FDA承認新薬一覧データ:CBER

　→●FDA承認新薬一覧データ:CDER　はこちら。　　　但し旧CBER所管生物製剤は、本頁で扱う。　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。 ●2003.6 CBER→CDER移管。　MOAB,免疫療法剤、等。　詳細　移管先ページ※FDA-CDER Drug Approval Reports -http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.ReportsMenu

●Therapeutic Biologic Applications (BLA)

・Approval Information(Labels and Reviews) - ★承認医薬品リスト(最終更新2003.12.12) ・Letters to Industry, Healthcare Providers, and Clinical Investigators -警告レター・Prescription Drug User Fee Act (PDUFA) Billable Products - PDUFA品目一覧・Recalls and Withdrawals ・Research Divisions and Investigators ・What's New for Biologics - ニュース・Safety Information - 安全性情報が要領よく纏まった資料・Violative Advertising and Promotional Labeling Letters ・Important Addresses Investigational New Drug Applications Required Postmarketing Adverse Experience Information Advertising and Promotional Labeling Reports of Biologic Product Deviations Biologic License Applications (BLAs), BLA Supplements, Annual Reports on Postmarketing Studies, Postmarketing Study Final Reports, Postmarketing Study Correspondence, and Distribution Reports
●関連製品　医療用具

　　解説の説明は→●FDA承認新薬一覧データ:CDER　はこちら。 ●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 - CBER: Biological Approvals by Year

- http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicalApprovalsbyYear/default.htm ●Approvals by Year Since 1996　年度別総合 [略] 1996 | 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 ●Biological License Application Approvals　新薬：製品リスト別記 1996 | 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 Last update: 2007.4.24　年月日順 ●Biological License Application Supplement Approvals　追加：製品リスト別記 1996 | 1997 | 1998 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 | 2007 | 2008 | 2009 Last update: 2007.5.8　年月日順 ●CDER移管　生物製剤　[FDA-CDER]Therapeutic Biological Approvals [Last update:2004.4.7] from ●FDA-CDER Biological Therapeutic Products - ・Approval Information(Labels and Reviews) - ★承認医薬品リスト　商品名順　および　承認年月順

●Biological License Application Approvals

　整列＝承認日順; [最終更新2009.10.4] ★個別製品のリンクは資料源が全面変更したため、2006年以前は未訂正。　各年度リンクから辿る必要がある。

●CBER - 2009 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1324
Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
Active immunization as a booster dose for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children 15 months through 4 years of age (prior to fifth birthday). 125347/0
GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617

8/19/2009

　 Source Plasma Shared manufacturing agreement with The Blood Center to freeze and deglycerolize red cells. 125292/0 Medical Center of Louisiana
2021 Perdido St.
New Orleans, LA 70112-1396
License 1800 5/28/2009

　 Source Plasma New manufacturer of source plasma. 125339/0 Octapharma Plasma, Inc.
736 Park North Blvd.
Clarkston, GA 30021
License 1817 5/28/2009

1319 IXIARO
Japanese Encephalitis Vaccine, Inactivated, Adsorbed
For the prevention of disease caused by Japanese encephalitis virus in persons 17 years of age and older 125280/0
Intercell AG
Campus Vienna Biocenter 2
1030 Vienna, Austria
License 1790 3/30/2009

　 ATryn
Antithrombin (Recombinant) For the prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients. 125284/0 GTC Biotherapeutics, Inc.
175 Crossing Blvd.
Framingham , MA 01702
License 1794 2/6/2009

　 RiaSTAP
Fibrinogen Concentrate (Human) For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). 125317/0 CSL Behring GmbH
1020 First Avenue
King of Prussia , PA 19406-0901
License 1765 1/16/2009

●CBER - 2008 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 COBAS TaqScreen MPX Test
Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA Assay For the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) Group M RNA, HIV-1 Group O RNA, Human Immunodeficiency Virus Type 2 (HIV-2) RNA, Hepatitis C Virus (HCV) RNA and Hepatitis B Virus (HBV) DNA in human plasma. 125255/0 Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton , CA 94588-2722
License 1636 12/30/2008

　 Source Plasma New facility in Austin, Texas, FEI 3006605566 125275/0 DCI Biologicals Austin, LLC
5789 Airport Blvd.
Austin , TX 78752
License 1788 12/18/2008

　 Cinryze
C1 Esterase Inhibitor (Human) For routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE). 125267/0 Lev Pharmaceuticals, Inc.
730 Stockton Drive
Exton , PA 19341
License 1780 10/10/2008

　 Source Plasma Acquisition of licensed centers for IBR PlasmaCenters, LLC from International BioResources, Inc. 125322/0 IBR PlasmaCenters, LLC
1200 Camellia Boulevard
Lafayette , LA 70508
License 1808 9/17/2008

　 Source Plasma New manufacturer in San Marcos, TX, FEI 3006521938. 125273/0 DCI Biologicals San Marcos, LLC
1400 IH 35 South
San Marcos , TX 78666
License 1784 9/3/2008

　 Anti-Human Globulin
(Murine Monoclonal)(For Further Manufacturing Use); anti-S (Monoclonal)(For Further Manufacturing Use) For shipment to -----(b)(4)---. 125238/0
125239/0 Millipore ( UK) Ltd.
Fleming Road
Livingston UK EH54 7BN
License 1761 8/14/2008

　 Blood Grouping Reagents, Anti-s (Monoclonal)(IgG)(For Further Manufacturing Use); Anti-P1(Murine Monoclonal)(IgM)(For Further Manufacturing Use); Anti-Fya(Monoclonal)(IgG)(For Further Manufacturing Use); Anti-C(Human Monoclonal)(IgM)(For Further Manufacturing Use) For shipment to -----(b)(4)---. 125209/0
125210/0
125211/0
125236/0 Diagast
Parc Euransante
251, av. Eugene Avinee - BP9
Loos Cedex
France 59374
License 1744 8/14/2008

　 Seraclone
Blood Grouping Reagents and Anti-Human Globulin reagents For the determination of the blood group antigens on red blood cells and detecting in vivo and /or in vitro coating of red blood cells using the tube test 125213/0
125217/0
125219/0
125220/0
125221/0
125222/0
125223/0
125224/0
125225/0
125226/0
125227/0
125228/0
125229/0
125230/0
125231/0
125232/0
125233/0
125215/0
125242/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798 8/14/2008

　 Biotestcell and Erytypecell
Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated Systems Reagent Red Blood Cells are for use in manual tube testing and Reagent Red Blood Cells For Use in Automated Systems are for use on the TANGO(R) optimo automated blood grouping and antibody test system. 125207/0
125208/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798 8/14/2008

　 Erytype S
Blood Grouping Reagents For use on the Erytype(R) S Rh + K Type plate for Rh and Kell typing on the TANGO(R) optimo automated blood grouping and antibody test system 125202/0
125203/0
125204/0
125205/0
125206/0
125218/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798 8/14/2008

　 Seraclone
Blood Grouping Reagent Anti-Fy^a (Monoclonal) For the determination of the blood group antigens on red blood cells using the tube test 125212/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798 8/14/2008

　 Seraclone
Blood Grouping Reagent Anti-s (Monoclonal) For the determination of the blood group antigens on red blood cells using the tube test 125214/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798 8/14/2008

　 Seraclone
Blood Grouping Reagent Anti-S (Monoclonal) For the determination of the blood group antigens on red blood cells using the tube test 125216/0 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798 8/14/2008

　 KINRIX
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children 4 through 6 years of age whose previous DTaP vaccine doses have been with INFANRIX(R) and/or PEDIARIX(R) for the first three doses and INFANRIX(R) for the fourth dose 125260/0 GlaxoSmithKline Biologicals Rue de I'Institut 89
B1330 Rixensart, Belgium
License No. 1617 6/24/2008

　 Pentacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease caused by Haemophilus influenzae type b when administered to infants and children 6 weeks through 4 years of age (prior to fifth birthday) 125145/0 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
Canada
License No. 1726 6/20/2008

　 ROTARIX
Rotavirus Vaccine, Live, Oral Prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children when administered as a two-dose series between the ages of 6-24 weeks 125265/0 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart, Belgium
License 1617 4/3/2008

　 ARTISS
Fibrin Sealant (Human) To adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations 125266/0 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362-3811
License 0140 3/19/2008

　 XYNTHA
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Control and prevention of bleeding episodes and for surgical prophylaxis in patients with hemophilia A. 125264/0 Wyeth Pharmaceuticals, Inc
401 North Middletown Road
Pearl River, NY 10965
License 0003 2/21/2008

　 Red Blood Cells Licensure for CPD/AS-5 RBC and CPD/AS-5 Leukocytes-reduced RBC at St. Lukes Hospital Blood Bank, 1026 A Avenue, NE,Cedar Rapids, IA 52406-3026 (Registration Number 1970362). OTL Mississippi Valley Regional Blood Center U.S. Lic. 366; Reg. No. 3005754990; CLIA 16D038796. 125269/0 St. Luke's Hospital Blood Bank
1026 A Avenue, NE
Cedar Rapids, IA 52406-3026
License 1782 2/20/2008

　 RECOTHROM
Thrombin, topical (Recombinant) An aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical 125248 / 0 ZymoGenetics, Inc
1201 Eastlake Avenue East
Seattle, WA 98102
License 1758 1/17/2008

　 ABBOTT PRISM HTLV-I/HTLV-II
Human T-Lymphotropic Virus Types I and II To be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of anti-HTLV-I/HTLV-II. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor's heart is still beating. 103761 / 0 Abbott Laboratories
D-49C, AP6C/2
100 Abbott Park Road
Chicago, IL 60064
License 0043 1/16/2008

　 OLYMPUS PK System Blood Grouping and Phenotyping Reagents For the in vitro detection and identification of human blood group antigens by direct agglutination 125169/0
125170/0
125171/0
125172/0
125173/0
125174/0
125175/0
125176/0
125177/0
125186/0
125168/0 DIAGAST
251 avenue Eugene Avinee - BP 9
59374 Loos Cedex
FRANCE
License 1744 1/10/2008

●CBER - 2007 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Source Plasma Manufacture of WB, RBC, Autologous WB, Autologous RBC, FFP. 125263/0 Community Blood Center of the Carolinas
4447 South Boulevard
Charlotte, NC 28209
License No. 1774 12/5/2007

　 Afluria
Influenza Virus Vaccine For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine 125254/0 CSL Ltd ACN
45 Poplar Road
Parkville Victoria, 3052
Australia
License No. 1764 9/28/2007

　 ALBAclone Anti A (LA2)/Blood grouping reagent
Anti-A (Murine Monoclonal) Licensure of Anti-A (Murine Monoclonal) from the cell line LA2 125129/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ALBAclone Anti B (LB3/Blood grouping reagent
Anti-B (Murine Monoclonal) Licensure of Anti-B (Murine Monclonal) from cell line LB3 125130/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ALBAclone Anti A,B (LA2/LB3/ES15)/ Blood grouping reagent
Anti-A,B (Murine Monoclonal) Licensure of Anti-A,B (Murine Monoclonal) from the cell lines LA2, LB3, ES15 125131/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-D Alpha (LDM1) (LDM3)/ Blood grouping reagent
Anti-D (Monoclonal) (IgM) Licensure of Blood Grouping Reagents Anti-D (Monoclonal)(IgM) from the cell line LDM1 and from the cell line LDM3 125132/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-E (DEM1)/Blood grouping reagent
Anti-E (Monoclonal) Licensure of Anti-E (Human/Murine Monoclonal) from the cell line DEM1 125133/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-c (H48)/Blood grouping reagent
Anti-c (Monoclonal) Licensure of Anti-c (Human/Murine Monoclonal) from the cell line H48 125134/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-k (cellano) (LKL1)/Blood grouping reagent
Anti-k (Murine Monoclonal) Licensure of Anti-k (cellano)(Murine Monoclonal) from the cell line LKL1 125135/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-M (LM1)/Blood grouping reagent
Anti-M (Murine Monoclonal) Licensure of Anti-M (Murine Monoclonal) from the cell line LM1 125136/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-N (LN3)/Blood grouping reagent
Anti-N (Murine Monoclonal) Licensure of Anti-N (Murine Monoclonal) from the cell line LN3 125137/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-Lea (LEA2)/Blood grouping reagent
Anti-Lea (Murine Monoclonal) Licensure of Anti-Lea (Murine Monoclonal) from the cell line LEA2 125138/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-Leb (LEB2)/Blood grouping reagent
Anti-Leb (Murine Monoclonal) Licensure of Anti-Leb (Murine Monoclonal) from the cell line LEB2 125139/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ABLAclone Anti-Lub (LU2)/Blood grouping reagent
Anti-Lub (Murine Monoclonal) Licensure of Anti-Lub (Murine Monoclonal) from the cell line LU2 125140/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ALBAclone Anti-D Optimun (LDM1/ESD1-M)/Blood grouping reagent
Anti-D (Monoclonal)(IgM Blend) Licensure of Anti-D (Monoclonal)(IgM Blend) from the cell lines LDM1/ESD1-M 125143/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ALBAclone Anti-D Blend (LDM3/ESD1)/Blood grouping reagent
Anti-D (Monoclonal Blend) Licensure of Anti-D (Monoclonal Blend) from the cell lines LDM3/ESD1 125144/0 Alba Bioscience, Inc
801 Capitola Drive, Suite 9
Durham, NC 27703
License No. 1723 9/14/2007

　 ACAM2000
Smallpox (Vaccinia) Vaccine, Live Active immunization against smallpox disease for persons determined to be at high risk for smallpox infection 125158/0 Acambis Inc.
38 Sidney Street
Cambridge, MA 02139
License No. 1733 8/31/2007

　 cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system
West Nile Virus / Nucleic Acid, Pooled Testing/Synthetic [cobas TaqScreen West Nile Virus Test] For the qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor's heart is still beating. 125245/0 Roche Molecular Systems, Inc.
4300 Hacienda Drive
P.O. Box 9002
Pleasanton, CA 94566-0990
License 1636 8/28/2007

　 Evithrom
Thrombin, Topical (Human) An aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical 125247/0 OMRIX Biopharmaceuticals, Ltd.
113 SE 5th St.
Oak Island, NC 28465
License 1603 8/27/2007

　 Privigen
Immune Globulin Intravenous (Human), 10% Liquid For treatment of Primary Immunodeficiency and treatment of chronic Immune Thrombocytopenic Purpura 125201/0 CSL Behring AG
1020 First Avenue
King of Prussia, PA 19406-0901
License 1766 7/26/2007

　 ABBOTT PRISM HCV
Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) For the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in human serum and plasma specimens 103762/0 Abbott Laboratories
D-49C, AP6C/2
100 Abbott Park Road
Chicago, IL 60064
License 0043 7/11/2007

　 Source Plasma S/D/T platelet pheresis, leukocytes reduced and concurrent FFP, using COBE Trima Accel Collection System 125120/0 Cumberland County Hospital System, Inc.
3357 Village Dr
Suite 150
Fayetteville, NC 20304-2000
License 1715 6/21/2007

　 Influenza Virus Vaccine, H5N1 For active immunization of persons 18 through 64 years of age at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine 125244/0 Sanofi Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370
License 1725 4/17/2007

　 HepaGam B
Hepatitis B Immune Globulin Intravenous (Human) For the prevention of Hepatitis B recurrence following liver transplantation in HBsAg-positive liver transplant patients. Also indicated for the treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection. 125237/0 Cangene Corp
155 Innovation Dr.
Winnipeg, Manitoba
Canada
License 1201 4/6/2007

　 CEPROTIN
Protein C Concentrate (Human) For patients with Severe Congenital Protein C Deficiency for the prevention and treatment of venous thrombosis and purpura fulminans 125234/0 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362
License 140 3/30/2007

　 Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay) Detection of Hepatitis C Virus RNA in Human Source Plasma samples by PCR 125101/0 BioLife Plasma Services, L.P.
One Baxter Pkwy
DF3-1E
Deerfield, IL 60015
License 1640 2/9/2007

　 Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay Detection of Human Immunodeficiency Virus RNA in Human Source Plasma samples by PCR 125100/0 BioLife Plasma Services L.P.
One Baxter Pkwy
DF3-1E
Deerfield, IL 60015
License 1640 1/31/2007

　 Source Plasma Merger of 14 different licensed establishments (owned by Grifols) 125250/0 PlasmaCare, Inc.
1128 Main St., Suite 300
Cincinnati, OH 45202
License 1756 1/29/2007

●CBER - 2006 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

Source Plasma For further manufacture 125246 / 0 Talecris Plasma Resources, Inc.
79 T.W. Alexander Dr
4101Research Commons
Research Triangle Park, NC
License 1757 12/20/2006

ORTHO T. cruzi ELISA Test System
Trypanosomacruzi (T. cruzi) Whole Cell Lysate Antigen Donor screening test to detect antibodies to T. cruzi in plasma andserum samples from individual human donors, including donors of wholeblood, blood components or source plasma, and other living donors. It isalso intended for use to screen organ and tissue donors when specimens areobtained while the donor's heart is still beating 125161 / 0 Ortho-Clinical Diagnostics, Inc
1001 US Highway 202
Raritan, NJ08869-0606
License 1236 12/13/2006

Albumin(Human) Restoration and maintenance of circulating blood volume where volumedeficiency has been demonstrated and use of a colloid is appropriate 125154 / 0 Octapharma Pharmazeutika Produktionsgesm.b.H
Oberlaaer Strasse235
A-1100 Vienna, Austria
License 1646 10/17/2006

　 FluLaval
Influenza Virus Vaccine Active immunization of adults 18 years of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine
125163 / 0 ID Biomedical Corporation of Maryland
6996 Columbia Gateway Drive, Suite 103
Columbia , MD 21046-3303
License 1739
10/5/2006

　 Procleix Ultrio
Nucleic Acid Test (NAT) for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA Qualitative in vitro nucleic acid assay system to screen for human immunodeficiency virus type 1 (HIV-1) RNA and hepatitis C virus (HCV) RNA in plasma and serum specimens from individual human donors, including donors of whole blood and blood components, source plasma and other living donors. It is also intended for use in testing plasma and serum specimens to screen organ donors when specimens are obtained while the donor's heart is still beating, and in testing blood specimens from cadaveric (non-heart-beating) donors. 125113 / 0 Gen-Probe, Inc
10210 Genetic Center Drive
San Diego, California 92121
License 1592 10/3/2006

　 ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human)
The ABBOTT PRISM HBsAg is intended to be used as a screening test for individual human donors, including volunteer donors of whole blood and blood components, and other living donors for the presence of HBsAg. It is also intended for use in testing blood and plasma to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (non-heart-beating) donors.
ABBOTT PRISM HBsAg Confirmatory assay is an in vitro qualitative chemiluminescent (ChLIA) used to confirm the presence of hepatitis B surface antigen (HBsAg) in human serum and plasma by means of specific antibody neutralization. The ABBOTT PRISM HBsAg Confirmatory assay is intended for confirmation of samples found to be repeatedly reactive by the ABBOTT PRISM HBsAg assay.
103766 / 0 Abbott Laboratories
D-49C, AP6C/2
100 Abbott Park Road
Chicago, IL 60064
License 0043 7/18/2006

1241-2 GARDASIL
Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Vaccination in females 9 to 26 years of age for prevention of the following diseases caused by Human Papillomavirus (HPV) Types 6, 11, 16, and 18:

Cervical cancer

Genital warts (condyloma acuminata)
and the following precancerous or dysplastic lesions:

Cervical adenocarcinoma in situ (AIS)

Cervical intraepithelial neoplasia (CIN) grade 2 and grade 3

Vulvar intraepithelial neoplasia (VIN) grade 2 and grade 3

Vaginal intraepithelial neoplasia (VaIN) grade 2 and grade 3

Cervical intraepithelial neoplasia (CIN) grade 1

125126 / 0 Merck & Co., Inc
Sumneytown Pike
P.O. Box 4, BLB-22
West Point, PA 19486-0004
License 0002 6/8/2006

1243 Zostavax
Zoster Vaccine, Live, (OKA/MERCK) Prevention of herpes zoster (shingles) in individuals 60 years of age and older when administered as a single-dose 125123 / 0 Merck & Co., Inc
Sumneytown Pike
P.O. Box 4, BLB-22
West Point, PA 19486-0004
License 0002 5/25/2006

　 Source Plasma For further manufacture 125149 / 0 Richmond Blood Plasma, LLC
dba PlasmaCare
117 3rd St
Richmond, VA 23219
License 1729 5/12/2006

1240 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent Prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks 125122 / 0 Merck & Co., Inc
Sumneytown Pike
P.O. Box 4, BLB-22
West Point, PA 19486-0004
License 0002 2/3/2006

　 HepaGam B
Hepatitis B Immune Globulin (Human) Treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection 125035 / 0 Cangene Corp
104 Chancellor Matheson Rd
Winnipeg, Manitoba R3T 5Y3
Canada
License 1201 1/27/2006

1258 Vivaglobin
Immune Globulin Subcutaneous (Human) Treatment of patients with primary immune deficiency (PID) 125115 / 0 ZLB Behring, L.L.C.
1020 First Avenue
King of Prussia, PA 19406-0901
License 1708 1/9/2006

　 Source Plasma For further manufacture 125114 / 0 Whitehall Blood Plasma, LLC
3840 East Main St
Whitehall, Ohio 43213
License 1712 1/5/2006

●CBER - 2005 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Procleix WNV Assay
West Nile Virus Assay Qualitative detection of West Nile Virus (WNV) RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors; testing plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and testing blood specimens to screen cadaveric (non-heart-beating) donors. It is not intended for use on cord blood specimens. 125121 / 0 Gen-Probe Inc
10210 Genetic Center Drive
San Diego, CA 92121
License 1592 12/1/2005

　 ABBOTT PRISM HBcore
Hepatitis B Virus Core Antigen (E.coli, Recombinant) Qualitative detection of total antibody to hepatitis B core antigen (anti-HBc) in human serum and plasma; screening test for blood and plasma to prevent transmission of hepatitis B virus (HBV) to recipients of blood and blood components 103785 / 0 Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064
License 0043 10/13/2005

