with other antiretroviral agents (such as nonnucleoside reverse transcriptase inhibitors or protease inhibitors) for the treatment of HIV-1 infection in adults
　
　
　
　
　
　
　
　
　



●2003年迄

ML
NDA #
Trade
 Name
Generic
 Name
Receipt Date
Approval Date
AP Time
Appr
oval
Basis
Indication
　
20199
Hivid
Zalcitabine
31-Oct-91
19-Jun-92
7.6
S
Combination therapy with zidovudine in advanced HIV infection
　
50698
Biaxin
Clarithromycin (Suspension)
02-Nov-92
23-Dec-93
13.7
S
Treatment of disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium intracellular
　
20412
Zerit
Stavudine
28-Dec-93
24-Jun-94
5.9
S
Treatment of adults with advanced HIV infection - alternative  therapy
　
20212
Zinecard
Dexrazoxane
05-Aug-94
26-May-95
9.7 a
S
To reduce the incidence and severity of cardiomyopathy associated with doxorubicin administration in certain breast cancer patients
※註：当初の受付日は1992.2.10だが、承認期間は、追加適応の基礎となる臨床データの受付日1994.8.4を基に計算した。
0977
20498
Casodex
Bicalutamide
14-Sep-94
04-Oct-95
12.7
S
Use in combination therapy with a Luteinizing-Hormone Releasing Hormone (LHRH) analogue for the treatment of advanced prostate cancer
　
20564
Epivir
Lamivudine
07-Jul-95
17-Nov-95
4.4
S
Treatment of HIV infection in selected patients
　
20596
Epivir
Lamivudine
07-Jul-95
17-Nov-95
4.4
S
Treatment of HIV infection in selected patients
　
50718
Doxil
Doxorubicin HCl
(Liposomal 
formulation)
02-Sep-94
17-Nov-95
14.3
S
Treatment of AIDS-related Kaposi's sarcoma in patients with disease that has progressed on prior combination chemotherapy or in patients who are intolerant to such therapy
　
20628
Invirase
Saquinavir Mesylate
31-Aug-95
06-Dec-95
3.2
S
Treatment of advanced HIV infection in selected patients in combination with nucleoside analogues
　
20659
Norvir
Ritonavir
21-Dec-95
01-Mar-96
2.3
S
In combination with nucleoside analogues or as monotherapy for the treatment of HIV infection
　
20680
Norvir
Ritonavir
21-Dec-95
01-Mar-96
2.3
S
In combination with nucleoside analogues or as monotherapy for the treatment of HIV infection
　
20685
Crixivan
Indinavir
 Sulfate
31-Jan-96
13-Mar-96
1.4
S
Treatment of HIV infection in adults
　
20449
Taxotere
Docetaxel
27-Jul-94
14-May-96
21.6
S
Treatment of patients with locally advanced or metastatic breast cancer who have progressed or relapsed during anthracycline based therapy
　
20571
Camptosar
Irinotecan HCl
28-Dec-95
14-Jun-96
5.6
S
Treatment of refractory colorectal cancer
　
20636
Viramune
Nevirapine
23-Feb-96
21-Jun-96
3.9
S
Combination with nucleoside analogues for the treatment of HIV-1 infected adults who have experienced clinical and/or immunologic deterioration
　
20604
Serostim
Somatropin
11-Sep-95
23-Aug-96
11.4
S
Treatment of AIDS wasting associated with catabolism loss or cachexia
　
19815
ProAmatine
Midodrine HCl
25-Sep-95
06-Sep-96
11.4 b
S
Treatment of symptomatic orthostatic hypotension
※註：当初受付日は1988.4.28だが、承認の基となる臨床データの受付日1995.9.25を承認期間の計算式で使用。
　
20778
Viracept
Nelfinavir
 Mesylate
26-Dec-96
14-Mar-97
2.6
S
Treatment of HIV infection when therapy is warranted
　
20779
Viracept
Nelfinavir
 Mesylate
26-Dec-96
14-Mar-97
2.6
S
Treatment of HIV infection when therapy is warranted
　
20705
Rescriptor
Delavirdine
 Mesylate
15-Jul-96
04-Apr-97
8.7
S
Treatment of HIV infection in combination with appropriate antiretroviral agents when therapy is warranted
1039
20896
Xeloda
Capecitabine
31-Oct-97
30-Apr-98
6
S
Treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated
　
19832
Sulfamylon
Mafenide
 Acetate
31-Mar-97
05-Jun-98
14.2 c
S
Indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds
※註：オリジナルの受付日は1988.2.19だが、新適応承認の基礎となる臨床データの受付日1997.3.31を承認期間計算に使用。
1047
21024
Priftin
Rifapentine
22-Dec-97
22-Jun-98
6
S
Priftin is indicated for the treatment of pulmonary tuberculosis (TB)
1038
20785
Thalomid
Thalidomide
20-Dec-96
16-Jul-98
18.8
R
Thalomid is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL) and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrences
　
20933
Viramune
Nevirapine
20-Apr-98
11-Sep-98
4.7
S
Provides for an oral suspension, which is indicated for use in combination therapy with other antiretroviral agents for the treatment of HIV-1 infection  
1041
20972
Sustiva
Efavirenz
11-Jun-98
17-Sep-98
3.2
S
Provides for the use of efavirenz in combination with other antiretroviral agents for the treatment of HIV-1 infection
　
20747
Actiq
Fentanyl Citrate
13-Nov-96
04-Nov-98
23.7
R
For the management of breakthrough cancer pain in patients with malignancies who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain
