FDA承認新薬一覧データ:CDER

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～)

●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
・Drug and Biologic Approvals for Calendar Year 2007 (Updated through 6/30/2007, Posted 7/12/2007)
・Drug and Biologic Approvals for Calendar Year 2006 (Updated through 2/28/2006, Posted 3/30/2006)
・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。



●NME Drug and New Biologic Approvals★品目リスト[明細別記]
(New Molecular Entities (NMEs) Reports)
・New Molecular Entities (NMEs) and New Biologic Approvals in Calendar Year 2007
 (Updated through 6/30/2007, Posted 7/12/2007)
・New Molecular Entities (NMEs) and New Biologic Approvals in Calendar Year 2006
 (Updated through 2/28/2006, Posted 3/30/2006)
・New Molecular Entities (NMEs) and New Biologic Approvals in Calendar Year 2005
 (Updated through 12/31/2005, Posted 3/30/2006)
・New Molecular Entities (NMEs) and New Biologic Approvals in Calendar Year 2004
 (Updated through 12/31/2004, Posted 8/11/2005)
・New Molecular Entities (NMEs) Approved in Calendar Year 2003
 (Updated through 12/31/2003, Posted 1/21/2004)
・New Molecular Entities (NMEs) Approved in Calendar Year 2002
 (Updated through 12/31/2002, Posted 1/8/2003)
・New Molecular Entities (NMEs) Approved in Calendar Year 2001
 (Updated through 12/31/2001, Posted 1/7/2002)
 - List of NMEs approved in calendar year 2001.
・New Molecular Entities (NMEs) Approved in Calendar Year 2000 (Updated 4/6/2001)
 - List of NMEs approved in calendar year 2000
・New Molecular Entities (NMEs) Approved in Calendar Year 1999 (Updated 4/6/2001)
 - List of NMEs approved in calendar year 1999.
・New Molecular Entities (NMEs) Approved in Calendar Year 1998 (Updated 4/6/2001)
 - List of NMEs approved in calendar year 1998

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

CDER Priority Drug and Biologic Approvals in Calendar Year 2006[-2006.2.28迄;最終更新2006.3.30]
CDER Priority Drug and Biologic Approvals in Calendar Year 2005
CDER Priority Drug and Biologic Approvals in Calendar Year 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
CDER Priority NDA Approvals in Calendar Year 1999


●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)



●Fast Track Reports★品目リスト[明細別記]
・Approvals 1998-2005.9.30
 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


●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

●CDER Drug and Biologic Approvals for Calendar Year 2006
 By Calendar Year;   NDA & BLA(2004～)
Updated through February 28, 2006; 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 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

　 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

●New Drug Application (NDA) Tentative Approvals

ML NDA NUMBER DRUG NAME GENERIC NAME APPLICANT/
SPONSOR CT RC APPROVAL DATE

　 N021915 ondansetron hydrochloride ondansetron hydrochloride Baxter 3 S 26-May-2006

　 N021714 amlodipine maleate;benazepril hydrochloride amlodipine maleate;benazepril hydrochloride Reddy's Lab 4 S 15-Sep-2006

　 N021915 Ondansetron was tentatively approved on 5/26/2006.
N021714 amlodipine maleate;benazepril hydrochloride was tentatively approved on 9/15/2006

●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

　 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.

●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

　 ●NME and BLA Approved in Calendar Year 2006

Page Last Updated: February 28, 2005; 整列＝承認日順
 New Molecular Entities (NMEs)

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 Approved in Calendar Year 2006
ML NDA Number Proprietary Name Established Name Applicant 分類承認日適応症

　 N021938 Sutent sunitinib malate Pfizer
※ファイザーP1/2 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).

　 ★BLA承認　　　　　　

　　　　　　　　

●NME Approved in Calendar Year 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 Sorafenib Tosylate Bayer
※バイエル薬品P2 P, O 20-Dec-05 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
※日本BMS P1 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

　　　　　　　　

●NME Approved in Calendar Year 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 Erlotinib Hydrochloride OSI Pharms
※中外製薬P2 P 18-Nov-04 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 Pegaptanib Sodium Eyetech Pharms
日本：ファイザーP2/3 P 17-Dec-04 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 Cetuximab ImClone Systems
※日本BMS&メルク P 12-Feb-04 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 Bevacizumab Genentech
※日本：中外 P 26-Feb-04 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 Technetium 99m Tc Fanolesomab Palatin Technologies S 02-Jul-04 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 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 Approved in Calendar Year 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

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

ML	NDA Number	Proprietary Name	Established Name	Applicant	分類	承認日	適応症
●NME Approved in Calendar Year 2006
	N021938	Sutent	sunitinib malate	Pfizer ※ファイザーP1/2	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).
	★BLA承認

●NME Approved in Calendar Year 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	Sorafenib Tosylate	Bayer ※バイエル薬品P2	P, O	20-Dec-05	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 ※日本BMS P1	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

●NME Approved in Calendar Year 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	Erlotinib Hydrochloride	OSI Pharms ※中外製薬P2	P	18-Nov-04	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	Pegaptanib Sodium	Eyetech Pharms 日本：ファイザーP2/3	P	17-Dec-04	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	Cetuximab	ImClone Systems ※日本BMS&メルク	P	12-Feb-04	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	Bevacizumab	Genentech ※日本：中外	P	26-Feb-04	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	Technetium 99m Tc Fanolesomab	Palatin Technologies	S	02-Jul-04	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	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.

ML	NDA Number	Generic Name	Trade Name	Dosage Form	Applicant	分類	Approval Date
●NME Approved in Calendar Year 2003
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