1244 ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live For vaccination against measles, mumps, rubella, and varicella in children 12 months to 12 years of age 125108 / 0 Merck & Co, Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 9/6/2005

　 Fluarix
Influenza Virus Vaccine For active immunization of adults 18 years of age and older against influenza disease caused by influenza virus types A and B 125127 / 0 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617 8/31/2005

　 Component of Erytype S
Blood Grouping Reagent, Anti-A (Murine Monoclonal); Anti-B (Murine Monoclonal); Anti-A,B (Murine Monoclonal Blend); Anti-D (Monoclonal) (IgM) To perform a single ABO Grouping and D Typing or label confirmation for donor ABO Grouping and/or D Typing (for exclusive use on the Tango Automated Analyzer) 125094 / 0
125095 / 0
125096 / 0
125097 / 0 Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Germany
License 1702 7/26/2005

　 Anti-Human Globulin Solidscreen II
Anti-Human Globulin, Anti-IgG (Rabbit) To detect the sensitization of Reagent Red Blood Cells by immunoglobulins (for exclusive use on the Tango Automated Analyzer) 125098 / 0 Biotest AG
Landsteinerstrasse 5
D-63303 Dreieich
Germany
License 1702 7/26/2005

　 Adacel
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Booster immunization against tetanus, diphtheria and pertussis as a single dose in individuals 11 through 64 years of age 125111 / 0 Aventis Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario
Canada MSR 3T4
License 1280 6/10/2005

　 Tetanus Toxoid Concentrate (For Further Manufacturing Use) For further manufacture to Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with GlaxoSmithKline Biologicals 125107 / 0 Chiron Behring GmbH & Co
P.O. Box 1630
35006 Marburg
Germany
License 1222 5/3/2005

　 Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Booster immunization against tetanus, diphtheria and pertussis as a single dose in adolescents 10-18 years of age 125106 / 0 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617 5/3/2005

　 Vaccinia Immune Globulin Intravenous (Human) treatment and/or modification of the following conditions, which are complications resulting from smallpox vaccination:

Eczema vaccinatum
Progressive vaccinia
Severe generalized vaccinia
Vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions
Aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard
125109 / 0 Cangene Corp
104 Chancellor Matheson Road
Winnipeg, Manitoba
Canada R3T5Y3
License 1201 5/2/2005

　 Gammagard Liquid
Immune Globulin Intravenous (Human), 10% Solution Liquid dosage form for primary immune deficiency 125105 / 0 Baxter HealthCare Corp
One Baxter Way
Westlake Village, CA 91362
License 140 4/27/2005

　 COBAS AmpliScreen HBV Test
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) Qualitative in vitro test for the direct detection of Hepatitis B Virus (HBV) DNA in human plasma from donations of Whole Blood and blood components for transfusion, and Source Plasma, as well as for testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) 125090 / 0 Roche Molecular Systems, Inc
4300 Hacienda Drive
Pleasanton, CA 94588-2722
License 1636 4/21/2005

　 Thrombin (Human) (For Further Manufacturing Use) For further manufacturing with FloSeal Matrix Hemostatic Sealant 125091 / 0 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362
License 0140 2/18/2005

　 Vaccinia Immune Globulin Intravenous (Human) For the treatment and modification of aberrant infections induced by vaccinia virus that include its accidental implantation in eyes (except in cases of isolated keratitis), mouth, or other areas where vaccinia infection would constitute a special hazard; eczema vaccinatum; progressive vaccinia; severe generalized vaccinia, and vaccinia infections in individuals who have skin conditions such as burns, impetigo, varicella-zoster, or poison ivy; or in individuals who have eczematous skin lesions because of either the activity or extensiveness of such lesions 125093 / 0 DynPort Vaccine Company LLC
64 Thomas Johnson Drive
Frederick, MD 21702
License 1700 2/18/2005

　 Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine For active immunization of adolescents and adults 11-55 years of age for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 125089 / 0 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 1/14/2005

●CBER - 2004 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Rhophylac
Rho(D) Immune Globulin Intravenous (Human) Routine antepartum and postpartum prevention of Rho(D) immunization in Rho(D)-negative women, for Rhesus prophylaxis in case of obstetric complications, for Rhesus prophylaxis in case of invasive procedures during pregnancy, and for the suppression of Rhesus immunization in Rho(D)-negative individuals transfused with Rho(D)-positive red blood cells (RBCs) or blood components containing Rho(D)-positive RBCs 125070 / 0 ZLB Bioplasma AG
-Attention: Richard Peck, Ph.D.,Head, Regulatory Affairs, Wankdorfstrasse 10, Postfach, 3000 Bern 22, Switzerland; License 1598 2/12/2004

　 OCTAGAM
Immune Globulin Intravenous (Human) Treatment of primary immune deficient diseases 125062 / 0 OCTAPHARMA Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235, A-1100, Vienna, Austria; License 1646 5/21/2004

　
　　　　

●CBER - 2003 Biological License Application Approvals - Approvals through December

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Source Plasma For further manufacturing 125064 / 0 International BioResources, LLC
7428 E. Stetson Drive
Suite 110
Scottsdale, AZ 85251
License 1655 3/13/2003

　 Crosseal
Fibrin Sealant (Human) Adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical 125010 / 0 OMRIX biopharmaceuticals, Ltd.
200 Chaussee De Waterloo
1640 Rhode-St-Genese, MA 02142
BELGIUM
License 1603 3/21/2003

　 ORTHO Antibody to HBsAG ELISA Test System 3
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) (Antibody to HBsAg/Enzyme Immuno Assay (EIA), Version 3.0/Monoclonal) Detection of hepatitis B surface antigen in human serum or plasma as a screening test and an aid in the diagnosis of potential hepatitis B infection 103901 / 0 Ortho-Clinical Diagnostics, Inc
1001 U.S. Highway 202
P.O. Box 350
Raritan, NJ 08869-0606
License 1236 4/23/2003

1163 FluMist
Influenza Virus Vaccine, Live, Intranasal For active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5-17 years of age, and healthy adults, 18-49 years of age 125020 / 0 MedImmune Vaccines, Inc
297 North Bernardo Ave
Mountain View, CA 94043
License 1652 6/17/2003

　 Zemaira
Alpha-1-Proteinase Inhibitor (Human) Chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor deficiency and evidence of emphysema 125078 / 0 Aventis Behring L.L.C.
1020 First Avenue
P.O. Box 61501
King of Prussia, Pennsylvania 19406-0901 License 1281 7/8/2003

　 Advate
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method (rAHF-PFM) Indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes. Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method is also indicated in the perioperative management of patients with hemophilia A. 125063 / 0 Baxter Healthcare Corp
One Baxter Way
Westlake Village, California 91362
License 0140 7/25/2003

　 Genetic Systems HIV-1/HIV-2 Plus O EIA
Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic) For detection of antibodies to human immunodeficiency types 1 and 2 125030 / 0 Bio-Rad Laboratories, Inc
4000 Alfred Nobel Drive
Hercules, CA 94547
License 1109 8/5/2003

　 Source Plasma For further manufacturing 125071 / 0 Portsmouth Blood Plasma, LLC
1128 Main Street
Cincinnati, OH 45202
License 1658 8/7/2003

　 Source Plasma For further manufacturing 125032 / 0 BSC II
3218 Azeele Street
Tampa, FL 33609
License 1619 8/11/2003

　 Gamunex
Immune Globulin Intravenous (Human), 10% by Chromatography Process Indicated in primary humoral immunodeficiency and idiopathic thrombocytopenic purpura 125046 / 0 Bayer Corporation
800 Dwight Way
Berkeley, California 94710
License 0008 8/27/2003

　 BabyBIG
Botulism Immune Globulin Intravenous (Human) Treatment of infant botulism caused by type A or type B Clostridium botulinum 125034 / 0 California Department of Health Services
Cato Research, Ltd
200 Westpark Corporate Center
Durham, NC 22713-2280
License 1622 10/23/2003

　 Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Primary and booster immunization of persons 7 - 59 years of age against tetanus and diphtheria 103171 / 0 Aventis Pasteur Ltd
1755 Steeles Avenue West
Toronto, Ontario
License 1280 11/3/2003

　 Source Plasma For further manufacturing 125079 / 0 Hampton Blood Plasma, LLC
1128 Main Street
Cincinnati, OH 45202
License 1686 12/8/2003

　 Flebogamma
Immune Globulin Intravenous (Human) Replacement therapy in primary (inherited) humoral immune deficiency disorders 125077 / 0 Instituto Grifols, SA
Barcelona, Spain
License 1181 12/15/2003

　
　　　　

●CBER - 2002 Biological License Application Approvals - Approvals through December

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Procleix
HIV-1 / HCV Assay Assay for the qualitative detection of human immunodeficiency virus type 1 and/or hepatitis C virus RNA in human plasma from donations of whole blood and blood components for transfusion 103966/0 Gen-Probe, Inc
10210 Genetic Center Drive
San Diego, CA 92121
License 1592 2/27/2002
　 DAPTACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) Active immunization of infants and toddlers at 2, 4, 6, and 17-20 months of age against diphtheria, tetanus and pertussis 103666/0 Aventis Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4 CANADA
License 1280 5/14/2002

　 Multiple Products:
Human Blood and Blood Components Transfusion/For Further Manufacture 125037/0 DCI Biologicals Jonesboro, Inc
2309A East Nettleton
Jonesboro, AR 72401
License 1625 7/10/2002

　 Source Plasma For Further Manufacture 125055/0 DCI Biologicals Inc
Greenville, NJ 07110-1199
License 1645 10/29/2002

　 Source Plasma For Further Manufacture 125054/0 Marion Blood Plasma, Inc
3620 North Post Road
Indianapolis, IN 46226
License 1643 11/19/2002

　 COBAS AmpliScreen HCV Test
Hepatitis C Virus Assay Detecting HCV RNA, in conjunction with licensed test for detecting antibodies to HCV 125045 Roche Molecular Systems, Inc
P.O. Box 9002
4300 Hacienda Drive
Pleasanton, California 94566-0990
License 1636 12/3/2002

1156 Pediarix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Active immunization against diphtheria, tetanus, pertussis (whooping cough), all known subtypes of hepatitis B virus, and poliomyelitis caused by poliovirus Types 1, 2, and 3 103907 SmithKline Beecham Biologicals
89, rue de l'Institute
B-1330 Rixensart
BELGIUM
License 1090 12/13/2002

　 COBAS AmpliScreen HIV-1 Test
Human Immunodeficiency Virus Type 1 Qualitative in vitro test for direct detection of HIV-1 RNA in human plasma from donations of whole blood and blood components for transfusion 125059 Roche Molecular Systems, Inc
P.O. Box 9002
4300 Hacienda Drive
Pleasanton, California 94566-0990
License 1636 12/20/2002

　 Aralast
Alpha-1 Proteinase Inhibitor (Human) Treatment for chronic replacement therapy (augmentation) in patients having congenital deficiency of Alpha-1-Proteinase Inhibitors with clinically evident emphysema 125039 / 0 Alpha Therapeutic Corp
5555 Valley Blvd,Los Angeles, CA 90032; License 0744 12/23/2002

●CBER - 2001 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Multiple Products:
Human Blood and Blood Components Transfusion/For Further Manufacture 125026/0 DCI Biologicals Flagstaff, Inc
1706 South 2nd Street
Gallup, NM 87301
License 1612 1/17/2001

　 Multiple Products:
Human Blood and Blood Components Transfusion/For Further Manufacture 103903/0 DCI Biologicals Orlando, Inc
22 West Lake Beauty Drive
Orlando, FL 32806
License 1286 1/19/2001

1110 TWINRIX
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine Active immunization of persons 18 years of age or older against disease caused by hepatitis A virus and infection by all known subtypes of hepatitis B virus 103850/0 SmithKline Beecham Biologicals
89, Rue de l'Institut
B-1330 Rixensart
BELGIUM
License 1090 5/11/2001

　 Multiple Products: Human Blood and Blood Components Transfusion / For Further Manufacture 103952/0 Coral Blood Services
300 Professional Drive
Scarborough, ME 04074
License 1590 5/22/2001

　 Multiple Products: Human Blood and Blood Components Transfusion / For Further Manufacture 103965/0 DCI Biologicals Nacogdoches, Inc
1706 S. 2nd Street
Gallup, NM 87301
License 1591 7/10/2001

　 DigiFab
Digoxin Immune Fab (Ovine) Treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose 103910/0 Protherics Inc
1207 17th Avenue S., Suite 103
Nashville, TN 37212
License 1575 8/31/2001

　 UltraQualä
HCV RT-PCR Assay
UltraQualä
(Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay A nucleic acid test used to detect HCV-RNA in pooled human Source Plasma 103868/0 National Genetics Institute 2440 S. Sepulveda Blvd. #130
Los Angeles, CA 90064
License 1582 9/18/2001

　 UltraQualä
HIV-1 RT-PCR Assay
UltraQualä
Human Immunodeficiency Type 1 Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay A nucleic acid test used to detect HIV-1-RNA in pooled human Source Plasma 103902/0 National Genetics Institute
2440 S. Sepulveda Blvd. #130
Los Angeles, CA 90064
License 1582 9/18/2001

　 Multiple Products:
Human Blood and Blood Components Transfusion/For Further Manufacture 103793/0 Central Pennsylvania Blood Bank
Liberty Centre Office Complex
8170 Adams Drive, Suite 100
Hummelstown, PA 17036
License 1576 10/12/2001

　 Nabi-HB
Hepatitis B Immune Globulin (Human) Treatment of acute exposure to HBsAg following acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons, and household exposure of infants to persons with acute hepatitis B virus infection 103945/0 Nabi
5800 Park of Commerce Blvd, NW
Boco Raton, FL 33487
License 1022 10/23/2001

　 Multiple Products:
Human Blood and Blood Components Transfusion/For Further Manufacture 125040/0 Price Hill Blood Plasma, Inc
3711 Warsaw Avenue
Cincinnati, OH 45210
License 1621 12/4/2001

●CBER - 2000 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1074 Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Immunization of infants 2, 4, 6 and 12-15 months of age to prevent invasive pneumococcal disease Lederle Laboratories Division
American Cyanamid Company
401 N. Middletown Road
Pearl River, NY 10965
License 0017 2/17/2000

　 ReFacto
Antihemophilic Factor (Recombinant) Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A Genetics Institute, Inc.
One Burtt Road
Andiver, MA 01810-5901
License 1163 3/6/2000

　 PACIS
BCG, Live Treatment of carcinoma-in-situ (CIS) in the absence of associated invasive cancer of the bladder BioChem Pharma Inc.
2323 Parc Technologique Blvd.
Sainte-Foy, Quebec
Canada
License 1283 3/9/2000

　 Plasma Transfusion Rex Hospital, Inc.
4420 Lake Boone Trail
Raleigh, NC
License 0748 3/10/2000

　 Platelets Transfusion Rex Hospital, Inc.
4420 Lake Boone Trail
Raleigh, NC
License 0748 3/10/2000

　 ID Micro Typing Systems
Anti-A (Murine Monoclonal) In vitro test/antigen detection; monoclonal antibody, derived from the BIRMA-1 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals LTD 103787/0 Micro Typing Systems, Inc.
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177 9/21/2000

　 ID Micro Typing Systems
Anti-B (Murine Monoclonal) In vitro test/antigen detection; monoclonal antibody, derived from the LB-2 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals LTD 103789/0 Micro Typing Systems, Inc.
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177 9/21/2000

　 ID Micro Typing Systems
Anti-A and B (Murine Monoclonal); Anti-A,B (Murine Monoclonal) In vitro test/antigen detection; monoclonal antibody, derived from the ES-15 & ES-4 cell lines, in MTS Gel Cards under a shared manufacturing agreement with Serologicals LTD 103790/0 Micro Typing Systems, Inc.
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177 9/21/2000

　 ID Micro Typing Systems
Anti-D (Human Monoclonal) (IgM) In vitro test/antigen detection; monoclonal antibody, derived from the MS-201 cell line, in MTS Gel Cards under a shared manufacturing agreement with Serologicals LTD 103791/0 Micro Typing Systems, Inc.
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177 9/21/2000

1107 Crofab
Crotalidae Polyvalent Immune Fab (Ovine) Treatment of minimal and moderate North American Crotalidae envenomation 103788/0 Protherics, Inc.
(a wholly-owned subsidiary of Protherics PLC)
1207 17 ^th Avenue S., Suite 103
Nashville, TN 37212
License 1575 10/02/2000

●CBER - 1999 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Whole Blood Transfusion Winter Haven Hospital, Inc.
460 First Street, North
Winter Haven, FL 33881
License 1266 02/05/1999

　 Red Blood Cells Transfusion Winter Haven Hospital, Inc.
460 First Street, North
Winter Haven, FL 33881
License 1266 02/05/1999

　 Plasma Transfusion Winter Haven Hospital, Inc.
460 First Street, North
Winter Haven, FL 33881
License 1266 02/05/1999

　 Nabi-HB
Hepatitis B Immune Globulin (Human) Treatment of acute exposure to HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure of infants to persons with acute HBV infection Nabi
P.O. Box 310701
Boca Raton, FL 33431-0701
License 1022 03/24/1999

1181 NovoSeven
Coagulation Factor VIIa (Recombinant) Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX Novo Nordisk A/S
Novo Alle
DK-2880 Bagsvaerd
DENMARK
License 1261 03/25/1999

　 Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human) Used in adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia); in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease; and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate Centeon Pharma G.m.b.H.
P.O. Box 1230
D-35002 Marburg
GERMANY
License 1202 04/01/1999

　 Cryoprecipitated AHF Transfusion Sarasota Community Blood Bank, Inc.
1760 Mound Street
Sarasota, FL 34236-7761
License 1122 06/14/1999

　 Plasma Transfusion Marathon County Blood Bank, Inc.
404 South 3rd Avenue
Wausau, WI 54401
License 1093 07/16/1999

　 Cryoprecipitated AHF Transfusion Northern California Community Blood Bank
2524 Harrison Avenue
Eureka, CA 95501
License 0230 07/28/1999

　 Cryoprecipitated AHF Transfusion Central California Blood Center
3445 North First Street
Fresno, CA 93726
License 0315 08/12/1999

　 Source Plasma For further manufacture DCI Biologicals Bryan, Inc.
1706 South 2nd St.
Gallup, NM 87301
License 1275 08/13/1999

　 Plasma Transfusion Northern California Community Blood Bank
2524 Harrison Avenue
Eureka, CA 95501
License 0230 08/16/1999

　 Platelets Transfusion Marathon County Blood Bank, Inc.
404 South Third Avenue
Wausau, WI 54401-4639
License 1093 09/17/1999

　 Whole Blood Transfusion Community Blood Center
Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276 12/17/1999

　 Red Blood Cells Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276 12/17/1999

　 Platelets Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276 12/17/1999

　 Cryoprecipitated AHF Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276 12/17/1999

　 Plasma Transfusion Community Blood Center Of the Ozarks
2230 S. Glenstone
Springfield, MO 65804
License 1276 12/17/1999

　 Source Plasma For further manufacture PlasmaCare, Inc.
1128 Main Street
Cincinnati, OH 45210
License 1278 12/30/1999

●CBER - 1998 Biological License Application Approvals

　 Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Source Plasma For further manufacture Community Blood Centers of South Florida, Inc.
1700 North State Rd. 7
Lauderhill, FL 33313
License 0913 01/06/1998

　 Source Plasma For further manufacture Seramed, Inc.
780 Park North Blvd.
Clarkston, GA 30021
License 1237 01/16/1998

　 HTLV-I p21E Antigen
Human T-Lymphotropic Virus I & II Shared manufacturing arrangement with Organon Teknika Corporation Organon Teknika B.V.
Boseind 15 5281 RM
Boxtel, NETHERLANDS
License 1103 01/17/1998

　 Vironostika HTLV-I & II Microelisa System
Human T-Lymphotropic Virus I & II Used for detection of antibodies to HTLV-I/II in human serum or plasma Organon Teknika Corporation
100 Akzo Avenue
Durham, NC 27712
License 0956 01/17/1998

　 Whole Blood Transfusion Dept. of Veterans Affairs
Medical and Regional Office Center Blood Bank Dept.
1 VA Center
Togus, ME 04330
License 1240 03/19/1998

　 Tisseel VH Kit
Fibrin Sealant Used as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by onventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical; and for closure of colostomies Osterreichisches Institut fur Haemoderivate Ges.m.b.H.
Industriestrasse 67
A-1220 Vienna
AUSTRIA License 0258 05/01/1998

　 VIPLAS/SD
Pooled Plasma, Solvent Detergent Treated For use in the treatment of patients with documented deficiencies of coagulation factors for which there are no concentrate preparations available, including congenital single-factor deficiencies of factors I, V, VII, XI, and XIII, and acquired multiple coagulation factor deficiencies; reversals of warfarin effect; and treatment of patients with thrombotic thrombocytopenic purpura (TTP) V.I. Technologies, Inc.
155 Duryea Road
P.O. Box 5119
Melville, NY 11747
License 0386 05/06/1998

　 Source Plasma For further manufacture V.I. Technologies, Inc.
155 Duryea Road
P.O. Box 5119
Melville, NY 11747
License 0386 05/12/1998

　 Source Plasma For further manufacture International Enzymes, Inc.
1432-B South Mission Road
Fallsbrook, CA 92028
License 1243 05/27/1998

　 Source Leukocytes For further manufacture San Diego Blood Bank
440 Upas Street
San Diego, CA 92103
License 0201 06/26/1998

　 CERTIVA
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed For the active immunization of persons 6 weeks to 7 years of age (prior to the seventh birthday) North American Vaccine, Inc.
12103 Indian Creek Court
Beltsville, MD 20705
License 1254 07/29/1998

　 Diphtheria Toxoid Concentrate (For Further Manufacturing Use) For further manufacture under shared arrangement with North American Vaccine, Inc. Statens Seruminstitut
5, Artillerivej
DK-2300
Copenhagen S
DENMARK
License 1255 07/29/1998