1041
20977
Ziagen
Abacavir
 Sulfate
24-Jun-98
17-Dec-98
5.8
S
Provides for the use of Ziagen (abacavir sulfate), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
1041
20978
Ziagen
Abacavir
 Sulfate
24-Jun-98
17-Dec-98
5.8
S
Provides for the use of Ziagen (abacavir sulfate), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
　
21041
DepoCyt
Cytarabine
 Liposomal
 Injection
05-Oct-98
01-Apr-99
5.9
S
Depocyt is indicated for the intrathecal treatment of lymphomatous meningitis
1068
21029
Temodar
Temozolomide
 (Capsules)
13-Aug-98
11-Aug-99
11.9
S
Treatment of adult patients with refractory anaplastic astrocytoma, i.e., patients at first relapse who have experienced disease progression on a drug regimen containing a nitrosourea and procarbazine
1057
21007
Agenerase
Amprenavir
16-Oct-98
15-Apr-99
6
S
Provides for the use of Agenerase (amprenavir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
1057
21039
Agenerase
Amprenavir
08-Dec-98
15-Apr-99
4.2
S
Provides for the use of Agenerase (amprenavir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection
1066
50747
Synercid
Quinupristin/
Dalfopristin I.V.
05-Sep-97
21-Sep-99
7.8d
S
Treatment of vancomycin resistant Enterococcus faecium
※註：工場査察でネガティヴな結果が出たため、改善作業が行われていた期間(1998.3.5-1999.7.26)は承認期間から除いた。
1083
21174
Mylotarg
Gemtuzumab
 Ozogamicin
29-Oct-99
17-May-00
6.6
S
Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy
1095
21226
Kaletra
Lopinavir
/Ritonavir
01-Jun-00
15-Sep-00
3.5
S
Kaletra in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients age six months and older
1095
21251
Kaletra
Lopinavir
/Ritonavir
01-Jun-00
15-Sep-00
3.5
S
Kaletra in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients age six months and older
1091
20687
Mifeprex
Mifepristone
18-Mar-96
28-Sep-00
18.0e 
R
For medical termination of intrauterine pregnancy through 49 days' pregnancy
※註：メーカーの変更があり、新メーカーが決まるまでの期間(1996.9.18-1999.8.19)は承認期間から除いた。
　
21205
Trizivir
Abacavir
 Sulfate
, Lamivudine, 
and Zidovudine
17-Dec-99
14-Nov-00
10.9
S
Provides for the use of Trizivir either alone or in combination with other antiretroviral agents for the treatment of HIV-1 infection
1106
21335
Gleevec
Imatinib
 Mesylate
27-Feb-01
10-May-01
2.4
S
Provides for the use of Gleevec (imatinib mesylate) 50 and 100 mg capsules for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy
　
21356
Viread
Tenofovir
 Disoproxil
 Fumarate
01-May-01
26-Oct-01
5.9
S
In combination with other antiretroviral agents for the treatment of HIV-1 infection in adults
1127
21290
Tracleer
Bosentan
17-Nov-00
20-Nov-01
12.1
R
Treatment of pulmonary arterial hypertension
1139
21272
Remodulin
Treprostinil
 Sodium
16-Oct-00
21-May-02
19.1
S
Provides for the use of Remodulin (treprostinil sodium)
  Injection 1.0, 2.5, 5.0, and 10.0 mg/ml for the treatment of pulmonary arterial hypertension(PAH)
1145
21196
Xyrem
Sodium Oxybate
2-Oct-00
17-Jul-02
21.5
R
Provides for the use of Xyrem Oral Solution for the treatment of cataplexy associated with narcolepsy
1148
21492
Eloxatin
Oxaliplatin
24-Jun-02
9-Aug-02
1.5
S
Provides for the use of Eloxatin (oxaliplatin) for Injection in combination with infusional  5-FU/LV for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed during or within 6 months of completion of first line therapy with the combination of bolus 5-FU/LV and irinotecan
1159
21481
Fuzeon
Enfuvirtide
19-Sep-02
13-Mar-03
5.9
S
Provides for the use of Fuzeon (enfuvirtide) for injection, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in treatment experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy
1106
21588
Gleevec
Imatinib Mesylate
16-Dec-02
18-Apr-03
4.0
S
Provides for the use of Gleevec (imatinib mesylate) 100 mg and 400 mg tablets for the treatment of patients with chronic myeloid leukemia (CML) in blast crisis, accelerated phase, or in chronic phase after failure of interferon-alpha therapy
1138
21399
Iressa
Gefitinib
5-Aug-02
5-May-03
9.0
S
Provides for the use of IRESSA (gefitinib tablets) as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies
1161
21602
Velcade
Bortezomib
21-Jan-03
13-May-03
3.7
S
Provides for the use of Velcade (bortezomib) for Injection for the treatment of multiple myeloma patients who have received at least two prior therapies and have demonstrated disease progression on the last therapy
　
21320
Plenaxis
abarelix
12-Dec-00
25-Nov-03
35.4
R
Provides for the use of Plenaxis (abarelix for injectable suspension, 100 mg) for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia
　
　
　
　
　
　
　
　
　