　 Tetanus Toxoid Concentrate (For Further Manufacturing Use) For further manufacture under shared arrangement with North American Vaccine, Inc. Statens Seruminstitut
5, Artillerivej
DK-2300
Copenhagen S
DENMARK
License 1255 07/29/1998

　 Source Plasma For further manufacture San Diego Blood Bank
440 Upas Street
San Diego, CA 92103
License 0201 08/19/1998

1053 RotaShield
Rotovarus Vaccine, Live, Oral, Tetravalent Primary immunization of infants at 2, 4, and 6 months of age Wyeth Laboratories, Inc.
Wasp & Biddle Streets
P.O. Box 34
Marietta, PA 17547
License 0003 08/31/1998

　 Cryoprecipitated AHF Transfusion Northern Illinois Blood Bank, Inc.
419 North Sixth Street
Rockford, IL 61107
License 0249 09/01/1998

　 Red Blood Cells Transfusion Arizona Blood Institute, Inc.
3915 East Broadway Blvd
Tucson, AZ 86711
License 1225 10/08/1998

　 Source Plasma For further manufacture West Tennessee Regional Blood Center, Inc.
828 North Parkway
Jackson, TN 38305
License 0170 11/04/1998

　 Whole Blood Transfusion Central Illinois Community
Blood Bank
1134 South Seventh Street
Springfield, IL 62703
License 1263 12/17/1998

　 Red Blood Cells Transfusion Central Illinois Community
Blood Bank
1134 South Seventh Street
Springfield, IL 62703
License 1263 12/17/1998

　 Platelets Transfusion Central Illinois Community
Blood Bank
1134 South Seventh Street
Springfield, IL 62703
License 1263 12/17/1998

1049 LYMErix
Lyme Disease
Vaccine (Recombinant OspA) Active immunization against Lyme disease in individuals aged 15-70 years SmithKline Beecham
Biologicals
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM
License 1090 12/21/1998

　 Whole Blood Transfusion Gateway Community Blood
Program, Inc.
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264 12/24/1998

　 Red Blood Cells Transfusion Gateway Community Blood
Program, Inc.
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264 12/24/1998

　 Plasma Transfusion Gateway Community Blood
Program, Inc.
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264 12/24/1998

　 Platelets Transfusion Gateway Community Blood
Program, Inc.
1800 Craigshire Drive
St. Louis, MO 63146-4006
License 1264 12/24/1998

　 Thymoglobulin
Anti-thymocyte Globulin (Rabbit) Treatment of acute rejection in renal transplant patients Pasteur Meriex Serums et
Vaccins, S.A.
58 Avenue Leclerc
69007 Lyon, FRANCE
License 0384 12/30/1998

●CBER - 1997 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Source Plasma For further manufacture Nations Biologics,Inc.
1900 Lafayette St.
Gretna, LA 70053
License 1221 01/17/1997

　 Diphtheria &Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) For further manufacture under shared arrangement with SmithKline Beecham Biologicals Chiron Behring GmbH & Co.
P.O. Box 1630
35006 Marburg GERMANY
License 1222 01/29/1997

　 Infanrix
Diphtheria &Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed For primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses SmithKline Beecham
Biologicals, S.A.
89, Rue de l'Institut
1330 Rixensart
BELGIUM
License 1090 01/29/1997

　 Red Blood Cells Transfusion Am-Rho Labs., Inc.
780 Park North
Boulevard, #110
Clarkston, GA
License 0991 02/10/1997

　 Benefix
Coagulation Factor IX (Recombinant) Control and Prevention of hemorrhagic episodes in patients with hemophilia B, including the perioperative management of hemophilia B patients undergoing surgery Genetics Institute,Inc.
1 Burtt Road
Andover, MA
License 1163 02/11/1997

　 Cryoprecipitated AHF Transfusion Spartanburg Blood Bank, Inc.
175 Dunbar Street
Spartanburg, SC
License 0765 02/18/1997

　 Source Plasma For further manufacture Joliet Blood Plasma, L.L.C.
502 N. Capitol Ave.
Indianapolis, IN 46204
License 1223 03/03/1997

　 Platelets Transfusion South Bend Medical Foundation, Inc.
530 N. Lafayette Blvd.
South Bend, IN 46601
License 0248 03/07/1997

　 Source Plasma For further manufacture SeraCare Acquisitions,Inc.
1925 Century Park East
Los Angeles, CA 90067
License 1224 03/19/1997

　 Platelets Transfusion Arizona Blood Institute, Inc.
3915 E. Broadway Blvd.
Tucson, AZ 85711
License 1225 03/20/1997

　 Plasma Transfusion Arizona Blood Institute, Inc.
3915 E. Broadway Blvd.
Tucson, AZ 85711
License 1225 03/20/1997

　 Diphtheria & Tetanus Toxoids Adsorbed Immunization of infants and children, 6 weeks to 7 years of age Connaught Labs. Ltd.
1755 Steeles Avenue
West North York, Ontario,
CANADA M2R 3T4
License 0073 04/11/1997

　 Source Plasma For further manufacture The Canadian Red Cross Society
1800 Alta Vista Drive
Ottawa, ON KIG 4J5
CANADA
License 1226 05/01/1997

　 Whole Blood Transfusion United States Blood Bank, Inc.
130 Ponce de Leon Blvd.
Coral Gables, FL 33135
License 1229 06/23/1997

　 Red Blood Cells Transfusion United States Blood Bank, Inc.
130 Ponce de Leon Blvd.
Coral Gables, FL 33135
License 1229 06/23/1997

　 Plasma Transfusion United States Blood Bank, Inc.
130 Ponce de Leon Blvd.
Coral Gables, FL 33135
License 1229 06/23/1997

　 Source Plasma For further manufacture Melrose Plasma, L.L.C.
105 Chapel Drive
Lafayette, LA 70506
License 1230 08/07/1997

　 Plasma Transfusion Serologicals, Inc.
780 Park North Blvd.
Clarkston, GA 30021
License 0963 08/07/1997

　 Red Blood Cells Transfusion Serologicals, Inc.
780 Park North Blvd.
Clarkston, GA 30021
License 0963 08/07/1997

　 Whole Blood Transfusion Serologicals, Inc.
780 Park North Blvd.
Clarkston, GA 30021
License 0963 08/07/1997

　 Abbott HTLV-I
HTLV-III EIA
Human T-Lymphotropic Virus Types I and II EIA for detection of HTLV-I/HTLV-II antibodies in serum or plasma Abbott Laboratories
D-49C, AP6C/2 Abbott Park,
Buckley Rd.& Waukegan Road
North Chicago, IL 60064
License 0043 08/15/1997

　 Carticel SM Service
Autologous Cultured Chondrocytes Repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle Genzyme Tissue Repair
64 Sidney Street
Cambridge, MA 02139
License 1233 08/22/1997

　 Source Plasma For further manufacture DCI Biologicals
764 Main Street
Dunedin, FL
License 1234 10/09/1997

1029 RabAvert
Rabies Vaccine Rabies vaccine for immunization of children and adults Chiron Behring GmbH
P.O. Box 1630
35006 Marburg,
GERMANY
License 1222 10/20/1997

　 Source Leukocytes For further manufacture Serologicals, Inc.
780 Park North Blvd.,Suite 110
Clarkston, GA 30021
License 0963 12/09/1997

●CBER - 1996 Biological License Application Approvals

　 Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Blood Grouping Reagent (Monoclonal)(For Further Manufacturing Use) Shared manufacturing arrangement with Immucor, Inc. Sanofi Diagnostics Pasteur, S.A.
Parc Hightec 9 Avenue du Canada Batiment LATITUDE-B.P.354
91966 LES ULIS CEDEX
FRANCE
License 1198 01/03/1996

　 Respigam
Respiratory Syncytial Virus Immune Globulin Intravenous (Human) Prevention of serious lower respiratory tract infection in children less than 24 months of age Massachusetts Public Health Biologic Labs 305 South Street Boston, MA 02130
License 0064 01/18/1996

　 Source Plasma For further manufacture BioMune Corporation
Post Office Box 310701
Boca Raton, FL 33431-0701
License 1200 02/05/1996

　 Red Blood Cells Transfusion South Bend Medical Foundation, Inc.
530 N. Lafayette Blvd.
South Bend, IN 46601
License 0248 03/05/1996

　 Plasma Transfusion Community Blood Bank of Lancaster County
Medical Society
2966 "O" Street
Lincoln, NE 68510
License 0695 03/05/1996

　 Coulter HIV-1 p24 Antigen Assay Neutralization Kit Antibody to HIV-1 p24 Antigen (Murine Monoclonal) In-vitro diagnostic test kit used in the detection of HIV Type 1 Antigen Coulter Corporation
MC 31-B06,
P.O. Box 169015
Miami, FL 33116-9015
License 1185 03/14/1996

　 Plasma Transfusion Blood Bank of the Redwoods
2324 Bethards Dr.
Santa Rosa, CA 95405-8537
License 0197 3/15/1996

　 VAQTA
Heptatitis A Vaccine Inactivated Immunization against hepatitis A in children over 6 years of age Merck & Co., Inc.
Sumneytown Pike
West Point, PA 19486
License 0002 03/29/1996

　 Reverse-Cyte
Reagent Red Blood Cells In vitro diagnostic test kit Dade AG
Bonnstrasse 9
3186 Dudingen
SWITZERLAND
License 1138 04/03/1996

　 Platelets Transfusion Blood Bank of San Bernardino and Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License 0226 04/25/1996

　 Source Leukocytes Transfusion Florida Georgia Blood Blood Alliance, Inc.
536 West 10th Street
Jacksonville, FL 32206
License 0181 05/06/1996

　 Source Plasma For further manufacture Green Street Biologicals, Inc.105 Chapel Drive
Lafayette, LA 70506
License 1203 05/06/1996

　 Cryoprecipitated AHF Transfusion Central Blood Bank
812 Fifth Avenue
Pittsburgh, PA 15219
License 0234 06/26/1996

　 Cryoprecipitated AHF Transfusion Civitan Regional Blood Center, Inc.
1221 NW 13th Street
Gainesville, FL 32601
License 0843 06/26/1996

　 Immu-4 Bulk
(For Further Manufacturing Use) Shared manufacturing arrangement with Immunomedics, Inc. Charles River Div.of Wilmington Partners, L.P.
251 Ballardvale Street
Wilmington, MA 01887
License 1206 06/28/1996

　 CEA-Scan
Arcitumomab Imaging agent used in the detection of colorectal carcinoma Immunomedics, Inc.
300 American Road
Morris Plains, NJ 07950
License 1205 06/28/1996

　 Myoscint
Imciromab Pentetate Cardiac imaging agent for detection of myocardial necrosis Centocor B.V.
2300 AG Leiden
Einsteinweg 101
P.O. Box 251
NETHERLANDS
License 1178 07/03/1996

　 Plasma Transfusion Blood Bank of San Bernardino and Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License No 0226 08/06/1996

　 Calypte HIV-1
Urine EIA
HIV-Type 1 (Recombinant) In vitro diagnostic test kit used in the detection of antibodies to HIV-1 present in urine Calypte Biomedical Corp
1440 Fourth Street,
Berkeley, CA 94701
License 1207 08/06/1996

　 Antihemophilic Factor (Human) Treatment of patients with hemophilia A Centeon Pharma GmbH
Post Office Box 1230
D-35002 Marburg
GERMANY
License 1202 08/22/1996

　 Plasma Transfusion Am-Rho Laboratories,Inc
780 N. Park Blvd.Suite 100
Clarkston, GA 30021
License 0991 08/22/1996

　 Therapeutic Exchange Plasma Collection of plasma from patients diagnosed with Guillain-Barre and who have developed high titers of IgM antibody to Cytomegalovirus Community Blood Center of Greater Kansas City
4040 Main Street
Kansas City, MO 64111
License 0302 09/03/1996

　 Whole Blood Transfusion Sitka Community Hosp.
209 Moller Street
Sitka, AK 99835
License 1210 09/03/1996

　 RSV High Titer Fraction II+III Paste (For Further Manufacturing Use) Shared manufacturing arrangement with Massachusetts Public Health Biologic Labs Baxter Heathcare Corp.
305 South Street
Boston, MA 02130
License 0140 09/10/1996

　 COMVAX
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine Immunization of persons 6 weeks to 15 months of age born of Hepatitis B Surface Antigen (HBsAg) negative mothers Merck & Co., Inc.
Sumneytown Pike
West Point, PA 19486
License No. 0002 10/02/1996

　 Cryoprecipitated AHF Control bleeding associated with Factor VIII deficiency Blood Bank of the Redwoods
2324 Bethards Drive
Santa Rosa, CA
95405-8537
License No. 0197 10/03/1996

　 Whole Blood Transfusion South East Alaska Regional Health Consortium
222 Tongass Drive
Sitka, AK 99835
License No. 1212 10/10/1996

　 Whole Blood Transfusion Littleton Regional Hospital
107 Cottage Street
Littleton, NH 03561
License No. 1213 10/10/1996

　 Red Blood Cells Transfusion Littleton Regional Hosptial 107 Cottage Street
Littleton, NH 03561
License No. 1213 10/10/1996

　 Source Plasma For Further Manufacture Decatur Plasma, Inc.
105 Chapel Drive
Lafayette, LA 70506
License No. 1214 10/21/1996

　 Source Plasma For Further Manufacture Atopix Pharma.Corporation
5375 Avenida Encinas
Suite B
Carlsbad, CA 92008
License No. 1215 10/21/1996

　 Source Leukocytes Transfusion The Blood Center of New Jersey, Inc.
45 South Grove St.
East Orange, NJ 07018
License 0221 11/13/1996

　 Plasma Transfusion Puget Sound Blood Center
921 Terry Avenue
Seattle, WA 98104
License 0192 11/21/1996

　 Source Plasma For further manufacture Clinical Research Technologies
12095 W. Washington Boulevard
Los Angeles, CA 90066
License 1217 12/11/1996

　 UB1 HIV1/2 EIA
Human Immuno-deficiency test to detect Virus Types 1 & 2 In vitro diagnostic antibodies to HIV1/2 in human serum or plasma United Biomedical, Inc.
25 Davids Drive
Hauppauge, NY 11788
License 1079 12/20/1996

　 Cryoprecipitated AHF Transfusion Blood Bank of San Bernardino and Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License 0226 12/26/1996

　 Cryoprecipitated AHF Transfusion Blood Bank of San Bernardino and Pooled Riverside Counties
384 Orange Show Road
San Bernardino, CA 92412
License 0226 12/26/1996

　 Source Plasma For further manufacture Cal Plasma Center,L.L.C.
105 Chapel Drive
Lafayette, LA 70506
License 1219 12/26/1996

　 Cryoprecipitated AHF Transfusion Inova Health Care Services
3289 Woodburn Road,
Suite 10
Annandale, VA 22003
License 0365 12/26/1996

　 Source Plasma For further manufacture SeraCare, Inc.
1925 Century Park, East, Suite 1970
Los Angeles, CA 90067
License 1218 12/26/1996

●Biological License Application Supplement Approvals

整列＝承認日順：　Last update: 2009.10.4
★個別製品のリンクは資料源が全面変更したため、2006年以前は未訂正。　各年度リンクから辿る必要がある。

●CBER - 2009 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Influenza A (H1N1) 2009 Monovalent Active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. 125254/127 CSL Limited 9/15/2009

　 Influenza A (H1N1) 2009 Monovalent Active immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus. 125020/1215 MedImmune LLC 9/15/2009

　 Influenza A (H1N1) 2009 Monovalent Active immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. 103837/5514 Novartis Vaccines and Diagnostics Limited 9/15/2009

　 Influenza A (H1N1) 2009 Monovalent Active immunization of persons 6 months of age and older against influenza disease caused by pandemic (H1N1) 2009 virus. 103914/5260 Sanofi Pasteur, Inc 9/15/2009

　 Rotarix
Rotavirus Vaccine, Live, Oral, To update the Prescribing Information 125265/126
GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617
5/1/2009

　 Fluarix
Influenza Virus Vaccine To include a thimerosal-free formulation in single-dose prefilled syringes and related changes in the labeling. 125127/314 GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772
License 1617
4/1/2009

　 Infanrix
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Revisions to the package insert to include safety data on the use of INFANRIX following three doses of PEDIARIX and updated safety and immunogenicity data on the concomitant administration of INFANRIX with other recommended vaccines 103647/5196 GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772
License 1617 3/12/2009

　 ORTHO T. cruzi ELISA Test System
Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen Revise the package insert to include adding cadaveric specimens under the Intended Use section and changes to the Specimen Collection and Preparation section by adding Serum Separator Tube (SST) samples, elevated total protein, HAMA, and heterophilic antibodies specimens, as well as the addition of a new 192 test kit configuration. 125161/23 Ortho-Clinical Diagnostics, Inc.
1001 US Highway 202
Raritan , NJ 08869
License 1236 2/18/2009

　 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent To update the Patient Product Information and Prescribing Information. 125122/524 Merck & Co., Inc.
P.O. Box 1000
UG2D-68
North Wales, PA 19454-1099
License 0002 2/5/2009

　 ADACEL
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed To revise the package insert to include revision of the placement of information regarding latex
content of the product. 125111/193 Sanofi Pasteur, Limited
1755 Steeles Avenue West
Toronto , Ontario Canada
License 1726 1/16/2009

●CBER - 2008 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 BioThrax
Anthrax Vaccine Adsorbed Change in schedule and route administration 103821/5080 Emergent BioDefense Operations Lansing, Inc. 3500 N. Martin Luther King, Jr., Blvd.
Lansing , MI 48906
License 1755 12/11/2008

　 Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Booster immunization against diphtheria, tetanus, and pertussis in healthy individuals 19 - 64 years of age 125106/298 Glaxo SmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617 12/4/2008

　 Kogenate FS
Antihemophilic Factor (Recombinant) Routine prophylactic treatment to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage. 103332/5794 Bayer HealthCare LLC
800 Dwight Way, P.O. Box 1986
Berkeley , CA 94701
License 0008 10/10/2008

　 Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant Prevention of vulvar and vaginal cancer 125126/419 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point , PA 19486
License #0002 9/12/2008

　 Gamunex
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse 125046/409 Talecris Biotherapeutics, Inc.
8368 US Hwy 70 West
Clayton , NC 27520
License #1716 9/12/2008

　 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent Includes pertussis immune response data from the Rotavirus Efficacy and Safety Trial (REST) to support concomitant use of DTaP with RotaTeq(R). 125122/368 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point , PA 19486
License 0002 9/5/2008

　 Blood Grouping Reagent: Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing); Anti-Human Globulin (Formulated for Automated Testing) Blood Grouping Reagent, Anti-D (Monoclonal)(IgM) (Formulated for Automated Testing) is used as a component of the Erytype(R) S Rh+K Type plate for Rh typing on the TANGO(R) optimo automated blood grouping and antibody test system. Anti-Human Globulin (Formulated for Automated Testing) is used to detect sensitization of red blood cells on the TANGO(R) optimo system. 125097/10
125098/8 Biotest Medical Diagnostics GmbH
Industriestrasse 1
D-63303 Dreieich
GERMANY
License 1798 8/14/2008

　 Procleix Ultrio Assay
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatits B Virus/Nucleic Acid Pooled Testing/Synthetic) Labeling Changes 125113/19 Gen-Probe Incorporated
10210 Genetic Center Drive
San Diego, CA 92121
License 1592 8/12/2008

　 Pneumovax 23
Pneumococcal Vaccine, Polyvalent Labeling Change: To include the new term "Leukocytosis" in the Adverse Reactions section of the package insert 101094/5245 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 8/6/2008

　 Fluarix
Influenza Virus Vaccine 2008-2009 United States Formulation 125127/294 GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
P.O. Box 61540
King of Prussia, PA 19406-2772
License #1617 8/4/2008

　 Fluvirin
Influenza Virus Vaccine 2008-2009 United States Formulation 103837/5358 Novartis Vaccines and Diagnostics Limited
Gaskill Road
Liverpool L24 9GR
United Kingdom
License #1750 8/1/2008

　 Afluria
Influenza Virus Vaccine 2008-2009 United States Formulation 125254/74 CSL Limited
1020 First Avenue
P.O. Box 60446
King of Prussia, PA 19406-0446
License No. 1764 7/30/2008

　 FluLaval
Influenza Virus Vaccine 2008-2009 United States Formulation 125163/79 ID Biomedical Corporation of Quebec
525 Cartier Blvd, West
Laval, Quebec 87V 3S8 Canada
License 1739 7/28/2008

　 FluMist
Influenza Virus Vaccine Live, Intranasal 2008-2009 United States Formulation 125020/794 MedImmune Vaccines, Inc
297 North Bernardo Avenue
Mountain View CA 94043
License 1652 7/25/2008

　 Fluzone
Influenza Virus Vaccine Revisions to the Package Insert:
To Comply with Physician's Labeling Rule Guidelines 103914/5157 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725 7/14/2008

　 Fluzone
Influenza Virus Vaccine 2008-2009 United States Formulation 103914/5204 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725 7/14/2008

　 FluMist
Influenza Virus Vaccine Live , Intranasal To include labeling revisions for the 2008-2009 influenza season 125020/716 MedImmune Vaccines, Inc
297 North Bernardo Avenue
Mountain View CA 94043
License 1652 7/3/2008

　 GARDASIL
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant To include arthralgia, myalgia, asthenia, fatigue, and malaise in the Adverse Reactions section of the package insert to reflect reports received during post-marketing surveillance, to include corresponding changes to the patient package insert, and to include additional minor editorial changes to the package insert 125126/758 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 6/12/2008

　 TENIVAC
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Use in adults 60 years of age and older for active immunization for the prevention of tetanus and diphtheria 103171/5045 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Canada
License 1726 6/5/2008

　 FluLaval
Influenza Virus Vaccine Update the language in the package insert to be consistent with new content and format labeling requirements 125163/48 ID Biomedical Corporation of Quebec
525 Cartier Blvd, West
Laval, Quebec 87V 3S8 Canada
License 1739 5/16/2008

　 M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live To include epididymitis under Urogenital System in the adverse reactions section of the package insert to reflect reports received during post-marketing surveillance, and to include additional minor editorial changes 101069/5172 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 5/16/2008

　 NovoSevenRT
Coagulation Factor VIIa (Recombinant) Room temperature stable formulation 103665/5231 Novo Nordisk Inc
100 College Rd West
Princeton, NJ 08540
License #1261 5/9/2008

　 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent Include changes to the post-marketing experience section of the label to include a post-marketing report of a death due to intussusception that has occurred after vaccination with RotaTeq 125122/443 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 4/30/2008

　 cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) To include testing for West Nile Virus RNA in post mortem cadaveric (non-heart-beating) donors using an individual testing format 125245/17 Roche Molecular Systems, Inc,
4300 Hacienda Drive
Pleasanton, CA
94588-2722
License 1636 4/2/2008

　 Havrix
Hepatitis A Vaccine, Inactivated To include coadministration of Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM₁₉₇ Protein) (Prevnar(R)) with Hepatitis A Vaccine Inactivated (Havrix(R)) for children in the second year of life 103475/5195 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart, Belgium
License 1617 3/26/2008

　 ADACEL
Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed To include unit dose syringes as an alternate presentation 125111/102 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Canada
License 1726 3/18/2008

　 DAPTACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed To include a fifth dose booster immunization at 4 to 6 years of age following four previous doses of DAPTACEL 103666/5158 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
Canada
License 1726 3/12/2008

　 ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live Revisions to the package insert 125108/266 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 2/27/2008

　 YF-Vax
Yellow Fever Vaccine Changes to the package insert 103915/5086 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725 2/12/2008

　 Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant Changes to the package insert 125126/578 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 1/9/2008

　 EVICEL
Fibrin Sealant (Human) Use in general surgery 125010/105 Omrix biopharmaceuticals Ltd.
200 Chaussee De Waterloo
1640 Rhode-St-Genese
Belgium
License 1603 1/2/2008

●CBER - 2007 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) To include the addition of "crying" to the Adverse Reaction - Postmarketing Experience section of the package insert 103905/5495 Wyeth Pharmaceuticals Inc
401 North Middletown Rd
Pearl River NY 10965
License 0003 12/11/2007

　 M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live Change in the labeled potency of the mumps component from no less than 20,000 TCID₅₀ to no less than 12,500 TCID₅₀ per dose at end of expiry 101069/5061 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 12/6/2007

　 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent Changes to the package insert 125122/314 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 11/28/2007

　 Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Changes to the package insert 103905/5470 Wyeth Pharmaceuticals Inc
401 North Middletown Rd
Pearl River NY 10965
License 0003 11/13/2007

　 Fluvirin
Influenza Virus Vaccine Update package insert 103837/5108 Novartis Vaccines and Diagnostics Limited
Gaskill Road, Speke
Liverpool L24 9GR
United Kingdom
License 1750 11/9/2007

　 ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live Package insert revisions 125108/218 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 10/23/2007

　 Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human) To include a change in the storage conditions (up to 25ﾂｺC) for the complete shelf life of 24 months 103960/5346 CSL Behring GmbH
1020 First Avenue
King of Prussia, PA 19406-0901
Licence 1765 10/19/2007

　 Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W-135) Diphtheria Toxoid Conjugate Vaccine Expanded age indication for subjects 2-10 years of age 125089/2 Sanofi Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1725 10/18/2007

　 Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type Labeling Supplement:
Include additional language regarding skin lesions at the smallpox vaccination site 101106/5089 Wyeth Pharmaceuticals, Inc
401 North Middletown Rd
Pearl River NY 10965
License 0003 10/2/2007

　 Gardasil
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Changes to the package insert 125126/428 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 10/1/2007

　 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent Revised Labeling:
Include the addition of G9 P1A[8] Serotype case reduction in the "Clinical Studies" section of the package insert, and revisions of the label in the Physician's Labeling Rule format 125122/201 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 9/28/2007

　 M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live Changes to the package insert 101069/5143 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 9/24/2007

　 FluMist
Influenza Virus Vaccine Live, Intranasal Indication Revision:
For the active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine 125020/322 MedImmune Vaccines, Inc
(a wholly owned subsidiary of MedImmune, Inc.)
297 North Bernardo Ave
Mountain View, CA 94043
License 1652 9/19/2007

　 FluLaval
Influenza Virus Vaccine New Formulation:
2007-2008 United States formulation 125163/39 ID Biomedical Corporation of Quebec
525 Cartier Blvd, West
Laval, Quebec 87V 3S8 Canada
License 1739 9/12/2007

　 COBAS AmpliScreen HBV Test
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) Changes in the labeling, testing requirement, and an increase in reagent refrigerator cycles 125090/21 Roche Molecular Systems, Inc
4300 Hacienda Drive
P.O. Box 9002 Pleasanton, CA 94566-0990
License 1636 8/16/2007

　 Fluarix
Influenza Virus Vaccine New Formulation:
2007-2008 United States formulation 125127/229 GlaxoSmithKline Biologicals
2301 Renaissance Boulevard
Building 510, P.O. Box 61540
King of Prussia, PA 19406-2772
License 1617 7/24/2007

　 Fluvirin
Influenza Virus Vaccine New Formulation:
2007-2008 United States formulation 103837/5240 Novartis Vaccines and Diagnostics Limited
Gaskill Road, Speke
Liverpool L24 9GR
United Kingdom
License 1750 7/24/2007

　 Fluzone
Influenza Virus Vaccine New Formulation:
2007-2008 United States formulation 103914/5167 Sanofi Pasteur, Inc.
Discovery Drive
Swiftwater, PA 18370 License 1725 7/13/2007

　 Zostavax
Zoster Vaccine Live To include a statement in the package insert regarding concomitant administration of ZOSTAVAX with inactivated influenza vaccine 125123/90 Merck & Co., Inc.
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 7/6/2007

　 Carticel
Autologous Cultured Chondrocytes Revised Package Insert:
To include safety and efficacy data from the Study of the Treatment of Articular Repair; and formatting and content changes in compliance with the Physician's Labeling Rule 103661/5155 Genzyme Biosurgery
55 Cambridge Parkway
Cambridge, MA 02142
License 1659 6/21/2007

　 Procleix Ultrio Assay
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus and/or Hepatitis B Virus (HIV-1 and Hepatitis C Virus and Hepatits B Virus/Nucleic Acid Pooled Testing/Synthetic) To add the Procleix TIGRIS System for use with the Procleix Ultrio Assay 125113/2 Gen-Probe Inc
10210 Genetic Center Dr
San Diego, CA 92121
License 1592 5/23/2007

　 COBAS AmpliScreen HIV-1 Test, version 1.5
Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction) Changes in labeling, testing requirement, and increase in reagent refrigerator cycles 125059/37 Roche Molecular Systems, Inc
4300 Hacienda Drive
P.O. Box 9002
Pleasanton CA 94566-0990
License 1636 5/23/2007

　 COBAS AmpliScreen HCV Test
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) Changes in labeling, testing requirement, and increase in reagent refrigerator cycles 125045/5034 Roche Molecular Systems, Inc
4300 Hacienda Drive
P.O. Box 9002
Pleasanton CA 94566-0990
License 1636 5/22/2007

　 RECOMBIVAX HB
Hepatitis B Vaccine (Recombinant) Changes to the package insert 101066/5159 Merck & Co., Inc.
P.O. Box 4
West Point, PA 19486-0004
License 0002 5/15/2007

　 EVICEL
Fibrin Sealant (Human) An adjunct to hemostasis for use in patients undergoing liver or vascular surgery when control of bleeding by standard surgical techniques is ineffective or impractical 125010/74 Omrix biopharmaceuticals Ltd.
113 SE 5th Street
Oak Island, NC 28465
License 1603 5/9/2007

　 VAQTA
Hepatitis A Vaccine, Inactivated Changes to the package insert 103606/5209 Merck & Co., Inc
P.O. Box 4
West Point, PA 19486-0004
License 0002 5/8/2007

　 ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live Changes to the package insert 125108/170 Merck & Co., Inc
P.O. Box 4
West Point, PA 19486-0004
License 0002 5/8/2007

　 Aralast NP
Alpha-1-Proteinase Inhibitor (Human) For further manufacture into Alpha-1-Proteinase Inhibitor (A1PI) 125039/263 Baxter Healthcare Corp
One Baxter Way
Westlake Village, California 91362
License 0140 5/4/2007

　 Humate-P
Antihemophilic Factor/von Willebrand Factor Complex (Human) Additional Indication: For adult and pediatric patients with von Willebrand disease for the prevention of excessive bleeding pre and post surgery 103960/5243 CSL Behring GmbH.
1020 First Avenue
King of Prussia, PA 19406
License 1765 4/27/2007

　 GARDASIL
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Changes to the package insert 125126/159 Merck & Co., Inc.
P.O. Box 4
West Point, PA 19486-0004
License 0002 4/3/2007

　 Menactra
Meningococcal Groups (A, C, Y and W135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine To include a single dose syringe presentation 125089/3 Sanofi Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370
License 1725 3/30/2007

　 TWINRIX
Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine Revised Package Insert: For an accelerated dosing schedule of 0, 7, 21-30 days and a month 12 booster dose 103850/5162 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617 3/28/2007

　 Rhophylac
Rho(D) Immune Globulin Intravenous (Human) Expanded indication: for the treatment of Rho(D) positive, non-splenectomized adult patients with chronic Immune Thrombocytopenia Purpura (ITP) 125070/149 ZLB Behring AG
1020 First Avenue
King of Prussia, PA 19406-0901
License 1710 3/26/2007

　 Pediarix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Labeling Changes 103907/5195 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617 3/16/2007

　 Procleix West Nile Virus (WNV) Assay
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) Revised Labeling:
To perform the Procleix WNV Assay with the Procleix TIGRIS System 125121/17 Gen-Probe Inc
10210 Genetic Center Dr
San Diego, CA 92121
License 1592 3/2/2007

　 ProQuad
Measles, Mumps, Rubella and Varicella Virus Vaccine Live Revised Package Insert 125108/164 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA. 19486
License 0002 2/27/2007

　 RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent Changes to the Package Insert: Including cases of intussusception and hematochezia seen post-marketing 125122/219 Merck & Co., Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 2/12/2007

　 Alphanate
Antihemophilic Factor (Human) For surgical and/or invasive procedures in patients with von Willebrand Disease (VWD) in whom desmopressin (DDAVP) is either ineffective or contraindicated. It is not indicated for patients with severe VWD (Type 3) undergoing major surgery. 102475/5002 Grifols Biologicals Inc
5555 Valley Boulevard
Los Angeles, CA 90032
License 1694 1/31/2007

　 MERUVAX II
Rubella Virus Vaccine Live Revised Package Insert 101075/5074 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002 1/31/2007

　 ATTENUVAX
Measles Virus Vaccine Live Revised Package Insert 101068/5080 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002 1/31/2007

　 Engerix-B
Hepatitis B Vaccine (Recombinant) Thimerosal-free formulation 103239/5109 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617 1/30/2007

　 GARDASIL
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Revised Package Insert 125126/109 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002 1/30/2007

　 Pediarix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Revised Package Insert:
For a preservative free/thimerosal free formulation 103907/5148 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617 1/29/2007

　 TWINRIX
Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine Revised Package Insert 103850/5173 GlaxoSmithKline Biologicals
Rue de I'Institut 89
B1330 Rixensart
Belgium
License 1617 1/19/2007

　 Tubersol
Tuberculin, Purified Protein Derivative Revised Package Insert 103941/5044 Sanofi Pasteur Limited
1755 Steeles Avenue West
Toronto, Ontario M2R 3T4
CANADA
License 1726 1/8/2007

　 FluMist
Influenza Virus Vaccine Live, Intranasal New Formulation:
Convert from the frozen formulation to a liquid formulation 125020/90 MedImmune Vaccines, Inc
(a wholly owned subsidiary of MedImmune, Inc.)
297 North Bernardo Ave
Mountain View, CA 94043
License 1652 1/5/2007

●CBER - 2006 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 M-M-R II
Measles, Mumps, and Rubella Virus Vaccine, Live Changes to the package insert 101069/5116 Merck & Co., Inc
P.O. Box 1000
North Wales, PA 19454-1099
License 0002 12/29/2006
　 Flebogamma 5% DIF
Immune Globulin Intravenous (Human) Addition of a viral inactivation step, new manufacturing facility, and a 400mL fill size 125077/47 Instituto Grifols, S.A.
2 Can Guasch St
Poligono Levante
Parets del Valles
Barcelona, Spain 08150
License 1181 12/21/2006
　 Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Changes to the package insert 103905/5332 Wyeth Pharmaceuticals Inc.
401 North Middleton Rd
Pearl River , New York 10965
License 0003 11/22/2006
　 HibTITER
Haemophilus b Conjugate Vaccine (Diphtheria CRM197 Protein Conjugate) Changes to the package insert 103578/5063 Wyeth Pharmaceuticals Inc
401 North Middletown Rd
Pearl River, NY 10965
License 0003 11/17/2006
　 Varivax
Varicella Virus Vaccine Live Revised Package Insert 103552 / 5141 Merck & Co., Inc.
P.O. Box 1000, UG2D-68
North Wales, PA 19454-1099
License 0002 11/9/2006
　 DAPTACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Revised labeling 103666/5071 Sanofi Pasteur Ltd
1755 Steeles Avenue West
Toronto, Ontario
M2R 3T4 Canada
License 1726 11/8/2006
　 NovoSeven
Coagulation Factor VIIa (Recombinant) Treatment of bleeding episodes and for the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia 103665/5119 Novo Nordisk A/S
Novo Nordisk Pharmaceuticals, Inc.
100 College Rd West
Princeton, NJ 08540
License 1261 10/13/2006

　 APTIMA HIV-1 RNA Qualitative Assay
Human Immunodeficiency Virus Type 1 and Hepatitis C Virus (HIV-1 and HCV/Nucleic Acid Pooled Testing/Synthetic) Qualitative detection of human immunodeficiency virus type 1 (HIV-1) in human plasma. It is intended for use as an aid in diagnosis of HIV-1 infection, including acute or primary infection. 103966 / 5040 Gen-Probe Inc
10210 Genetic Center Dr
San Diego, CA 92121
License 1592 10/4/2006

　 Menactra
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Revised Package Insert 125089 / 104 Sanofi Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1725 10/3/2006

　 Daptacel
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Manufacture of the Pertussis antigen component 103666 / 5069 Sanofi Pasteur, Ltd.
1755 Steeles Ave West
Toronto, Ontario Canada M2R3T4 8/23/2006

　 Tisseel VH Kit
Fibrin Sealant (Tisseel) To include the incorporation of a second, independent virus inactivation step (solvent/detergent treatment), modifications to the manufacturing process and manufacturing locations within the Vienna facilities and the introduction of a frozen liquid presentation of the product 103980 / 5121 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362 7/27/2006

　 Fluarix
Influenza Virus Vaccine New Formulation:
2006-2007 United States formulation 125127 / 139 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617 7/25/2006

　 Fluvirin
Influenza Virus Vaccine Labeling revisions and 2006-2007 United States formulation 103837 / 5104 Chiron Vaccines Ltd
Gaskill Road Speke,
Liverpool, L24 9GR, UK
License 1720 7/21/2006

　 FluMist
Influenza Virus Vaccine Live, Intranasal New Formulation:
2006-2007 United States formulation 125020 / 238 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652 7/21/2006

1244 Varivax
Varicella Virus Vaccine Live Revised Package Insert 103552 / 5124 Merck & Co., Inc
Sumneytown Pike
P.O. Box 4, BLB-22
West Point, PA 19486 7/12/2006

　 Fluzone
Influenza Virus Vaccine Labeling revisions for the 2006-2007 influenza season 103914 / 5125 Sanofi Pasteur, Inc.
Discovery Drive
Swiftwater, PA 18370
License 1725 7/10/2006

　 FluMist
Influenza Virus Vaccine Live, Intranasal Labeling revisions for the 2006-2007 influenza season 125020 / 201 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652 6/15/2006

　 Pediarix
DTaP & Hepatitis B (Recombinant) & Inactivated Polio Virus Vaccine Revised package insert for a safety and immunogenicty of a three dose series of Pediarix when administered with other recommended US-licensed vaccines including Prevnar 103907 / 5034 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617 4/4/2006

　 Havrix
Hepatitis A Vaccine Inactivated Package insert labeling changes regarding geriatric use 103475/5100 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617 2/21/2006

　 OCTAGAM
Immune Globulin Intravenous, Human 5% Revised Package Insert
Include labeling changes to the "Warnings/Blood Glucose Testing" and "Precautions/Drug/Laboratory Test Interactions" sections of the package insert strengthening the warning of effects of maltose in the product 125062 / 57 OCTAPHARMA Pharmazeutika Produktionsges.m.b.H
Oberlaaer Strasse 235
A-1100
Vienna Austria
License 1646 2/3/2006

　 Adacel
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Revised Package Insert 125111 / 2 Sanofi Pasteur Limited
1755 Steeles Ave West
Toronto, Ontario M2R 3T4
Canada
License 1726 1/23/2006

　
　　　　

●CBER - 2005 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Boostrix
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Package Insert Revision:
Include addition of clinical safety information to the package insert 125106 / 10 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart
Belgium
License 1617 12/29/2005

　 Menactra
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Package Insert Revision 125089 / 47 Aventis Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 10/21/2005

　 Havrix
Hepatitis A Vaccine, Inactivated Package Insert Revision:
To support lowering the age indication for Havrix from two years to 12 months of age 103475 / 5090 GlaxoSmithKline Biologicals
Rue de l'Institut 89
B1330 Rixensart Belgium
License 1617 10/17/2005

　 Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type Package Insert Revision:
Include a new Black Box warning for cardiac events and other safety information 101106 / 5067 Wyeth Pharmaceuticals, Inc
401 North Middleton Road
Pearl River, NY 10965-8668
License 0003 10/11/2005

　 Tetanus Toxoid Adsorbed New Dosage Form:
Addition of a preservative free single dose vial formulation 103913 / 5047 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 9/23/2005

　 Fluvirin
Influenza Virus Vaccine New Formulation:
2005-2006 United States formulation 103837 / 5066 Chiron Vaccines Ltd
Gaskill Road
L249GR
Speke, Liverpool UK
License 1720 9/14/2005

　 Aralast
Alpha-1-Proteinase Inhibitor (Human) Manufacturing Change:
---- Fr.IV₁₊₄ paste as an alternate starting material 125039 / 69 Baxter Healthcare Corp
One Baxter Way
Westlake Village, CA 91362
License 0140 9/9/2005

　 FluMist
Influenza Virus Vaccine Live, Intranasal New Formulation:
2005-2006 United States formulation 125020 / 69 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652 8/18/2005

　 NovoSeven
Coagulation Factor VIIa (Recombinant) Expanded Indication for Use:
For use in surgical procedures in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX 103665 / 5057 Novo Nordisk Pharmaceuticals, Inc
100 College Road West
Princeton, NJ 08540
License 1261 8/12/2005

　 VAQTA
Hepatitis A Vaccine, Inactivated Expanded Indication for Use:
Lowering the age indication for VAQTA from two years to 12 months of age 103606 / 5049 Merck & Co, Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486
License 0002 8/11/2005

　 COBAS AmpliScreen HBV Test
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) Expanded Indication for Use:
Testing for Hepatitis B Virus DNA in post-mortem cadaveric (non-heart-beating) donors using an individual testing format 125090 / 3 Roche Molecular Systems, Inc
4300 Hacienda Drive
Pleasanton, California 94566-0900
License 1636 8/2/2005

　 Reagent Red Blood Cells Manufacturing Change:
Include modification to the manufacturing process and creation of new Reverse-Cyte A₁ and B cells and Search-Cyte Pool, Duo and Trio Reagent Red Blood Cell products for use on the TANGO Automated Blood Bank Analyzer 103898 / 5019 Medion Diagnostics GmbH
Bonnstrasse 9
CH-3186 Dudingen
Switzerland
License 1616 7/26/2005

　 Fluzone
Influenza Virus Vaccine New Formulation:
Include a preservative free single dose presentation in a unit dose vial 103914 / 5097 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 7/14/2005

　 Fluzone
Influenza Virus Vaccine New Formulation
Include the 2005-2006 United States formulation 103914 / 5101 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 7/14/2005

　 NovoSeven
Coagulation Factor VIIa (Recombinant) New Indication for Use:
Treatment of bleeding episodes in patients with Factor VII Deficiency 103665 / 5052 Novo Nordisk Pharmaceuticals, Inc
100 College Road West
Princeton, NJ 08540
License 1261 7/11/2005

　 Diphtheria and Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use) For further manufacture to Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with GlaxoSmithKline Biologicals 103648 / 5046 Chiron Behring GmbH & Co
P.O. Box 1630
35006 Marburg
Germany
License 1222 5/3/2005

　 Biothrax
Anthrax Vaccine Adsorbed Extension of dating to 36 months 103821 / 5070 BioPort Corp
3500 N. Martin Luther King, Jr. Blvd
Lansing, MI 48906
License 1260 4/27/2005

1244 Varivax
Varicella Virus Vaccine Live Optional second dose for children 12 months to 12 years of age 103552 / 5079 Merck & Co, Inc
Sumneytown Pike
P.O. Box 4
West Point, PA 19486
License 0002 4/5/2005

　 WinRho SDF Liquid
Rho(D) Immune Globulin Intravenous (Human) New Formulation:
Provide for a liquid formulation 103649 / 5107 Cangene Corp
104 Chancellor Matheson Rd
Winnepeg, Manitoba
Canada R3T5Y3
License 1201 3/31/2005

　 FluMist
Influenza Virus Vaccine Live, Intranasal Package Insert Revision
Changes to the previously approved 2004-2005 US labeling (package insert) 125020 / 44 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA
License 1652 3/18/2005

　 COBAS AmpliScreen HCV Test, version 2.0
Hepatitis C Virus (Hepatitis C Virus / Polymerase Chain Reaction / Blood Cell Derived) Expanded Indication for Use:
Testing of individual cadaveric specimens (obtained from non-heart-beating donors) 125045 / 5015 Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900
License 1636 3/9/2005