●NDA Supplements Approved under Subpart H

 - http://www.fda.gov/cder/rdmt/accappr1.htm; 整列＝承認日順
・ (Updated through 12/31/2005, Posted March 31, 2006)  本資料は四半期毎更新。

ML
NDA #
Supp #
Trade
  Name
Generic
   Name
Clock
  Date
Approval
  Date
AP Time
Approval
  Basis
Indication
●2004年以降
　
20726
SE1 012
Femara
letrozole
28-Jun-05
28-Dec-05
6.0
S
Provides for the use of Femara(R) (letrozole tablets) for the adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer.
　
18662
SLR
Accutane
isotretinoin
27-Jun-05
12-Aug-05
1.5
R
Because of the teratogenicity of isotretinoin, this supplement proposes the iPLEDGE program, an enhanced risk minimization action plan (RiskMAP) designed to minimize drug exposure during pregnancy.
　
21272
SE3 002
Remodulin
treprostinil sodium
30-Jan-04
24-Nov-04
9.8
S
Provides for adding the infusion of Remodulin (treprostinil sodium) 1, 2.5, 5 & 10 mg/mL Injection via an indwelling central venous catheter to the labeling
　
21721
SE1 003
Levaquin
levofloxacin
12-Nov-04
24-Nov-04
0.4
S
Provides for the use of LevaquinR oral solution for the treatment of inhalational anthrax (post-exposure)
　
20635
SE1 035
Levaquin
levofloxacin
26-May-04
24-Nov-04
6.0
S
Provides for the use of LevaquinR injection for the treatment of inhalational anthrax (post-exposure)
　
20634
SE1 035
Levaquin
levofloxacin
26-May-04
24-Nov-04
6.0
S
Provides for the use of LevaquinR tablets for the treatment of inhalational anthrax (post-exposure)
　
20726
SE1 011
Femara
letrozole
29-Apr-04
29-Oct-04
6.0
S
Provides for the use of Femara for the extended adjuvant treatment of early breast cancer in postmenopausal women who have received five years of adjuvant tamoxifen therapy.
　
21677
N
Alimta
pemetrexed
4-Nov-03
19-Aug-04
9.5
S
Provides for the use of AlimtaR (pemetrexed for injection) as a single-agent for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after prior chemotherapy.