　 COBAS AmpliScreen HIV-1 Test, version 1.5
Human Immunodeficiency Virus Type 1 (HIV-1 / Polymerase Chain Reaction) Expanded Indication for Use
Testing of individual cadaveric specimens (obtained from non-heart-beating donors) 125059 / 13 Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900
License 1636 3/9/2005

●CBER - 2004 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Fluzone
Influenza Virus Vaccine New Dosage Form:
Single dose formulation without thimerosal for the 0.25 mL and 0.5 mL syringes 103914 / 5082 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 12/23/2004

　 Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type Package Insert Revision:
Include a Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults 101106 / 5057 Wyeth Pharmaceuticals, Inc
401 N. Middletown Rd
Pearl River, NY 10965
License 0003 11/5/2004

　 FluMist
Influenza Virus Vaccine Live, Intranasal New Storage Conditions:
Storage of FluMist vaccine for the current 2004-2005 influenza vaccination season in a conventional frost-free freezer without a "FreezeBox" 125020 / 43 MedImmune Vaccines, Inc
One MedImmune Way
Gaithersburg, MD 20878
License 1652 11/2/2004

　 FluMist
Influenza Virus Vaccine Live, Intranasal New formulation:
2004-2005 United States Formulation 125020 / 33 MedImmune Vaccines, Inc
297 N. Bernardo Ave
Mountain View, CA 94043
License 1652 9/15/2004

　 HIVAB HIV-1 / HIV-2 (rDNA) EIA
Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA)/Recombinant) Labeling Change:
Include cadaveric serum specimen testing 103385 / 5004 Abbott Laboratories
D-049C/AP6C/2
100 Abbott Park Road
Abbott Park, IL 60064-3500
License 0043 7/22/2004

　 Abbott HCV EIA 2.0
Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant) Labeling Change:
Include cadaveric serum specimen testing 103356 / 5000 Abbott Laboratories
D-049C/AP6C/2
100 Abbott Park Road
Abbott Park, IL 60064-3500
License 0043 7/22/2004

　 Fluzone
Influenza Virus Vaccine New formulation:
2004-2005 United States Formulation 103914 / 5077 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 7/2/2004

　 FluVirin
Influenza Virus Vaccine New formulation:
2004-2005 United States Formulation 103837 / 5053 Evans Vaccines, Ltd
Gaskill Road
Speke, Liverpool L24 9GR
United Kingdom
License 1615 7/2/2004

　 Procleix
Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic) Expanded indication for use:
Testing for Source Plasma donors in a mini-pool format of up to 16 donations with single unit resolution testing; and testing individual plasma specimens from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) and for testing individual cadaveric specimens (obtained from non-heart-beating donors) 103966 / 5021 Gen-Probe, Inc
10210 Genetic Center Drive
San Diego, California 92121-1589
License 1592 6/4/2004

　 COBAS Ampliscreen HCV
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) Expanded indication for use:
Testing for Source Plasma donors in a mini-pool format of up to 96 donations with single unit resolution testing; and testing individual plasma samples from other living donors and organ donors (when specimens are obtained while the donor's heart is still beating) 125045 / 5011 Roche Molecular Systems
4300 Hacienda Drive
PO Box 9002
Pleasanton, CA 94566-0900
License 1636 5/13/2004

　 Biothrax
Anthrax Vaccine Adsorbed Extension of dating to 24 months 103821 / 5051 BioPort Corp
3500 N. Martin Luther King Jr Blvd
Lansing, MI 48906
License 1260 4/29/2004

　 DECAVAC
Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use New Dosage Form:
Addition of a preservative-free, single dose Luer-Lok syringe presentation 103921 / 5031 Aventis Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1277 3/24/2004

　 Carticel
Autologous Cultured Chondrocytes Processing Change:
To utilize the BacT/Alert automated microbial detection system for the release of Carticel product based on interim negative results at approximately day 3 of a 14-day assay 103661 / 5019 Genzyme Biosurgery
55 Cambridge Parkway
Cambridge, MA 02142
License 1659 2/17/2004

●CBER - 2003 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Diphtheria and Tetanus Toxoids Adsorbed (DT), for Pediatric Use Indication for Use:
To include addition of a preservative-free, single dose vial presentation 103919 / 5018 Aventis Pasteur, Inc
Discovery Drive
Swiftwater, PA 18370
License 1277 1/29/2003

　 Infanrix
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Indication for Use:
To include in the indication a fifth dose at 4-6 years of age after 4 prior doses of Infanrix 103647 / 5001 GlaxoSmithKline Biologicals
89, Rue de l’Institut
1330 Rixensart
Belgium
License 1090 7/7/2003

　 Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type Package Insert Revision:
Include new safety information for the recent reports of cardiac events and updated storage period for the vaccine after reconstitution from 15 days to 90 days 101106 / 5030 Wyeth Laboratories, Inc.
Wasp & Biddle Streets, P.O. Box 304, Marietta, PA 17547
License 0003 6/26/2003

　

　　　

●CBER - 2002 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Biothrax
Anthrax Vaccine Adsorbed Manufacturing Change:
Hollister-Stier as contract manufacturer for filling 103821
/5020 BioPort Corp
3500 N. Martin Luther King Jr. Blvd
Lansing, MI 48906
License 1260 1/31/2002
　 Biothrax
Anthrax Vaccine Adsorbed Labeling Change:
Updated product labeling 103821
/5015 BioPort Corp
3500 N. Martin Luther King Jr. Blvd
Lansing, MI 48906
License 1260 1/31/2002

　 none
Blood Grouping Reagent Combination Kit Indication for Use:: Manufacture of a "Monoclonal Rh Phenotype Card" 103756
/5001 Micro Typing Systems, Inc
1295 S.W. 29th Avenue
Pompano Beach, FL 33069
License 1177 5/14/2002

　 Fluzone
Influenza Virus Vaccine Indication for use: Preservative free formulation in a single dose presentation in 0.25 ml syringes for pediatric use and 0.5 ml syringes for adults and children 103914
/5030 Aventis Pasteur Inc
Discovery Drive
Swiftwater, PA 18370-0187
License 1277 9/4/2002

　 VAQTA
Hepatitis A Vaccine Inactivated New Dosing Schedule: Extension of the timing of the booster dose in adults from 6 to 18 months 103606
/5003 Merck & Co, Inc
P.O. Box 4
Sumneytown Pike
West Point, PA 19486-0004
License 0002 9/4/2002

1153 Prevnar
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein Indication for Use:Immunization of infants and toddlers against otitis media caused by vaccine serotypes 103905/1003 Lederle Laboratories Division
401 N. Middletown Road
License 0017 10/1/2002

1147 Dryvax
Smallpox Vaccine, Dried, Calf Lymph Type Indication for Use:
Active immunization against smallpox disease 101106/5015 Wyeth Laboratories, Inc
P.O. Box 304
Wasp & Bittle Streets
Marietta, PA 17547
License 0003 10/25/2002

●CBER - 2001 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Tripedia
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed New Formulation:
A preservative-free, single dose vial presentation(reduced thimerosal) 103922
/5001 Aventis Pasteur Inc.
Discovery Drive
Swiftwater, PA 18370
License 1277 3/7/2001

●CBER - 2000 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Genetic Systems HIV-1 / HIV-2 Peptide EIA
Human Immunodeficiency Virus Type 1 and 2 (Synthetic Peptide) Expanded Indication:
Testing of cadaveric serum samples Genetic Systems Corporation
6565 185th Avenue NE
Redmond, WA 98052-5039
License 0978 2/09/2000

　 Carticel SM Service
Autologous Cultured Chondrocytes Narrow the indication to second line therapy, for use in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure Genzyme Tissue Repair
64 Sidney Street
Cambridge, MA 02139-4136
License 1233 3/2/2000

　 Kogenate FS
Antihemophilic Factor (Recombinant) New product formulation Bayer Corporation
800 Dwight Way
P.O.Box 1986
Berkeley, CA
License 0008 6/26/2000

　 Anti-D, Anti-A, Anti-B, Anti-A,B Monoclonal Antibodies First approval for monoclonal antibodies to be used in a gel card; for further manufacture in a shared agreement with Micro Typing Systems, Inc. 103856
/1001 Serologicals LTD
Fleming Road
Livingston, United Kingdom
License 1270 9/21/2000

　 ID Micro Typing Systems
A/B/D Monoclonal Grouping Combination Gel Card First approval for production of a monoclonal grouping combination gel card 103756
/1005 Micro Typing Systems, Inc.
1295 S.W. 29th Avenue
Pompano Beach, Fl
License 1177 9/27/2000

●CBER - 1999 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Immune Globulin Intravenous (Human) New Indication:
For treatment of Kawasaki Disease in conjunction with high dose aspirin (80-100 mg/kg/day in four divided doses) Baxter Healthcare Corporation
550 North Brand Boulevard
Glendale, CA 91203
License 0140 01/07/1999

　 Chiron RIBA HCV 3.0 SIA
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic) (RIBA) New Indication:
An improved, more specific, supplemental test to confirm screening test results for antibodies to Hepatitis C Virus in human serum or plasma Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
License 1106 02/11/1999

　 Recombivax
Hepatitis B Vaccine Manufacturing Change:
Preservative-free pediatric / adolescent product Merck & Co., Inc.
P.O. Box 4
Summneytown Pike
West Point, PA 19486
License 0002 08/27/1999

　 Recombivax
Hepatitis B Vaccine Labeling Change:
Addition of two doses of the 10 mcg formulation (1.0 mL) administered at 0 and 4 to 6 months as an alternate regimen for the routine vaccination of healthy adolescents 11 to 15 years of age Merck & Co., Inc.
P.O. Box 4
Summneytown Pike
West Point, PA 19486
License 0002 09/23/1999

　 TheraCys
BCG Live New Indication:
Prophylaxis of primary and recurrent Ta and/or T1 papillary tumors following transurethral resection (TURB) Connaught Laboratories Limited
1755 Steeles Avenue, West
North York, Ontario, M2R 3T4
CANADA
License 0073 11/08/1999

　 Genetic Systems HbsAg Confirmatory Assay 2.0
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) Improved Test:
Allows for testing of blood from an already deceased potential transplant donor Genetic Systems Corporation
6565 185th Avenue NE
Redmond, WA 98052-5039
License 0978 12/28/1999

●CBER - 1998 Biological License Application Supplement Approvals

ML Tradename/
Proper Name
Indication for Use Manufacturer/
License No.
Approval Date

　 Cambridge Biotech HIV-1 (Western Blot)
Human Immunodeficiency Virus Type 1 (Western Blot) New Indication:
For urine specimen testing Cambridge Biotech Corp.
1500 E. Gude Drive
Rockville, MD 20850
License 1063
05/28/1998

　 Genetic Systems rLAV
Human Immunodeficiency Virus Type 1 New HIV-1 enzyme immunoassay (EIA) which contains a combination of HIV-1 viral lysate and HIV-1 recombinant antigen Genetic Systems Corporation
6565 185th Avenue, NE
Redmond, WA 98052-5039
License 0978 06/29/1998

　 Engerix-B
Hepatitis B Vaccine (Recombinant) New/Expanded Indication:
For use in individuals (adults) with chronic Hepatitis C infection SmithKline Beecham Biologicals
Rue de l'Institut 89
B-1330 Rixensart
BELGIUM
License 1090 07/07/1998

　 TICE BCG
BCG Live Expanded Indication:
For intravesical instillation to include adjunct treatment of stage Ta or T1 papillary tumors of the bladder Organon Teknika Corporation
100 Akzo Avenue
Durham, NC 27712
License 0956 08/21/1998

　 Mycobax
BCG Vaccine Expanded Indication:
For immunization against tuberculosis Connaught Laboratories Limited
1755 Steeles Avenue, West
North York, Ontario
Canada MR2 3T4
License 0073 10/09/1998

　 Genetic Systems HIV-1 Western Blot
Human Immunodeficiency Virus Type 1 (Western Blot) New Indication:
New HIV-1 Western Blot assay intended for use with persons of unknown risk as more specific test on human serum, plasma, or dried blood specimens found to be repeatedly reactive using screening procedure Genetic Systems Corporation
6565 185th Avenue NE
Redmond, WA 98052-5039
License 0978 11/23/1998

　 Cytomegalovirus Immune Globulin Intravenous (Human) New Indication:
Prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver pancreas and heart Massachusetts Public Health
Biologic Laboratories
305 South Street
Boston, MA 02130-3597
License 0064 12/04/1998

●CBER - 1997 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Venoglobulin-I or
Venoglobulin-S
Immune Globulin Intravenous (Human) New Indication:
Treatment of Kawasaki Disease in conjunction with high dose aspirin
(100 mg/kg/day) Alpha Therapeutic Corporation
5555 Valley Blvd.
Los Angeles, CA 90032
License 0744 01/10/1997

　 Havrix
Hepatitis A Vaccine Inactivated New Indication:
Prevention of Hepatitis A in patients with chronic liver disease SmithKline Beecham
89, rue de l'Institut
1330 Rixensart
BELGIUM
License 1090 06/25/1997

FDA-CDER-Biologics●Approval Information

■FDA-CDER Biological Therapeutic Products -http://www.fda.gov/cder/biologics/
Approval Information(Labels and Reviews) - ★承認医薬品リスト

Therapeutic Biological Approvals [最終更新2003.12.12]
　最近分は、Drugs@FDA

ML	Tradename/ Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
	Abbokinase Urokinase	For adults for the lysis of acute massive pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments, and for the lysis of pulmonary emboli accompanied by unstable hemodynamics, i.e., failure to maintain blood pressure without supportive measures	76-1021 / 076	Abbott Laboratories 200 Abbott Park Road Dept 037N, j45-2 Abbott Park, IL 60064-6133	10/10/2002
	*ACTIMMUNE* Interferon gamma-1b	New Indication: Delaying the time to disease progression in patients with severe, malignant osteopetrosis		InterMune Pharmaceuticals, Inc. 3294 West Bayshore Road Palo Alto, CA 94303 License 1267	2/10/2000
	Activase Alteplase			Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/18/1996
	Activase Alteplase	Labeling Change: Addition of information regarding orolingual angioedema to the Precautions and Adverse Reactions sections, and bolding a statement in the Dosage and Administration section	103172 / 5009	Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 License 1048	5/15/2002
1168	*Aldurazyme* Laronidase	For patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. Laronidase has been shown to improve pulmonary function and walking capacity. Laronidase has not been evaluated for effects on the central nervous system manifestations of the disorder	125058 / 0	Biomarin Pharmaceutical Inc 371 Bel Marin Keys Boulevard Suite 210 Novato, CA 94949 License 1649	4/30/2003
1145	*Amevive* Alefacept※日x	(乾癬)Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy	125036 / 0	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	1/30/2003
1120	Aranesp Darbepoetin alfa	Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis	103951/0	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1789 License 1080	9/17/2001
	Aranesp Darbepoetin alfa	New Indication: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy	103951 / 5001	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA License 1080	7/19/2002
1184	Avastin (bevacizumab) Package Insert※[日]発売	(大腸癌)First-line treatment for patients with metastatic colorectal cancer	125085/0	Genentech, Inc. -1 DNA Way MS#48, South San Francisco, CA 95080; Lincense 1048	2/26/2004
	*AVONEX* Interferon beta-1a	Treatment of multiple sclerosis (orphan indication)		Biogen, Inc. 14 Cambridge Center Cambridge, MA 02142 License 1204	05/17/1996
	Avonex Interferon beta-1a	Revised Package Insert: To include safety and efficacy data from a study of patients who experienced a single clinical exacerbation of multiple sclerosis and to provide a Medication Guide	103628 / 5001	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	1/31/2003
	Avonex Interferon beta-1a	Indication for Use: To include an HSA-free liquid formulation in a prefilled syringe as an alternate dosage form	103628 / 5021	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	5/28/2003
1141	AVONEX Interferon beta-1a	Revised Package Insert: Updated information regarding serum neutralizing antibodies	103628 / 5008	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	11/12/2002
1031	Becaplermin Concentrate	For further manufacture under a shared manufacturing arrangement with OMJ Pharmaceuticals, Inc.		Chiron Corporation 4560 Horton Street Emeryville, CA 94608 License 1106	12/16/1997
	Betaseron Interferon beta-1b	Revised Package Insert: Revised the Clinical Studies section (include data from two studies conducted in patients with secondary progressive multiple sclerosis (MS)), Adverse Reactions and Warnings sections (include new safety information); and provided a Medication Guide	103471 / 1039	Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 License 1106	3/14/2003
	Betaseron Interferon beta-1b Letter Label	Provides for the use of diluent in a prefilled syringe, instead of a vial configuration.	103471 / 5032	Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 License 1106	10/10/2003
1168	*Bexxar* Tositumomab and Iodine I-131 Tositumomab※[日]未	(非ホジキンリンパ腫)Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy	125011 / 0	(現GSK)Corixa Corp 1124 Columbia Street Suite 200 Seattle, WA 98104 License 1614	6/27/2003
1131	BOTOX COSMETIC Botulinum Toxin Type A	New Indication: Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 65 years of age	103000 / 5000	Allergan, Inc 2525 Dupont Drive P.O. Box 195 Irvine, CA 92713-9534 License 1145	4/12/2002
	*BOTOX* Botulinum Toxin Type A	New Indication: Treatment of cervical dystonia	103000/1004	Allergan, Inc. 2525 Dupont Drive P.O. Box 195 Irvine, CA 92713-9534 License 1145	12/21/2000
	Campath Alemtuzumab※[日]未	(Ｂ細胞慢性リンパ球白血病)Treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy	103948/0	Millennium and ILEX Partners, LP 75 Sidney Street Cambridge, MA 02139 License 1289	5/7/2001
	Cathflo Activase Alteplase	New Indication: Restoration of function to central venous access devices (as assessed by the ability to withdraw blood)	103172 / 5003	Genentech Inc 1 DNA Way South San Francisco, CA 94080 License 1048	9/4/2001
	*CEA-Scan* Arcitumomab※[日]未	(大腸癌検出用造影剤)Imaging agent used in the detection of colorectal carcinoma		Immunomedics, Inc. 300 American Road Morris Plains, NJ 07950 License 1205	06/28/1996
1143	*Elitek* Rasburicase	Initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid	103946 / 0	Sanofi-Synthelabo, Inc 9 Great Valley Parkway P.O. Box 3026 Malvern, PA 19355 License 1294	7/12/2002
	Elspar Asparaginase	Revised Package Insert: Add Geriatric Use subsection in the Precautions section	101063 / 5012	Merck and Co, Inc Sumneytown Pike P.O. Box 4 UN-B121 West Point, PA 19486-0004 License 0002	8/1/2002
1040	*Enbrel* Etanercept※[日]発売	(関節リウマチ)Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDS)		Immunex Corporation 51 University Street Seattle, WA 98101 License 1132	11/02/1998
	Enbrel Etanercept Letter		103795 / 5125	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	11/25/2003
	Enbrel Etanercept Letter		103795 / 5123	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
	Enbrel Etanercept Letter		103795 / 5110	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	10/17/2003
	Enbrel Etanercept Letter		103795 / 5102	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	8/21/2003
	Enbrel Etanercept Letter		103795 / 5099	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	10/9/2003
	Enbrel Etanercept Letter	Rheumatoid arthritis indication.	103795 / 5097	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
	Enbrel Etanercept Letter	Revision to Precautions and Adverse Reactions sections of the package insert to include patients with heart failure.	103795 / 5055	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
	Enbrel Etanercept	Revised Package Insert: Information regarding concurrent Etanercept and Anakinra therapy	103795 / 5109	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	6/5/2003
1040	Enbrel Etanercept	New Indication: Reducing signs and symptoms of active arthritis in patients with psoriatic arthritis	103795 / 5034	Immunex Corp 51 University Street Seattle, WA 18370 License 1132	1/15/2002
1040	Enbrel Etanercept	Updated Labeling: Higher frequency of adverse events associated with multiple doses	103795 / 5016	Immunex Corp 51 University Street Seattle, WA 18370 License 1132	1/15/2002
1040	Enbrel Etanercept	Revised Package Insert: Revise the Clinical Studies and Adverse Reactions sections to reflect three-year safety and efficacy information in rheumatoid arthritis patients	103795 / 5051	Immunex Corp 51 University Street Seattle, WA 18370 License 1132	9/12/2002
1040	*Enbrel* Etanercept	Expanded indication: Reducing the signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis, including those who have not previously failed treatment with a DMARD		Immunex Corporation 51 University Street Seattle, WA License 1132	6/6/2000
1040	*Enbrel* Etanercept	Expanded Indication: Treatment of polyarticular course juvenile rheumatoid arthritis (JRA)		Immunex Corporation 51 University Street Seattle, WA 98101 License 1132	05/27/1999
	*Epogen* Epoetin alfa	Pediatric Use		Amgen, Inc. 1840 DeHavilland Drive Thousand Oaks, CA 91320 License 1080	07/26/1999
1184	Erbitux/アービタックス Cetuximab※[日BMS]発売2008.9.19	((結腸・直腸癌))Erbitux is a monoclonal antibody that targets a protein called the epidermal growth factor receptor (EGFR).	125084 / 0	ImClone Systems, Incorporated License 1695	2/12/2004
1165	*Fabrazyme* Agalsidase beta	For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types	103979 / 0	Genzyme Corp One Kendall Square Cambridge, MA 02139-1562 License 1596	4/24/2003
1039	*Herceptin*/「ハーセプチン(R)」 Trastuzumab※[日]中外・発売	(乳癌)Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease		Genentech, Inc. 1 DNA Way S. San Francisco, CA 94080 License 1048	09/25/1998
	Herceptin Trastuzumab Letter		103792 / 5046	Genentech, Inc 1 DNA Way South San Francisco, CA 94080 License 1048	10/16/2003
	Herceptin Trastuzumab	Revise Package Insert: Include Vysis PathVysion HER2 DNA Probe, a FISH test for detecting HER2 gene amplification as a method to select patients for therapy	103792 / 5008	Genentech, Inc 1 DNA Way South San Francisco, CA 94080 License 1048	8/28/2002
	Herceptin Trastuzumab	Updated labeling: Median survival	103792 / 5004	Genentech Inc 1 DNA Way South San Francisco, CA 94080 License 1048	12/11/2001
	Herceptin Trastuzumab	Changes to the package insert, product container, and package to clarify the instructions for reconstitution		Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 License 1048	2/09/2000
1153	*Humira*/ヒュミラ(R) Adalimumab※[日]アボット発売2008.6.18	(関節リウマチ)For reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be used alone or in combination with Methotrexate (MTX) or other DMARDs.	125057 / 0	Abbott Laboratories 200 Abbott Park Road D-491, AP30�1E Abbott Park, IL 60064-6157 License 0043	12/31/2002
	*Indiclor* Indium-In-111 Chloride Sterile Solution	Addition of a "Geriatric Use" subsection in the package insert	19862 / 12	Medi-Physics, Inc, dba Amersham Health 101 Carnegie Center Princeton, NJ 08540	4/24/2003
	*Indiclor* Indium In-111 Chloride Sterile Solution	Use in radiolabeling Ibritumomab Tiuxetan (Zevalin) and remove use in radiolabeling Imciromab Pentetate (Myoscint)	19-862 / 006	Medi-Physics, Inc d.b.a. Amersham Health 101 Carnegie Center Princeton, NJ 08540	2/19/2002
	Indium In-111 Chloride Sterile Solution	Use in radiolabeling Ibritumomab Tiuxetan (Zevalin) and remove use in radiolabeling Imciromab Pentetate (Myoscint)	19-841 / 003	Mallinkrodt, Inc P.O.Box 5840 675 McDonnell Boulvard St. Louis, MO 63134	2/19/2002
	*Infergen* Interferon alfacon-1	Treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum anti-bodies and/or the presence of HCV RNA		Amgen, Inc.,Amgen Center 1840 DeHavilland Dr. Thousand Oaks, CA. License 1080	10/06/1997
	Infergen Interferon alfacon-1	Revised: To provide a Medication Guide	103663 / 5011	InterMune, Inc 3280 Bayshore Blvd Brisbane, CA 94005 License 1626	11/4/2002
	*Infergen* Interferon alfacon-1	Expanded Indication: Subsequent treatment of HCV-infected patients who have tolerated an initial course of Interferon therapy with 15 ug of Interferon alfacon-1 for 48 weeks		Amgen, Inc. 1 Amgen Center Dr. Thousand Oaks, CA 91320-1789 License 1080	12/22/1999
	*Infergen* Interferon alfacon-1	Expanded Indication: Subsequent treatment of HCV-infected patients who have tolerated an initial course of interferon therapy		Amgen, Inc. Amgen Center 1840 DeHavilland Dr. Thousand Oaks, CA 91320	10/06/1997
	Interferon alfa-2a	Removal of Kaposi's sarcoma indication.	103145/5026	Hoffman-LaRoche	9/10/2003
	*Intron A* Interferon alfa-2	New Indication: For treatment of hepatitis B in pediatric patients		Schering Corporation 2000 Galloping Hill Road Kenilworth, NJ 07033 License 0994	08/18/1998
	*Intron A* Interferon alfa-2	Expanded Indication: Extend therapy duration for chronic hepatitis C from 6 months to 18-24 months		Schering Corporation 2000 Galloping Hill Rd Kenilworth, NJ 07033 License 0994	03/26/1997
	*Intron A* Interferon alfa-2	New Indication: Treatment of follicular lymphoma in conjunction with chemotherapy		Schering Corporation 2000 Galloping Hill Rd. Kenilworth, NY 07033 License 0994	11/06/1997
1124	Kineret Anakinra	Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDS)	103950/0	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1789 License 1080	11/14/2001
	Kineret Anakinra Letter		103950 / 5019	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320 License 1080	8/21/2003
	Kineret Anakinra	Revised Package Insert: Include information on an increased risk of serious infections when used with Etanercept and a revised definition of the threshold for neutropenia	103950 / 5013	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320 License 1080	6/27/2003
1109	MYOBLOC Botulinum Toxin Type B	Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain	103846/0	Elan Pharmaceuticals 800 Gateway Boulevard S. San Francisco, CA 94080 License 1579	12/8/2000
	*Myoscint* Imciromab Pentetate※[日]未	Cardiac imaging agent for detection of myocardial necrosis		Centocor B.V. 2300 AG Leiden Einsteinweg 101 P.O. Box 251 NETHERLANDS License 1178	07/03/1996
1130	*Neulasta* Pegfilgrastim	To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia	125031 / 0	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1799 License 1080	1/31/2002
1032	*Neumega* Oprelvekin	Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia		Genetics Institute, One Burtt Road Andover, MA 01810 License 1163	11/25/1997
	Neumega Oprelvekin	Revised Package Insert: Update the Warnings and Precautions sections and to add important safety information	103694 / 1009	Genetics Institute, Inc Wyeth Pharmaceuticals 150 North Radnor-Chester Road License 1163	9/18/2002
	Neumega Oprelvekin	Revised Package Insert: To state that a safe and effective dose has not been established for pediatric patients and to add important new safety information	103694 / 5004	Genetics Institute, Inc Wyeth Pharmaceuticals 150 North Radnor-Chester Road License 1163	9/18/2002
	Neupogen Filgrastim	Revised Package Insert: Include updated information regarding adult respiratory distress syndrome and splenic rupture	103353 / 5001	Amgen, Incorporated One Amgen Center Drive Thousand Oaks, CA 91320-1799 License 1080	5/29/2002
	*Neupogen* Filgrastim	New Indication: For use in Acute Myeloid Leukemia		Amgen, Inc. 1840 DeHavilland Dr. Thousand Oaks, CA 91320-1789 License 1080	04/02/1998
	*Ontak* Denileukin diftitox	Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor		Seragen, Inc. 97 South Street Hopkinton, MA 01748 License 1258	02/05/1999
1151	*PEGASYS* Peginterferon alfa-2a	Treatment of adults with chronic hepatitis C who have compensated liver disease and who have not been previously treated with interferon alfa	103964 / 0	Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	10/16/2002
1151	PEGASYS Peginterferon alfa-2a	Expanded Indication for Use: Combination therapy with Ribavirin, USP (Copegus), for the treatment of chronic hepatitis C virus infection	103964 / 5000	Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ, 07110-1199 License 0136	12/3/2002
1107	PEG-Intron Peginterferon alfa-2b	Treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease and are at least 18 years of age	103949/0	Schering Corp 2000 Galloping Hill Road Kenilworth, NJ 07033 License 0994	1/19/2001
1107	PEG-Intron Peginterferon alfa-2b	Expanded Indication: Combination therapy with Ribavirin, USP (Rebetol), for treatment of chronic hepatitis C	103949 / 5002	Schering Corporation 2000 Galloping Hill Road Kenilworth, NJ 07033 License 0994	8/7/2001
	Proleukin Aldesleukin	New Indication: Treatment of metastatic melanoma		Chiron Corporation 4560 Horton Street Emeryville, CA 94608 License 1106	01/09/1998
	ProstaScint Capromab Pendetide※[日]未	(前立腺癌診断)Labeled with Indium 111 for imaging of prostatic carcinoma		Cytogen Corp. 600 College Road East Princeton, NJ 08540 License No. 1164	10/28/1996
	*Pulmozyme* Dornase alfa	Expanded Indication: Pediatric use in infants 3 months to 2 years, and children 2 to 4 years old		Genentech, Inc. 460 Point San Bruno Boulevard S. San Francisco, CA 94080-4990 License 1048	02/24/1998
	Raptiva EFALIZUMAB※[日]未 Letter	(乾癬)	125075/0	Genentech	10/27/03
1141	*Rebif* Interferon beta-1a	Treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability	103780 / 0	Serono, Inc One Technology Place Rockland, MA 02370 License 1574	3/7/2002
	Rebif Interferon beta-1a	Revised Package Insert: Final pivotal study report that confirms the results of 48 week data	103780 / 5010	Serono, Inc One Technology Place Rockland, MA 02370 License 1574	5/2/2003
1031	*Regranex* Becaplermin	Treatment of diabetic ulcers		OMJ Pharmaceuticals, Inc. Carr. #2, Km. 45.6 Bo. Campo Alegre Manati, PR 00674 License 1196	12/16/1997
1040 1047	*Remicade*/レミケード(R)点滴静注用100 Infliximab※[日]田辺三菱・発売2002.5.31(クローン病)追加承認2003.7.17(リウマチ)	(クローン病)Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s)		Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	08/24/1998
	*Remicade* Infliximab Letter	Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet.	103772 / 5056	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	09/03/2003
	*Remicade* Infliximab Letter	Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet.	103772 / 5020	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	09/03/2003
	Remicade Infliximab	Indication for Use: Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease	103772 / 5032	Centocor, Inc 200 Great Valley Parkway Malvern, PA 10355-1307 License 1242	4/1/2003
1040 1047	Remicade Infliximab	(関節リウマチ)Expanded Indication: Improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate	103772 / 5004	Centocor, Inc 200 Great Valley Parkway Malvern, PA License 1242	2/27/2002
1040 1047	Remicade Infliximab	Expanded Indication: Reducing signs and symptoms, and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy	103772 / 5012	Centocor, Inc 200 Great Valley Parkway Malvern, PA License 1242	6/28/2002
1040 1047	*Remicade* Infliximab	Expanded Indication: Inhibition of progression of structural damage in patients with rheumatoid arthritis who have had an inadequate response to methotrexate	103772/1007	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	12/29/2000
1040 1047	*Remicade* Infliximab	New Indication: For reduction in signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to Methotrexate		Centocor, Inc. 200 Great Valley parkway Malvern, PA 19355 License 1242	11/10/1999
	*ReoPro* Abciximab※[日]日本セントコアP2中断？	Expanded Indication: Treatment of a broader range of patients undergoing percutaneous coronary intervention; revised dosage and patient management to reduce bleeding		Centocor B.V. Einsteinweg 101, P.O. Box 251 300 AG Leiden NETHERLANDS License 1178	11/05/1997
	*ReoPro* Abciximab	Expanded Indication: Treatment of patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours		Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/05/1997
	*ReoPro* Abciximab Letter		103575/5025	Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/21/2003
	*ReoPro* Abciximab Letter		103575/5022	Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/21/2003
	Retavase Reteplase	Treatment of acute myocardial infarction in adults		Boehringer Mannheim Werk Penzberg GmbH Nonnenwald 2 82377 Penzberg Federal Republic of Germany License No. 1211	10/30/1996
1029	RITUXAN/リツキサン Rituximab※[日]中外・全薬工業が発売	(非ホジキンリンパ腫)Treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma		Genentech, Inc. 1 DNA Way S. San Fran., CA 94080 License 1048	11/26/1997
	Rituxan Rituximab Letter	Revision of Adverse Reactions Section of the package insert.	103737 / 5023	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA License 1235	10/9/2003
1144	Rituxan Rituximab	Labeling Change: Use of Rituximab as a component of the Zevalin (Ibritumomab Tiuxetan) therapeutic regimen	103737 / 5005	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA License 1235	2/19/2002
1029	Rituximab Formulated Bulk (For Further Manufacturing Use)	For further manufacture to Rituximab under shared manufacturing arrangement with Genentech, Inc.		IDEC Pharm. Corp. 11011 Torreyana Road San Diego, CA 92121 License 1235	11/26/1997
	Roferon-A Interferon alfa-2a	Revised labeling: To provide for a Medication Guide	103145 / 5010	Hoffman La-Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	3/14/2003
1151	Roferon-A Interferon alfa-2a	Revised Package Insert: Revise the Warnings section to include related to ophthalmologic disorders	103145 / 5015	Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	8/15/2002
	*Roferon-A* Interferon alfa-2	New Dosage Regimen: An induction regimen of 6 MIU three times a week for 12 weeks followed by the standard regimen given for an additional 12 to 36 weeks		Hoffman-La-Roche, Inc. 340 Kingsland Street Building 719/4 Nutley, NJ 07110-1199 License 0136	11/17/1999
1036	*Simulect*/「シムレクト注射用20mg」 Basiliximab※[日]ノバルティス発売2002.4.26「シムレクト小児用静注用10mg」は承認2008.6	(腎移植後の急性拒絶反応の抑制)For the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids		Novartis Pharmaceutical Corporation 59 Route 10 East Hanover, NJ 07930-1080 License 1244	05/12/1998
	Simulect Basiliximab Letter		103764 / 5040	Novartis Pharmaceutical Corp One Health Plaza East Hanover, NJ 07936-1080 License 1244	11/14/2003
	Simulect Basiliximab	New Dosage: Single dose 10 mg strength	103764 / 5037	Novartis Pharmaceutical Corp One Health Plaza East Hanover, NJ 07936-1080 License 1244	1/2/2003
	Simulect Basiliximab	New/Expanded Indication: Use in renal transplantation in combination with triple immunosuppressive therapy; use in pediatric renal transplantation; and use of an IV bolus injection	103764 / 5003	Novartis Pharmaceutical Corp. 59 Route 10 East Hanover, NJ 7936-1080 License 1244	3/23/2001
1043	*Synagis*/シナジス筋注用 Palivizumab※[日]アボットが発売	(RSV予防)Prophylaxis of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk of RSV disease		MedImmune, Inc. 35 West Watkins Mill Road Gaithersburg, MD 20878 License 1252	06/19/1998
	Synagis Palivizumab	Revised Package Insert:Revise Warnings and Adverse Reactions sections to include anaphylaxis and to revise the Immunogenicity subsection	103770 / 5022	Medimmune, Incorporated 25 West Watkins Mill Road License 1252	10/23/2002
1092	TNKase Tenecteplase	Reduction of mortality associated with acute myocardial infarction (AMI)		Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/02/2000
	*Verluma* Nofetumomab※[日]未	(小細胞肺癌の診断) Imaging agent for detection of extensive stage disease in patients with biopsy-confirmed, previously untreated, small cell lung cancer		Dr. Karl Thomae GmbH Birkendorfter Strasse 65 88397 Biberach/Riss GERMANY License 1199	08/20/1996
1124	Xigris Drotrecogin alfa (activated)	Reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II)	125029/0	Eli Lilly & Co Lilly Corporate Center Indianapolis, IN 46285 License 1611	11/21/2001
1163	*Xolair*/ゾレア Omalizumab※[日]ノバルティス・部会審議中	(気管支喘息)For adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids	103976 / 0	Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/20/2003
1036	*Zenapax* Daclizumab※[日]未	(移植腎の急性拒絶反応) Prophylaxis of acute renal allograft rejection		Hoffman-La Roche Inc. 340 Kingsland Street Bldg. 1, 2nd Floor Nutley, NJ 07110-1199 License 0136	12/10/1997
	Zenapax Daclizumab	Revised Package Insert: Includes pediatric use	103749 / 5006	Hoffman-La Roche, Inc 340 Kingsland Street, Bldg. 1, 2nd floor Nutley, NJ 07110-1199 License 0136	7/29/2002
1144	*Zevalin*/ゼバリン Ibritumomab Tiuxetan※[日]バイエル薬品・承認2008.1.25	(低悪性度B細胞性非ホジキンリンパ腫をターゲットとする放射免疫療法。) Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin's lymphoma; the therapeutic regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan	125019 / 0	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA 92121 License 1235	2/19/2002

■FDA - CBER: Products　→CDER移管品目：年月順

　移管前は、年月順だったのが、現在は製品名順となっている。　年月順は、消去するにはまだ有用なので、リンクを更新して以下に残す。　最終更新2004.4.7

●Biological License Application Approvals

　整列＝承認日順; Last update: 2004.1.12

●CBER - 2004 Biological License Application Approvals - Approvals through December

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1184 Avastin
(bevacizumab)
Package Insert First-line treatment for patients with metastatic colorectal cancer 125085/0 Genentech, Inc.
-1 DNA Way MS#48, South San Francisco, CA 95080;
Lincense 1048 2/26/2004

1184 Erbitux
Cetuximab Erbitux is a monoclonal antibody that targets a protein called the epidermal growth factor receptor (EGFR). 125084 / 0 ImClone Systems, Incorporated
License 1695 2/12/2004

　　

●CBER - 2003 Biological License Application Approvals - Approvals through December

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1145 Amevive
Alefacept Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy 125036 / 0 Biogen, Inc
14 Cambridge Center
Cambridge, MA 02142
License 1204 1/30/2003

　 Avonex
Interferon beta-1a Revised Package Insert:
To include safety and efficacy data from a study of patients who experienced a single clinical exacerbation of multiple sclerosis and to provide a Medication Guide 103628 / 5001 Biogen, Inc
14 Cambridge Center
Cambridge, MA 02142
License 1204 1/31/2003

　 Betaseron
Interferon beta-1b Revised Package Insert:
Revised the Clinical Studies section (include data from two studies conducted in patients with secondary progressive multiple sclerosis (MS)), Adverse Reactions and Warnings sections (include new safety information); and provided a Medication Guide 103471 / 1039 Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
License 1106 3/14/2003

　 Roferon-A
Interferon alfa-2a Revised labeling:
To provide for a Medication Guide 103145 / 5010 Hoffman La-Roche, Inc
340 Kingsland Street
Nutley, NJ 07110-1199
License 0136 3/14/2003

　 Remicade
Infliximab Indication for Use:
Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn痴 disease 103772 / 5032 Centocor, Inc
200 Great Valley Parkway
Malvern, PA 10355-1307
License 1242 4/1/2003

1165 Fabrazyme
Agalsidase beta For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types 103979 / 0 Genzyme Corp
One Kendall Square
Cambridge, MA 02139-1562
License 1596 4/24/2003

1168 Aldurazyme
Laronidase For patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. Laronidase has been shown to improve pulmonary function and walking capacity. Laronidase has not been evaluated for effects on the central nervous system manifestations of the disorder 125058 / 0 Biomarin Pharmaceutical Inc
371 Bel Marin Keys Boulevard
Suite 210
Novato, CA 94949
License 1649 4/30/2003

　 Rebif
Interferon beta-1a Revised Package Insert:
Final pivotal study report that confirms the results of 48 week data 103780 / 5010 Serono, Inc
One Technology Place
Rockland, MA 02370
License 1574 5/2/2003

　 Simulect
Basiliximab For the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids Novartis Pharmaceutical Corporation
59 Route 10
East Hanover, NJ 07930-1080
License 1244 05/12/1998

　 Avonex
Interferon beta-1a Indication for Use:
To include an HSA-free liquid formulation in a prefilled syringe as an alternate dosage form 103628 / 5021 Biogen, Inc
14 Cambridge Center
Cambridge, MA 02142
License 1204 5/28/2003

　 Enbrel
Etanercept Revised Package Insert:
Information regarding concurrent Etanercept and Anakinra therapy 103795 / 5109 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 6/5/2003

1163 Xolair
Omalizumab For adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids 103976 / 0 Genentech, Inc
1 DNA Way
South San Francisco, CA 94080-4990
License 1048 6/20/2003

1168 Bexxar
Tositumomab and Iodine I-131 Tositumomab Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy 125011 / 0 Corixa Corp
1124 Columbia Street
Suite 200
Seattle, WA 98104
License 1614 6/27/2003

　 Kineret
Anakinra Revised Package Insert:
Include information on an increased risk of serious infections when used with Etanercept and a revised definition of the threshold for neutropenia 103950 / 5013 Amgen, Inc
One Amgen Center Drive
Thousand Oaks, CA 91320
License 1080 6/27/2003

　 Enbrel
Etanercept
Letter
103795 / 5123 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 7/24/2003

　 Enbrel
Etanercept
Letter
Rheumatoid arthritis indication. 103795 / 5097 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 7/24/2003

　 Enbrel
Etanercept
Letter
Revision to Precautions and Adverse Reactions sections of the package insert to include patients with heart failure. 103795 / 5055 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 7/24/2003

　 Enbrel
Etanercept
Letter
103795 / 5102 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 8/21/2003

　 Kineret
Anakinra
Letter
103950 / 5019 Amgen, Inc
One Amgen Center Drive
Thousand Oaks, CA 91320
License 1080 8/21/2003

　 Remicade
Infliximab
Letter
Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet. 103772 / 5056 Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 19355
License 1242 09/03/2003

　 Remicade
Infliximab
Letter
Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet. 103772 / 5020 Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 19355
License 1242 09/03/2003

　 Interferon alfa-2a Removal of Kaposi's sarcoma indication. 103145/5026 Hoffman-LaRoche 9/10/2003

　 Enbrel
Etanercept
Letter
103795 / 5099 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 10/9/2003

　 Rituxan
Rituximab
Letter
Revision of Adverse Reactions Section of the package insert. 103737 / 5023 IDEC Pharmaceuticals Corp
3030 Callan Road
San Diego, CA
License 1235 10/9/2003

　 Betaseron
Interferon beta-1b
Letter
Label
Provides for the use of diluent in a prefilled syringe, instead of a vial configuration. 103471 / 5032 Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
License 1106 10/10/2003

　 Herceptin
Trastuzumab
Letter
103792 / 5046 Genentech, Inc
1 DNA Way
South San Francisco, CA 94080
License 1048 10/16/2003

　 Enbrel
Etanercept
Letter
103795 / 5110 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 10/17/2003

　 Raptiva EFALIZUMAB
Letter
125075/0 Genentech 10/27/03

　 Simulect
Basiliximab
Letter
103764 / 50340 Novartis Pharmaceutical Corp
One Health Plaza
East Hanover, NJ 07936-1080
License 1244 11/14/2003

　 ReoPro
Abciximab
Letter
103575/5025 Centocor B.V.
Einsteinweg 101,
P.O. Box 251
2300 AG Leiden
NETHERLANDS
License 1178 11/21/2003

　 ReoPro
Abciximab
Letter
103575/5022 Centocor B.V.
Einsteinweg 101,
P.O. Box 251
2300 AG Leiden
NETHERLANDS
License 1178 11/21/2003

●CBER - 2002 Biological License Application Approvals - Approvals through December

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1130 Neulasta
Pegfilgrastim To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia 125031/0 Amgen, Incorporated
one Amgen Center Drive
Thousand Oaks, CA 91320-1799
License 1080 1/31/2002