●2003年迄
　
50697
N
Biaxin
Clarithromycin (Tablets)
2-Nov-92
23-Dec-93
13.7
S
Treatment of disseminated mycobacterial infections due to Mycobacterium avium and Mycobacterium intracellular
　
20221
SE1 002
Ethyol
Amifostine
9-Feb-96
15-Mar-96
1.2
S
Provides for modification of Ethyol indications, to include

 treatment of patients with non-small cell lung cancer

　
20636
SE1 009
Viramune
Nevirapine 
16-Mar-98
11-Sep-98
5.9
S
Provides for the inclusion of pediatric information into the labeling
　
50718
SE1 006
Doxil
Doxorubicin HCl (Liposomal formulation)
29-Dec-98
28-Jun-99
6.0
S
Treatment of metastatic carcinoma of the ovary in patients with disease that is refractory to both paclitaxel- and platinum-based chemotherapy regimens
1045
21156
N
Celebrex
Celecoxib
25-Jun-99
23-Dec-99
6.0
S
To reduce the number of adenomatous colorectal polyps in Familial Adenomatous Polyposis (FAP), as an adjunct to usual care
1116-17
19537
SE1 038
CIPRO
Ciprofloxacin HCl
1-Mar-00
30-Aug-00
6.0
S
Provides for the use of CIPRO for inhalational anthrax (post-exposure)
1116-17
19847
SE1 024
CIPRO
Ciprofloxacin HCl
2-Mar-00
30-Aug-00
6.0
S
Provides for the use of CIPRO for inhalational anthrax (post-exposure)
1116-17
19857
SE1 027
CIPRO
Ciprofloxacin HCl
2-Mar-00
30-Aug-00
6.0
S
Provides for the use of CIPRO for inhalational anthrax (post-exposure)
1116-17
19858
SE1 021
CIPRO
Ciprofloxacin HCl
2-Mar-00
30-Aug-00
6.0
S
Provides for the use of CIPRO for inhalational anthrax (post-exposure)
1116-17
20780
SE1 008
CIPRO
Ciprofloxacin HCl
2-Mar-00
30-Aug-00
6.0
S
Provides for the use of CIPRO for inhalational anthrax (post-exposure)
1106
21335
SE1 001
Gleevec
Imatinib Mesylate
16-Oct-01
1-Feb-02
3.6
S
Provides for the use of Gleevec (imatinib mesylate) for the treatment of patients with Kit (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumors (GIST)
1081
21107
SE8 005
Lotronex
Alosetron HCl
7-Dec-01
7-Jun-02
6.0
R
Provides for the use of Lotronex only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:  chronic IBS symptoms (generally lasting 6 months or longer), had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and failed to respond to conventional therapy
1152
20541
SE1 010
 Arimidex
Anastrozole 
5-Mar-02 
>5-Sep-02
6.0
S
Provides for the use of ARIMIDEX (anastrozole) Tablets for adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer
1106
21335
SE1 004
Gleevec
Imatinib Mesylate
28-Jun-02
20-Dec-02
5.8
S
Provides for the use of Gleevec(imatinib mesylate), 100 mg capsules for the  treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia(CML).  Follow-up is limited.
1106
21335
SE5 003
Gleevec
Imatinib Mesylate
28-Jun-02
20-May-03
10.7
S
Provides for the use of Gleevec (imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival
1106
21335
SE5 001
Gleevec
Imatinib Mesylate
24-Apr-03
20-May-03
0.9
S
Provides for the use of Gleevec (imatinib mesylate) Tablets for the treatment of pediatric patients with Ph+ chronic phase CML whose disease has recurred after stem cell transplant or who are resistant to interferon alpha therapy. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival
　
　
　
　
　
　
　
　
　
　
R - Restricted  - Approval with restrictions to assure safe use.as recorded in 21 CFR 314.520 (Subpart H).
Type 6 NDAs follow the same performance rules as efficacy supplements and are included with supplement approvals








●Biological Products Approved under Subpart E

 - http://www.fda.gov/cder/rdmt/SubpartEBLA.htm; 整列＝承認日順
・ (Updated through 12/31/2005, Posted March 31, 2006)  本資料は四半期毎更新。

ML
STN #
Trade
  Name
Generic
   Name
Receipt
  Date
Approval
  Date
AP Time
Approval
  Basis
Indication
1202
1204
BL125104
Tysabri
natalizumab
24-May-04
23-Nov-04
5.97
S
Treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations
　
125084
Erbitux
cetuximab
14-Aug-03
12-Feb-04
5.95
　
Treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan); Treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy (administered as a single agent)
　
103979
Fabrazyme
agalsidase beta
23-Jun-00
24-Apr-03
34.05
S
Use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types
　
125019
Zevalin
ibritumomab tiuxetan
1-Nov-00
19-Feb-02
15.58
S
Treatment of patients with relapsed or refractory low grade, follicular, or transformed B-cell non-Hodgkin's lymphoma
　
103948
Campath
alemtuzumab
23-Dec-99
7-May-01
16.5
S
Treatment of B-cell chronic lymphocytic leukemia (B-CLL) in patients who have been treated with alkylating agents and who have failed fludarabine therapy
　
103767
Ontak
denileukin diftitox
9-Dec-97
5-Feb-99
13.88
S
Treatment of persistent or recurrent cutaneous T-cell lymphoma (orphan indication)
　
103772
Remicade
infliximab
30-Dec-97
24-Aug-98
7.8
S
Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms, in patients who have an inadequate response to conventional therapies and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s)
　
103471
Betaseron
interferon beta-1b
18-Jun-92
23-Jul-93
13.16
　
Treatment of multiple sclerosis (Orphan designation)
　
　
　
　
　
　
　
　
　

* These Therapeutic Biologics Products were transferred from CBER to CDER effective 1-Oct-03







●BLA supplements approved under Subpart E

 - http://www.fda.gov/cder/rdmt/SubpartEBLASupplement.htm; 整列＝承認日順
・ (Updated through 12/31/2005, Posted March 31, 2006)  本資料は四半期毎更新。

ML
STN #
Trade
  Name
Generic
   Name
Receipt
  Date
Approval
  Date
AP Time
Approval
  Basis
Indication
　
BL125011/24.0
Bexxar
tositumomab and iodine I 131 tositumomab
3-Jul-04
22-Dec-04
5.61
S
Expands the indication to include patients with relapsed or refractory, low grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received rituximab
　
　
　
　
　
　
　
　
　












■Fast Track Reports★品目リスト

●Approvals 1998-2005.6.30

Fast Track Designated Products Approved
 - http://www.fda.gov/cder/rdmt/internetftap.htm ; 整列＝承認日順
・ (Updated through 9/30/2005, Posted 11/1/2005)