1144 Zevalin
Ibritumomab Tiuxetan Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin's lymphoma; the therapeutic regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan 125019/0 IDEC Pharmaceuticals Corp
3030 Callan Road
San Diego, CA 92121
License 1235 2/19/2002

1141 Rebif
Interferon beta-1a Treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability 103780/0 Serono, Inc
One Technology Place
Rockland, MA 02370
License 1574 3/7/2002

1143 Elitek
Rasburicase Initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid 103946/0 Sanofi-Synthelabo, Inc
9 Great Valley Parkway
P.O. Box 3026
Malvern, PA 19355
License 1294 7/12/2002

1151 PEGASYS
Peginterferon alfa-2a Treatment of adults with chronic hepatitis C who have compensated liver disease and who have not been previously treated with interferon alfa 103964/0 Hoffman-La Roche, Inc
340 Kingsland Street
Nutley, NJ 07110-1199
License 0136 10/16/2002

1153 Humira
Adalimumab For reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be used alone or in combination with Methotrexate (MTX) or other DMARDs. 125057/0 Abbott Laboratories
200 Abbott Park Road
D-491, AP30�1E
Abbott Park, IL 60064-6157
License 0043 12/31/2002

●CBER - 2001 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1107 PEG-Intron
Peginterferon alfa-2b Treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease and are at least 18 years of age 103949/0 Schering Corp
2000 Galloping Hill Road
Kenilworth, NJ 07033
License 0994 1/19/2001

　 Campath
Alemtuzumab Treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy 103948/0 Millennium and ILEX Partners, LP
75 Sidney Street
Cambridge, MA 02139
License 1289 5/7/2001

1120 Aranesp
Darbepoetin alfa Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis 103951/0 Amgen, Incorporated
One Amgen Center Drive
Thousand Oaks, CA 91320-1789
License 1080 9/17/2001

1124 Kineret
Anakinra Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDS) 103950/0 Amgen, Inc
One Amgen Center Drive
Thousand Oaks, CA 91320-1789
License 1080 11/14/2001

1124 Xigris
Drotrecogin alfa (activated) Reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II) 125029/0 Eli Lilly and Co
Lilly Corporate Center
Indianapolis, IN 46285
License 1611 11/21/2001

●CBER - 2000 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1092 TNKase
Tenecteplase Reduction of mortality associated with acute myocardial infarction (AMI) Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
License 1048 6/02/2000

1109 MYOBLOC
Botulinum Toxin Type B Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain 103846/0 Elan Pharmaceuticals
800 Gateway Boulevard
S. San Francisco, CA 94080
License 1579 12/8/2000

●CBER - 1999 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Ontak
Denileukin diftitox Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor Seragen, Inc.
97 South Street
Hopkinton, MA 01748
License 1258 02/05/1999

　 Wellferon
Interferon alfa-n1, Lymphoblastoid Treatment of chronic hepatitis C in patients 18 years of age or older without decompensated liver disease Glaxo Wellcome Inc.
Five Moore Drive
Research Triangle Park, NC 27709
License 0129 03/25/1999

●CBER - 1998 Biological License Application Approvals

　 Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

1036 Simulect
Basiliximab For the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids Novartis Pharmaceutical Corporation
59 Route 10
East Hanover, NJ 07930-1080
License 1244 05/12/1998

1043 Synagis
Palivizumab Prophylaxis of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high risk of RSV disease MedImmune, Inc.
35 West Watkins Mill Road
Gaithersburg, MD 20878
License 1252 06/19/1998

1040
1047 Remicade
Infliximab Treatment of moderately to severely active Crohn's disease for the reduction of the signs and symptoms in patients who have an inadequate response to conventional therapies; and treatment of patients with fistulizing Crohn's disease for the reduction in the number of draining enterocutaneous fistula(s) Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 19355
License 1242 08/24/1998

1039 Herceptin
Trastuzumab Treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease Genentech, Inc.
1 DNA Way
S. San Francisco, CA 94080
License 1048 09/25/1998

1040 Enbrel
Etanercept Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis in patients who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDS) Immunex Corporation
51 University Street
Seattle, WA 98101
License 1132 11/02/1998

●CBER - 1997 Biological License Application Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Infergen
Interferon alfacon-1 Treatment of chronic hepatitis C virus (HCV) infection in patients 18 years of age or older with compensated liver disease who have anti-HCV serum anti-bodies and/or the presence of HCV RNA Amgen, Inc.,Amgen Center
1840 DeHavilland Dr.
Thousand Oaks, CA.
License 1080 10/06/1997

1032 Neumega
Oprelvekin Prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia Genetics Institute,
One Burtt Road
Andover, MA 01810
License 1163 11/25/1997

1029 RITUXAN
Rituximab Treatment of patients with relapsed or refractory low-grade or follicular, B-cell non-Hodgkin's lymphoma Genentech, Inc.
1 DNA Way S.
San Fran., CA 94080
License 1048 11/26/1997

1029 Rituximab Formulated Bulk (For Further Manufacturing Use) For further manufacture to Rituximab under shared manufacturing arrangement with Genentech, Inc. IDEC Pharm. Corp.
11011 Torreyana Road
San Diego, CA 92121
License 1235 11/26/1997

1036 Zenapax
Daclizumab Prophylaxis of acuterenal allograft rejection Hoffman-La Roche Inc.
340 Kingsland Street
Bldg. 1, 2nd Floor
Nutley, NJ 07110-1199
License 0136 12/10/1997

1031 Regranex
Becaplermin Treatment of diabetic ulcers OMJ Pharmaceuticals, Inc.
Carr. #2, Km. 45.6
Bo. Campo Alegre
Manati, PR 00674
License 1196 12/16/1997

1031 Becaplermin Concentrate For further manufacture under a shared manufacturing arrangement with OMJ Pharmaceuticals, Inc. Chiron Corporation
4560 Horton Street
Emeryville, CA 94608
License 1106 12/16/1997

●CBER - 1996 Biological License Application Approvals

　 Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 AVONEX
Interferon beta-1a Treatment of multiple sclerosis (orphan indication) Biogen, Inc.
14 Cambridge Center
Cambridge, MA 02142
License 1204 05/17/1996

　 Verluma
Nofetumomab Imaging agent for detection of extensive stage disease in patients with biopsy-confirmed, previously untreated, small cell lung cancer Dr. Karl Thomae GmbH
Birkendorfter Strasse 65
88397 Biberach/Riss
GERMANY
License 1199 08/20/1996

　 ProstaScint
Capromab Pendetide Labeled with Indium 111 for imaging of prostatic carcinoma Cytogen Corp.
600 College Road East
Princeton, NJ 08540
License No. 1164 10/28/1996

　 Retavase
Reteplase Treatment of acute myocardial infarction in adults Boehringer Mannheim
Werk Penzberg GmbH
Nonnenwald 2
82377 Penzberg
Federal Republic of Germany
License No. 1211 10/30/1996

　 ●Biological License Application Supplement Approvals

整列＝承認日順; Last update: 2004.1.12

●CBER - 2003 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Simulect
Basiliximab New Dosage:
Single dose 10 mg strength 103764 / 5037 Novartis Pharmaceutical Corp
One Health Plaza
East Hanover, NJ 07936-1080
License 1244 1/2/2003

　 Avonex
Interferon beta-1a Revised Package Insert:
to include safety and efficacy data from a study of patients who experienced a single clinical exacerbation of multiple sclerosis and to provide a Medication Guide 103628 / 5001 Biogen, Inc
14 Cambridge Center
Cambridge, MA 02142
License 1204 1/31/2003

　 Betaseron
Interferon beta-1b Revised Package Insert:
Revised the Clinical Studies section, Adverse Reactions and Warnings sections, and provided a Medication Guide 103471 / 1039 Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
License 1106 3/14/2003

　 Roferon-A
Interferon alfa-2a Revised:
To provide for a Medication Guide 103145 / 5010 Hoffman La-Roche, Inc
340 Kingsland Street
Nutley, NJ 07110-1199
License 0136 3/14/2003

　 Remicade
Infliximab Indication for Use:
Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease
103772 / 5032 Centocor, Inc
200 Great Valley Parkway
Malvern, PA 10355-1307
License 1242 4/1/2003

　 Rebif
Interferon beta-1a Revised Package Insert:
Final pivotal study report that confirms the results of 48 week data 103780 / 5010 Serono, Inc
One Technology Place
Rockland, MA 02370
License 1574 5/2/2003

　 Avonex
Interferon beta-1a Indication for Use:
To include an HSA-free liquid formulation in a prefilled syringe as an alternate dosage form 103628 / 5021 Biogen, Inc
14 Cambridge Center
Cambridge, MA 02142
License 1204 5/28/2003

　 Enbrel
Etanercept Revised Package Insert:
Information regarding concurrent Etanercept and Anakinra therapy 103795 / 5109 Immunex Corp
One Amgen Center Drive
Mailstop 24-2-C
Thousand Oaks, CA 91320
License 1132 6/5/2003

　 Kineret
Anakinra Revised Package Insert:
Include information on an increased risk of serious infections when used with Etanercept and a revised definition of the threshold for neutropenia 103950 / 5013 Amgen, Inc
One Amgen Center Drive
Thousand Oaks, CA 91320
License 1080 6/27/2003

　 Remicade
Infliximab
Letter
Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet. 103772 / 5056 Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 19355
License 1242 09/03/2003

　 Remicade
Infliximab
Letter
Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet. 103772 / 5020 Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 19355
License 1242 09/03/2003

　 Interferon alfa-2a Removal of Kaposi's sarcoma indication. 103145/5026 Hoffman-LaRoche 9/10/2003

　 Rituxan
Rituximab
Letter
Revision of Adverse Reactions Section of the package insert. 103737 / 5023 IDEC Pharmaceuticals Corp
3030 Callan Road
San Diego, CA
License 1235 10/9/2003

　 Betaseron
Interferon beta-1b
Letter
Label
Provides for the use of diluent in a prefilled syringe, instead of a vial configuration. 103471 / 5032 Chiron Corp
4560 Horton Street
Emeryville, CA 94608-2916
License 1106 10/10/2003

●CBER - 2002 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

1040 Enbrel
Etanercept New Indication:
Reducing signs and symptoms of active arthritis in patients with psoriatic arthritis 103795
/5034 Immunex Corp
51 University Street
Seattle, WA 18370
License 1132
License 1080 1/15/2002

1040 Enbrel
Etanercept Updated Labeling:
Higher frequency of adverse events associated with multiple doses 103795/5016 Immunex Corp
51 University Street
Seattle, WA 18370
License 1132 1/15/2002
1144 　Rituxan
Rituximab Labeling Change:
Use of Rituximab as a component of the Zevalin (Ibritumomab Tiuxetan) therapeutic regimen 103737
/5005 IDEC Pharmaceuticals Corp
3030 Callan Road
San Diego, CA
License 1235 2/19/2002

1040
1047 Remicade
Infliximab Expanded Indication:
Improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate 103772
/5004 Centocor, Inc
200 Great Valley Parkway
Malvern, PA
License 1242 2/27/2002

1131 BOTOX COSMETIC
Botulinum Toxin Type A New Indication:
Temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients 65 years of age 103000
/5000 Allergan, Inc
2525 Dupont Drive
P.O. Box 195
Irvine, CA 92713-9534
License 1145 4/12/2002

　 Activase
Alteplase Labeling Change: Addition of information regarding orolingual angioedema to the Precautions and Adverse Reactions sections, and bolding a statement in the Dosage and Administration section 103172
/5009 Genentech, Inc
1 DNA Way
South San Francisco, CA 94080-4990
License 1048 5/15/2002

1040
1047 Remicade
Infliximab Expanded Indication: Reducing signs and symptoms, and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy 103772
/5012 Centocor, Inc
200 Great Valley Parkway
Malvern, PA
License 1242 6/28/2002

　 Aranesp
Darbepoetin alfa New Indication: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy 103951
/5001 Amgen, Inc
One Amgen Center Drive
Thousand Oaks, CA
License 1080 7/19/2002

　 Zenapax
Daclizumab Revised Package Insert: Includes pediatric use 103749
/5006 Hoffman-La Roche, Inc
340 Kingsland Street, Bldg. 1, 2nd floor
Nutley, NJ 07110-1199
License 0136 7/29/2002

　 Elspar
Asparaginase Revised Package Insert: Add Geriatric Use subsection in the Precautions section 101063
/5012 Merck and Co, Inc
Sumneytown Pike
P.O. Box 4 UN-B121 West Point, PA 19486-0004
License 0002 8/1/2002

1151 Roferon-A
Interferon alfa-2a Revised Package Insert: Revise the Warnings section to include related to ophthalmologic disorders 103145
/5015 Hoffman-La Roche, Incorporated
340 Kingsland Street
Nutley, NJ 07110-1199
License 0136 8/15/2002

1040 Enbrel
Etanercept Updated Safety and Efficacy: Revised Clinical Studies and Adverse Reactions sections of the package insert to include a three-year safety and efficacy information in rheumatoid arthritis patients 103795
/5051 Immunex Corp
51 University St
Seattle, WA 98101
License 1132 9/12/2002

　 Neumega
Oprelvekin Revised Package Insert: Update the Warnings and Precautions sections and to add important safety information 103694
/1009 Genetics Institute, Incorporated
Wyeth Pharmaceuticals
150 North Radnor-Chester Road
License 1163 9/18/2002

1040 Enbrel
Etanercept Revised Package Insert:
Revise the Clinical Studies and Adverse Reactions sections to reflect three-year safety and efficacy information in rheumatoid arthritis patients 103795/5051 Immunex Corp
51 University Street
Seattle, WA 18370
License 1132 9/12/2002

1141 AVONEX
Interferon beta-1a Revised Package Insert:
Updated information regarding serum neutralizing antibodies 103628/5008 Biogen, Inc
14 Cambridge Center
Cambridge, MA 02142
License 1204 11/12/2002

1151 PEGASYS
Peginterferon alfa-2a Indication for Use:
Treatment of chronic hepatitis C virus infection 103964/5000 Hoffman-La Roche, Inc
340 Kingsland Street
Nutley, NJ, 07110-1199
License 0136 12/3/2002

●CBER - 2001 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Simulect
Basiliximab New/Expanded Indication:
Use in renal transplantation in combination with triple immunosuppressive therapy; use in pediatric renal transplantation; and use of an IV bolus injection 103764
/5003 Novartis Pharmaceutical Corp.
59 Route 10
East Hanover, NJ 7936-1080
License 1244 3/23/2001

1107 PEG-Intron
Peginterferon alfa-2b Expanded Indication:
Combination therapy with Ribavirin, USP (Rebetol), for treatment of chronic hepatitis C 103949
/5002 Schering Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033
License 0994 8/7/2001

　 Cathflo Activase
Alteplase New Indication:
Restoration of function to central venous access devices (as assessed by the ability to withdraw blood) 103172
/5003 Genentech Inc
1 DNA Way
South San Francisco, CA 94080
License 1048 9/4/2001

　 Herceptin
Trastuzumab Updated labeling:
Median survival 103792
/5004 Genentech Inc
1 DNA Way
South San Francisco, CA 94080
License 1048 12/11/2001

●CBER - 2000 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use STN Manufacturer/
License No. Approval Date

　 Herceptin
Trastuzumab Changes to the package insert, product container, and package to clarify the instructions for reconstitution Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080-4990
License 1048 2/09/2000

　 ACTIMMUNE
Interferon gamma-1b New Indication:
Delaying the time to disease progression in patients with severe, malignant osteopetrosis InterMune Pharmaceuticals, Inc.
3294 West Bayshore Road
Palo Alto, CA 94303
License 1267 2/10/2000

1040 Enbrel
Etanercept Expanded indication:
Reducing the signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis, including those who have not previously failed treatment with a DMARD Immunex Corporation
51 University Street
Seattle, WA
License 1132 6/6/2000

　 BOTOX
Botulinum Toxin Type A New Indication:
Treatment of cervical dystonia 103000
/1004 Allergan, Inc.
2525 Dupont Drive
P.O. Box 195
Irvine, CA 92713-9534
License 1145 12/21/2000

1040
1047 Remicade
Infliximab Expanded Indication:
Inhibition of progression of structural damage in patients with rheumatoid arthritis who have had an inadequate response to methotrexate 103772
/1007 Centocor, Inc.
200 Great Valley Parkway
Malvern, PA 19355
License 1242 12/29/2000

●CBER - 1999 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

1040 Enbrel
Etanercept Expanded Indication:
Treatment of polyarticular course juvenile rheumatoid arthritis (JRA) Immunex Corporation
51 University Street
Seattle, WA 98101
License 1132 05/27/1999

　 Epogen
Epoetin alfa Pediatric Use Amgen, Inc.
1840 DeHavilland Drive
Thousand Oaks, CA 91320
License 1080 07/26/1999

1040
1047 Remicade
Infliximab New Indication:
For reduction in signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to Methotrexate Centocor, Inc.
200 Great Valley parkway
Malvern, PA 19355
License 1242 11/10/1999

　 Roferon-A
Interferon alfa-2 New Dosage Regimen:
An induction regimen of 6 MIU three times a week for 12 weeks followed by the standard regimen given for an additional 12 to 36 weeks Hoffman-La-Roche, Inc.
340 Kingsland Street
Building 719/4
Nutley, NJ 07110-1199
License 0136 11/17/1999

　 Infergen
Interferon alfacon-1 Expanded Indication:
Subsequent treatment of HCV-infected patients who have tolerated an initial course of Interferon therapy with 15 ug of Interferon alfacon-1 for 48 weeks Amgen, Inc.
1 Amgen Center Dr.
Thousand Oaks, CA 91320-1789
License 1080 12/22/1999

●CBER - 1998 Biological License Application Supplement Approvals

ML Tradename/
Proper Name
Indication for Use Manufacturer/
License No.
Approval Date

　 Proleukin
Aldesleukin New Indication:
Treatment of metastatic melanoma Chiron Corporation
4560 Horton Street
Emeryville, CA 94608
License 1106
01/09/1998

　 Pulmozyme
Dornase alfa Expanded Indication:
Pediatric use in infants 3 months to 2 years, and children 2 to 4 years old Genentech, Inc.
460 Point San Bruno Boulevard
S. San Francisco, CA 94080-4990
License 1048
02/24/1998

　 Neupogen
Filgrastim New Indication:
For use in Acute Myeloid Leukemia Amgen, Inc.
1840 DeHavilland Dr.
Thousand Oaks, CA 91320-1789
License 1080
04/02/1998

　 Intron A
Interferon alfa-2 New Indication:
For treatment of hepatitis B in pediatric patients Schering Corporation
2000 Galloping Hill Road
Kenilworth, NJ 07033
License 0994 08/18/1998

●CBER - 1997 Biological License Application Supplement Approvals

ML Tradename/
Proper Name Indication for Use Manufacturer/
License No. Approval Date

　 Intron A
Interferon alfa-2 Expanded Indication:
Extend therapy duration for chronic hepatitis C from 6 months to 18-24 months Schering Corporation
2000 Galloping Hill Rd
Kenilworth, NJ 07033
License 0994 03/26/1997

　 Infergen
Interferon alfacon-1 Expanded Indication:
Subsequent treatment of HCV-infected patients who have tolerated an initial course of interferon therapy Amgen, Inc.
Amgen Center
1840 DeHavilland Dr.
Thousand Oaks, CA 91320 10/06/1997

　 ReoPro
Abciximab Expanded Indication:
Treatment of a broader range of patients undergoing percutaneous coronary intervention; revised dosage and patient management to reduce bleeding Centocor B.V.
Einsteinweg 101,
P.O. Box 251
300 AG Leiden
NETHERLANDS
License 1178 11/05/1997

　 ReoPro
Abciximab Expanded Indication:
Treatment of patients with unstable angina not responding to conventional medical therapy when percutaneous coronary intervention is planned within 24 hours Centocor B.V.
Einsteinweg 101,
P.O. Box 251
2300 AG Leiden
NETHERLANDS
License 1178 11/05/1997

　 Intron A
Interferon alfa-2 New Indication:
Treatment of follicular lymphoma in conjunction with chemotherapy Schering Corporation
2000 Galloping Hill Rd.
Kenilworth, NY 07033
License 0994 11/06/1997

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-------------------------------------