ML
NDA#
NDA Drug Name
Sponsor Applicant
Approval Date
Indication
　
　
　
　
　
　
●2005
　
BL103772 5113.0
Remicade (infliximab)
Centocor
9/15/2005
Treatment of moderately to severely active ulcerative colitis in patients who had an inadequate response to conventional therapy
　
BL125117
Aryplase (galsulfase)
BioMarin
5/31/2005
Treatment of patients with Mucopolysaccharidosis type VI (MPS-VI)
　
N21737
Retisert (fluocinolone acetonide)
Bausch & Lomb
4/8/2005
Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye
　
BL103964 5039.0
Pegasys(peginterferon alfa-2a)
Hoffmann-La Roche
 2/25/2005
Alone or in combination with ribavirin (Copegus) for treatment of chronic hepatitis C in patients co-infected with HIV, who have clinically stable HIV disease
　
N21841
lamivudine 150mg; zidovudine 300mg tablets co-packaged with nevirapine 200mg tablets
Aspen Pharmacare
1/24/2005*
Treatment of HIV
1208
N21660
Abraxane (paclitaxel protein-bound particles for injectable suspension)
American BioScience
1/7/2005
Treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy
●2004
　
N21673
Clolar (clofarabine)
Genzyme
12/28/2004
Treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens
　
BL125011 24.0
Bexxar (tositumomab and iodine I 131 tositumomab)
Corixa
12/22/2004
Expand the indication to include patients with relapsed or refractory, low-grade, follicular or transformed CD20 positive non-Hodgkin's lymphoma who have not received rituximab
1212
N21756
Macugen (pegaptanib sodium)
Eyetech Pharms
12/17/2004
Treatment of exudative (wet) age-related macular degeneration
1207
BL125103
Kepivance (palifermin)
Amgen
12/15/2004
Decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support
　
N20635 SE1-035
Levaquin (levofloxacin)
Ortho McNeil
11/24/2004
Treatment of inhalational anthrax (post-exposure)
　
N20634 SE1-035
Levaquin (levofloxacin)
Ortho McNeil
11/24/2004
Treatment of inhalational anthrax (post-exposure)
1205
N21743
Tarceva (erlotinib)
OSI Pharms
11/18/2004
Treatment of locally advanced or metastatic Non Small-Cell Lung Cancer after failure of at least one prior chemotherapy regimen
　
N21677
Alimta (pemetrexed)
Lilly
8/19/2004
Treatment of non-small cell lung cancer
1201
N50794
Vidaza (azacitidine)
Pharmion
5/19/2004
Treatment of patients with certain subtypes of myelodysplastic syndrome 
1200
N21264
Apokyn (apomorphine)
Bertek
4/20/2004
Treatment of acute, intermittent hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson’s disease 
　
L125085
Avastin (bevacizumab)
Genentech
2/26/2004
For the first-line treatment of patients with metastatic carcinoma of the colon and rectum (in combination with intravenous 5-fluorouracil-based chemotherapy) 
　
L125084
Erbitux (cetuximab)
ImClone Systems
2/12/2004
Treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy (in combination with irinotecan); treatment of EGFR-expressing, metastatic colorectal carcinoma in patients who are intolerant to irinotecan-based chemotherapy (administered as a single agent) 
　
N21462
Alimta (pemetrexed disodium)
Lilly
2/4/2004
Treatment of malignant pleural mesothelioma 
　
　
　
　
　
　
●1998-2003
1041
N020972
Sustiva (Efavirenz) 50/ 100/ 200MG Caps
Dupont Pharms
9/17/98
Treatment of HIV 
1041
N20977
Ziagen (Abacavir Sulfate) Tablets
Glaxo Wellcome
12/17/98
Treatment of HIV
1041
N20978
Ziagen (Abacavir Sulfate) Oral Solution
12/17/98
1057
N21007
Agenerase (Amprenavir) Caps 50MG/150MG
Glaxo Wellcome
4/15/99
Treatment of HIV
1057
N21039
Agenerase (Amprenavir) 15MG/ML Oral Solution
4/15/99
　
N20449 SE1-011
Taxotere (Docetaxel) IV 80MG/20/MG
Aventis Pharms
12/23/99
For the treatment of locally advanced or metastatic non-small cell lung cancer
1095
N21251
Kaletra (Lopinavir/Ritonavir) Oral Solution
Abbott Labs
9/15/00
Treatment of HIV
1095
N21226
Kaletra (Lopinavir/Ritonavir) Capsule
　
N21248
Trisenox (Arsenic Trioxide) Inj 10MG/10ML
Cell Therapeutics
9/25/00
Treatment of acute promyelocytic leukemia
1108
N021227
Candidas (Caspofungin Acetate) Inj
Merck
1/26/01
Treatment of aspergillus infections for patients who are refractory to or intolerant of other therapies
1106
N021335
Gleevec (Imatinib Mesylate) Capsule
Novartis Pharms
5/10/01
Treatment of Chronic Myeloid Leukemia
　
N21356
Viread (Tenofovir Disoproxil Fumarate)
Gilead
10/26/01
Treatment of HIV
　
N021232
Orfadin (Nitisinone) Capsule
R and R Registration
1/18/02
Treatment of hereditary tyrosinemia type I
1148
N021492
Eloxatin (Oxaliplatin) Injection
Sanofi- Synthelabo
8/9/02
Treatment of colorectal cancer
1152
N20541 SE1-010
Arimadex (Anastrozole) Tablet
AstraZeneca
9/5/02
Adjuvant treatment of early breast cancer in postmenopausal women
1159
N21481
Fuzeon (Enfuviritide)  Lypholized Powder 
Hoffmann LaRoche 
3/13/03 
Treatment of HIV
1160
N21106
Somavert (Pegvisomant) 
Pharmacia and Upjohn 
3/25/03
Treatment of acromegaly
1138
N21399
Iressa (Gefitinib)
AstraZeneca
5/5/03
Treatment of non-small cell lung cancer
1161
N21602
Velcade (Bortesomib)
Millennium Pharms
5/13/03
Treatment of relapsed/refractory multiple myeloma
1169
N21500
Emtriva (Emtricitabine)
Gilead
7/2/03
Treatment of HIV
　
N21348
Zavesca (Miglustat)
Actelion Pharms
7/31/03
Treatment of type I Gaucher disease
　
N21548
Lexiva (fosamprenavir calcium)
GlaxoSmithKline
10/20/2003
Treatment of HIV
　
　
　
　
　
　










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作成：2002.10.6　最終更新:2006.4.2　小菅博之

          The Medical Letter日本語版
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On Drugs and Therapeutics