作成：2002.10.6　最終更新:2009.10.5　小菅博之

The Medical Letter日本語版
●参考資料
On Drugs and Therapeutics

●CBER - 1999 Biological License Application Approvals
ML	Tradename/ Proper Name	Indication for Use	Manufacturer/ License No.	Approval Date
	Whole Blood	Transfusion	Winter Haven Hospital, Inc. 460 First Street, North Winter Haven, FL 33881 License 1266	02/05/1999
	Red Blood Cells	Transfusion	Winter Haven Hospital, Inc. 460 First Street, North Winter Haven, FL 33881 License 1266	02/05/1999
	Plasma	Transfusion	Winter Haven Hospital, Inc. 460 First Street, North Winter Haven, FL 33881 License 1266	02/05/1999
	Nabi-HB Hepatitis B Immune Globulin (Human)	Treatment of acute exposure to HbsAg, perinatal exposure of infants born to HbsAg-positive mothers, sexual exposure to HbsAg-positive persons and household exposure of infants to persons with acute HBV infection	Nabi P.O. Box 310701 Boca Raton, FL 33431-0701 License 1022	03/24/1999
1181	NovoSeven Coagulation Factor VIIa (Recombinant)	Treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX	Novo Nordisk A/S Novo Alle DK-2880 Bagsvaerd DENMARK License 1261	03/25/1999
	Humate-P Antihemophilic Factor/von Willebrand Factor Complex (Human)	Used in adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia); in adult and pediatric patients for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease; and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate	Centeon Pharma G.m.b.H. P.O. Box 1230 D-35002 Marburg GERMANY License 1202	04/01/1999
	Cryoprecipitated AHF	Transfusion	Sarasota Community Blood Bank, Inc. 1760 Mound Street Sarasota, FL 34236-7761 License 1122	06/14/1999
	Plasma	Transfusion	Marathon County Blood Bank, Inc. 404 South 3rd Avenue Wausau, WI 54401 License 1093	07/16/1999
	Cryoprecipitated AHF	Transfusion	Northern California Community Blood Bank 2524 Harrison Avenue Eureka, CA 95501 License 0230	07/28/1999
	Cryoprecipitated AHF	Transfusion	Central California Blood Center 3445 North First Street Fresno, CA 93726 License 0315	08/12/1999
	Source Plasma	For further manufacture	DCI Biologicals Bryan, Inc. 1706 South 2nd St. Gallup, NM 87301 License 1275	08/13/1999
	Plasma	Transfusion	Northern California Community Blood Bank 2524 Harrison Avenue Eureka, CA 95501 License 0230	08/16/1999
	Platelets	Transfusion	Marathon County Blood Bank, Inc. 404 South Third Avenue Wausau, WI 54401-4639 License 1093	09/17/1999
	Whole Blood	Transfusion	Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276	12/17/1999
	Red Blood Cells	Transfusion	Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276	12/17/1999
	Platelets	Transfusion	Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276	12/17/1999
	Cryoprecipitated AHF	Transfusion	Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276	12/17/1999
	Plasma	Transfusion	Community Blood Center Of the Ozarks 2230 S. Glenstone Springfield, MO 65804 License 1276	12/17/1999
	Source Plasma	For further manufacture	PlasmaCare, Inc. 1128 Main Street Cincinnati, OH 45210 License 1278	12/30/1999
●CBER - 1998 Biological License Application Approvals
	Tradename/ Proper Name	Indication for Use	Manufacturer/ License No.	Approval Date
	Source Plasma	For further manufacture	Community Blood Centers of South Florida, Inc. 1700 North State Rd. 7 Lauderhill, FL 33313 License 0913	01/06/1998
	Source Plasma	For further manufacture	Seramed, Inc. 780 Park North Blvd. Clarkston, GA 30021 License 1237	01/16/1998
	HTLV-I p21E Antigen Human T-Lymphotropic Virus I & II	Shared manufacturing arrangement with Organon Teknika Corporation	Organon Teknika B.V. Boseind 15 5281 RM Boxtel, NETHERLANDS License 1103	01/17/1998
	Vironostika HTLV-I & II Microelisa System Human T-Lymphotropic Virus I & II	Used for detection of antibodies to HTLV-I/II in human serum or plasma	Organon Teknika Corporation 100 Akzo Avenue Durham, NC 27712 License 0956	01/17/1998
	Whole Blood	Transfusion	Dept. of Veterans Affairs Medical and Regional Office Center Blood Bank Dept. 1 VA Center Togus, ME 04330 License 1240	03/19/1998
	Tisseel VH Kit Fibrin Sealant	Used as an adjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by onventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical; and for closure of colostomies	Osterreichisches Institut fur Haemoderivate Ges.m.b.H. Industriestrasse 67 A-1220 Vienna AUSTRIA License 0258	05/01/1998
	VIPLAS/SD Pooled Plasma, Solvent Detergent Treated	For use in the treatment of patients with documented deficiencies of coagulation factors for which there are no concentrate preparations available, including congenital single-factor deficiencies of factors I, V, VII, XI, and XIII, and acquired multiple coagulation factor deficiencies; reversals of warfarin effect; and treatment of patients with thrombotic thrombocytopenic purpura (TTP)	V.I. Technologies, Inc. 155 Duryea Road P.O. Box 5119 Melville, NY 11747 License 0386	05/06/1998
	Source Plasma	For further manufacture	V.I. Technologies, Inc. 155 Duryea Road P.O. Box 5119 Melville, NY 11747 License 0386	05/12/1998
	Source Plasma	For further manufacture	International Enzymes, Inc. 1432-B South Mission Road Fallsbrook, CA 92028 License 1243	05/27/1998
	Source Leukocytes	For further manufacture	San Diego Blood Bank 440 Upas Street San Diego, CA 92103 License 0201	06/26/1998
	CERTIVA Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed	For the active immunization of persons 6 weeks to 7 years of age (prior to the seventh birthday)	North American Vaccine, Inc. 12103 Indian Creek Court Beltsville, MD 20705 License 1254	07/29/1998
	Diphtheria Toxoid Concentrate (For Further Manufacturing Use)	For further manufacture under shared arrangement with North American Vaccine, Inc.	Statens Seruminstitut 5, Artillerivej DK-2300 Copenhagen S DENMARK License 1255	07/29/1998
	Tetanus Toxoid Concentrate (For Further Manufacturing Use)	For further manufacture under shared arrangement with North American Vaccine, Inc.	Statens Seruminstitut 5, Artillerivej DK-2300 Copenhagen S DENMARK License 1255	07/29/1998
	Source Plasma	For further manufacture	San Diego Blood Bank 440 Upas Street San Diego, CA 92103 License 0201	08/19/1998
1053	RotaShield Rotovarus Vaccine, Live, Oral, Tetravalent	Primary immunization of infants at 2, 4, and 6 months of age	Wyeth Laboratories, Inc. Wasp & Biddle Streets P.O. Box 34 Marietta, PA 17547 License 0003	08/31/1998
	Cryoprecipitated AHF	Transfusion	Northern Illinois Blood Bank, Inc. 419 North Sixth Street Rockford, IL 61107 License 0249	09/01/1998
	Red Blood Cells	Transfusion	Arizona Blood Institute, Inc. 3915 East Broadway Blvd Tucson, AZ 86711 License 1225	10/08/1998
	Source Plasma	For further manufacture	West Tennessee Regional Blood Center, Inc. 828 North Parkway Jackson, TN 38305 License 0170	11/04/1998
	Whole Blood	Transfusion	Central Illinois Community Blood Bank 1134 South Seventh Street Springfield, IL 62703 License 1263	12/17/1998
	Red Blood Cells	Transfusion	Central Illinois Community Blood Bank 1134 South Seventh Street Springfield, IL 62703 License 1263	12/17/1998
	Platelets	Transfusion	Central Illinois Community Blood Bank 1134 South Seventh Street Springfield, IL 62703 License 1263	12/17/1998
1049	LYMErix Lyme Disease Vaccine (Recombinant OspA)	Active immunization against Lyme disease in individuals aged 15-70 years	SmithKline Beecham Biologicals Rue de l'Institut 89 B-1330 Rixensart BELGIUM License 1090	12/21/1998
	Whole Blood	Transfusion	Gateway Community Blood Program, Inc. 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264	12/24/1998
	Red Blood Cells	Transfusion	Gateway Community Blood Program, Inc. 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264	12/24/1998
	Plasma	Transfusion	Gateway Community Blood Program, Inc. 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264	12/24/1998
	Platelets	Transfusion	Gateway Community Blood Program, Inc. 1800 Craigshire Drive St. Louis, MO 63146-4006 License 1264	12/24/1998
	Thymoglobulin Anti-thymocyte Globulin (Rabbit)	Treatment of acute rejection in renal transplant patients	Pasteur Meriex Serums et Vaccins, S.A. 58 Avenue Leclerc 69007 Lyon, FRANCE License 0384	12/30/1998
●CBER - 1997 Biological License Application Approvals
ML	Tradename/ Proper Name	Indication for Use	Manufacturer/ License No.	Approval Date
	Source Plasma	For further manufacture	Nations Biologics,Inc. 1900 Lafayette St. Gretna, LA 70053 License 1221	01/17/1997
	Diphtheria &Tetanus Toxoids Adsorbed Combined Bulk (For Further Manufacturing Use)	For further manufacture under shared arrangement with SmithKline Beecham Biologicals	Chiron Behring GmbH & Co. P.O. Box 1630 35006 Marburg GERMANY License 1222	01/29/1997
	Infanrix Diphtheria &Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed	For primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses	SmithKline Beecham Biologicals, S.A. 89, Rue de l'Institut 1330 Rixensart BELGIUM License 1090	01/29/1997
	Red Blood Cells	Transfusion	Am-Rho Labs., Inc. 780 Park North Boulevard, #110 Clarkston, GA License 0991	02/10/1997
	Benefix Coagulation Factor IX (Recombinant)	Control and Prevention of hemorrhagic episodes in patients with hemophilia B, including the perioperative management of hemophilia B patients undergoing surgery	Genetics Institute,Inc. 1 Burtt Road Andover, MA License 1163	02/11/1997
	Cryoprecipitated AHF	Transfusion	Spartanburg Blood Bank, Inc. 175 Dunbar Street Spartanburg, SC License 0765	02/18/1997
	Source Plasma	For further manufacture	Joliet Blood Plasma, L.L.C. 502 N. Capitol Ave. Indianapolis, IN 46204 License 1223	03/03/1997
	Platelets	Transfusion	South Bend Medical Foundation, Inc. 530 N. Lafayette Blvd. South Bend, IN 46601 License 0248	03/07/1997
	Source Plasma	For further manufacture	SeraCare Acquisitions,Inc. 1925 Century Park East Los Angeles, CA 90067 License 1224	03/19/1997
	Platelets	Transfusion	Arizona Blood Institute, Inc. 3915 E. Broadway Blvd. Tucson, AZ 85711 License 1225	03/20/1997
	Plasma	Transfusion	Arizona Blood Institute, Inc. 3915 E. Broadway Blvd. Tucson, AZ 85711 License 1225	03/20/1997
	Diphtheria & Tetanus Toxoids Adsorbed	Immunization of infants and children, 6 weeks to 7 years of age	Connaught Labs. Ltd. 1755 Steeles Avenue West North York, Ontario, CANADA M2R 3T4 License 0073	04/11/1997
	Source Plasma	For further manufacture	The Canadian Red Cross Society 1800 Alta Vista Drive Ottawa, ON KIG 4J5 CANADA License 1226	05/01/1997
	Whole Blood	Transfusion	United States Blood Bank, Inc. 130 Ponce de Leon Blvd. Coral Gables, FL 33135 License 1229	06/23/1997
	Red Blood Cells	Transfusion	United States Blood Bank, Inc. 130 Ponce de Leon Blvd. Coral Gables, FL 33135 License 1229	06/23/1997
	Plasma	Transfusion	United States Blood Bank, Inc. 130 Ponce de Leon Blvd. Coral Gables, FL 33135 License 1229	06/23/1997
	Source Plasma	For further manufacture	Melrose Plasma, L.L.C. 105 Chapel Drive Lafayette, LA 70506 License 1230	08/07/1997
	Plasma	Transfusion	Serologicals, Inc. 780 Park North Blvd. Clarkston, GA 30021 License 0963	08/07/1997
	Red Blood Cells	Transfusion	Serologicals, Inc. 780 Park North Blvd. Clarkston, GA 30021 License 0963	08/07/1997
	Whole Blood	Transfusion	Serologicals, Inc. 780 Park North Blvd. Clarkston, GA 30021 License 0963	08/07/1997
	Abbott HTLV-I HTLV-III EIA Human T-Lymphotropic Virus Types I and II	EIA for detection of HTLV-I/HTLV-II antibodies in serum or plasma	Abbott Laboratories D-49C, AP6C/2 Abbott Park, Buckley Rd.& Waukegan Road North Chicago, IL 60064 License 0043	08/15/1997
	Carticel SM Service Autologous Cultured Chondrocytes	Repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle	Genzyme Tissue Repair 64 Sidney Street Cambridge, MA 02139 License 1233	08/22/1997
	Source Plasma	For further manufacture	DCI Biologicals 764 Main Street Dunedin, FL License 1234	10/09/1997
1029	RabAvert Rabies Vaccine	Rabies vaccine for immunization of children and adults	Chiron Behring GmbH P.O. Box 1630 35006 Marburg, GERMANY License 1222	10/20/1997
	Source Leukocytes	For further manufacture	Serologicals, Inc. 780 Park North Blvd.,Suite 110 Clarkston, GA 30021 License 0963	12/09/1997
●CBER - 1996 Biological License Application Approvals
	Tradename/ Proper Name	Indication for Use	Manufacturer/ License No.	Approval Date
	Blood Grouping Reagent (Monoclonal)(For Further Manufacturing Use)	Shared manufacturing arrangement with Immucor, Inc.	Sanofi Diagnostics Pasteur, S.A. Parc Hightec 9 Avenue du Canada Batiment LATITUDE-B.P.354 91966 LES ULIS CEDEX FRANCE License 1198	01/03/1996
	Respigam Respiratory Syncytial Virus Immune Globulin Intravenous (Human)	Prevention of serious lower respiratory tract infection in children less than 24 months of age	Massachusetts Public Health Biologic Labs 305 South Street Boston, MA 02130 License 0064	01/18/1996
	Source Plasma	For further manufacture	BioMune Corporation Post Office Box 310701 Boca Raton, FL 33431-0701 License 1200	02/05/1996
	Red Blood Cells	Transfusion	South Bend Medical Foundation, Inc. 530 N. Lafayette Blvd. South Bend, IN 46601 License 0248	03/05/1996
	Plasma	Transfusion	Community Blood Bank of Lancaster County Medical Society 2966 "O" Street Lincoln, NE 68510 License 0695	03/05/1996
	Coulter HIV-1 p24 Antigen Assay Neutralization Kit Antibody to HIV-1 p24 Antigen (Murine Monoclonal)	In-vitro diagnostic test kit used in the detection of HIV Type 1 Antigen	Coulter Corporation MC 31-B06, P.O. Box 169015 Miami, FL 33116-9015 License 1185	03/14/1996
	Plasma	Transfusion	Blood Bank of the Redwoods 2324 Bethards Dr. Santa Rosa, CA 95405-8537 License 0197	3/15/1996
	VAQTA Heptatitis A Vaccine Inactivated	Immunization against hepatitis A in children over 6 years of age	Merck & Co., Inc. Sumneytown Pike West Point, PA 19486 License 0002	03/29/1996
	Reverse-Cyte Reagent Red Blood Cells	In vitro diagnostic test kit	Dade AG Bonnstrasse 9 3186 Dudingen SWITZERLAND License 1138	04/03/1996
	Platelets	Transfusion	Blood Bank of San Bernardino and Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License 0226	04/25/1996
	Source Leukocytes	Transfusion	Florida Georgia Blood Blood Alliance, Inc. 536 West 10th Street Jacksonville, FL 32206 License 0181	05/06/1996
	Source Plasma	For further manufacture	Green Street Biologicals, Inc.105 Chapel Drive Lafayette, LA 70506 License 1203	05/06/1996
	Cryoprecipitated AHF	Transfusion	Central Blood Bank 812 Fifth Avenue Pittsburgh, PA 15219 License 0234	06/26/1996
	Cryoprecipitated AHF	Transfusion	Civitan Regional Blood Center, Inc. 1221 NW 13th Street Gainesville, FL 32601 License 0843	06/26/1996
	Immu-4 Bulk (For Further Manufacturing Use)	Shared manufacturing arrangement with Immunomedics, Inc.	Charles River Div.of Wilmington Partners, L.P. 251 Ballardvale Street Wilmington, MA 01887 License 1206	06/28/1996
	CEA-Scan Arcitumomab	Imaging agent used in the detection of colorectal carcinoma	Immunomedics, Inc. 300 American Road Morris Plains, NJ 07950 License 1205	06/28/1996
	Myoscint Imciromab Pentetate	Cardiac imaging agent for detection of myocardial necrosis	Centocor B.V. 2300 AG Leiden Einsteinweg 101 P.O. Box 251 NETHERLANDS License 1178	07/03/1996
	Plasma	Transfusion	Blood Bank of San Bernardino and Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License No 0226	08/06/1996
	Calypte HIV-1 Urine EIA HIV-Type 1 (Recombinant)	In vitro diagnostic test kit used in the detection of antibodies to HIV-1 present in urine	Calypte Biomedical Corp 1440 Fourth Street, Berkeley, CA 94701 License 1207	08/06/1996
	Antihemophilic Factor (Human)	Treatment of patients with hemophilia A	Centeon Pharma GmbH Post Office Box 1230 D-35002 Marburg GERMANY License 1202	08/22/1996
	Plasma	Transfusion	Am-Rho Laboratories,Inc 780 N. Park Blvd.Suite 100 Clarkston, GA 30021 License 0991	08/22/1996
	Therapeutic Exchange Plasma	Collection of plasma from patients diagnosed with Guillain-Barre and who have developed high titers of IgM antibody to Cytomegalovirus	Community Blood Center of Greater Kansas City 4040 Main Street Kansas City, MO 64111 License 0302	09/03/1996
	Whole Blood	Transfusion	Sitka Community Hosp. 209 Moller Street Sitka, AK 99835 License 1210	09/03/1996
	RSV High Titer Fraction II+III Paste (For Further Manufacturing Use)	Shared manufacturing arrangement with Massachusetts Public Health Biologic Labs	Baxter Heathcare Corp. 305 South Street Boston, MA 02130 License 0140	09/10/1996
	COMVAX Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine	Immunization of persons 6 weeks to 15 months of age born of Hepatitis B Surface Antigen (HBsAg) negative mothers	Merck & Co., Inc. Sumneytown Pike West Point, PA 19486 License No. 0002	10/02/1996
	Cryoprecipitated AHF	Control bleeding associated with Factor VIII deficiency	Blood Bank of the Redwoods 2324 Bethards Drive Santa Rosa, CA 95405-8537 License No. 0197	10/03/1996
	Whole Blood	Transfusion	South East Alaska Regional Health Consortium 222 Tongass Drive Sitka, AK 99835 License No. 1212	10/10/1996
	Whole Blood	Transfusion	Littleton Regional Hospital 107 Cottage Street Littleton, NH 03561 License No. 1213	10/10/1996
	Red Blood Cells	Transfusion	Littleton Regional Hosptial 107 Cottage Street Littleton, NH 03561 License No. 1213	10/10/1996
	Source Plasma	For Further Manufacture	Decatur Plasma, Inc. 105 Chapel Drive Lafayette, LA 70506 License No. 1214	10/21/1996
	Source Plasma	For Further Manufacture	Atopix Pharma.Corporation 5375 Avenida Encinas Suite B Carlsbad, CA 92008 License No. 1215	10/21/1996
	Source Leukocytes	Transfusion	The Blood Center of New Jersey, Inc. 45 South Grove St. East Orange, NJ 07018 License 0221	11/13/1996
	Plasma	Transfusion	Puget Sound Blood Center 921 Terry Avenue Seattle, WA 98104 License 0192	11/21/1996
	Source Plasma	For further manufacture	Clinical Research Technologies 12095 W. Washington Boulevard Los Angeles, CA 90066 License 1217	12/11/1996
	UB1 HIV1/2 EIA Human Immuno-deficiency test to detect Virus Types 1 & 2	In vitro diagnostic antibodies to HIV1/2 in human serum or plasma	United Biomedical, Inc. 25 Davids Drive Hauppauge, NY 11788 License 1079	12/20/1996
	Cryoprecipitated AHF	Transfusion	Blood Bank of San Bernardino and Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License 0226	12/26/1996
	Cryoprecipitated AHF	Transfusion	Blood Bank of San Bernardino and Pooled Riverside Counties 384 Orange Show Road San Bernardino, CA 92412 License 0226	12/26/1996
	Source Plasma	For further manufacture	Cal Plasma Center,L.L.C. 105 Chapel Drive Lafayette, LA 70506 License 1219	12/26/1996
	Cryoprecipitated AHF	Transfusion	Inova Health Care Services 3289 Woodburn Road, Suite 10 Annandale, VA 22003 License 0365	12/26/1996
	Source Plasma	For further manufacture	SeraCare, Inc. 1925 Century Park, East, Suite 1970 Los Angeles, CA 90067 License 1218	12/26/1996

●CBER - 2004 Biological License Application Approvals - Approvals through December
ML	Tradename/ Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
1184	Avastin (bevacizumab) Package Insert	First-line treatment for patients with metastatic colorectal cancer	125085/0	Genentech, Inc. -1 DNA Way MS#48, South San Francisco, CA 95080; Lincense 1048	2/26/2004
1184	Erbitux Cetuximab	Erbitux is a monoclonal antibody that targets a protein called the epidermal growth factor receptor (EGFR).	125084 / 0	ImClone Systems, Incorporated License 1695	2/12/2004

●CBER - 2003 Biological License Application Approvals - Approvals through December
ML	Tradename/ Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
1145	Amevive Alefacept	Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy	125036 / 0	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	1/30/2003
	Avonex Interferon beta-1a	Revised Package Insert: To include safety and efficacy data from a study of patients who experienced a single clinical exacerbation of multiple sclerosis and to provide a Medication Guide	103628 / 5001	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	1/31/2003
	Betaseron Interferon beta-1b	Revised Package Insert: Revised the Clinical Studies section (include data from two studies conducted in patients with secondary progressive multiple sclerosis (MS)), Adverse Reactions and Warnings sections (include new safety information); and provided a Medication Guide	103471 / 1039	Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 License 1106	3/14/2003
	Roferon-A Interferon alfa-2a	Revised labeling: To provide for a Medication Guide	103145 / 5010	Hoffman La-Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	3/14/2003
	Remicade Infliximab	Indication for Use: Reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn痴 disease	103772 / 5032	Centocor, Inc 200 Great Valley Parkway Malvern, PA 10355-1307 License 1242	4/1/2003
1165	Fabrazyme Agalsidase beta	For use in patients with Fabry disease to reduce globotriaosylceramide (GL-3) deposition in capillary endothelium of the kidney and certain other cell types	103979 / 0	Genzyme Corp One Kendall Square Cambridge, MA 02139-1562 License 1596	4/24/2003
1168	Aldurazyme Laronidase	For patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established. Laronidase has been shown to improve pulmonary function and walking capacity. Laronidase has not been evaluated for effects on the central nervous system manifestations of the disorder	125058 / 0	Biomarin Pharmaceutical Inc 371 Bel Marin Keys Boulevard Suite 210 Novato, CA 94949 License 1649	4/30/2003
	Rebif Interferon beta-1a	Revised Package Insert: Final pivotal study report that confirms the results of 48 week data	103780 / 5010	Serono, Inc One Technology Place Rockland, MA 02370 License 1574	5/2/2003
	*Simulect* Basiliximab	For the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids		Novartis Pharmaceutical Corporation 59 Route 10 East Hanover, NJ 07930-1080 License 1244	05/12/1998
	Avonex Interferon beta-1a	Indication for Use: To include an HSA-free liquid formulation in a prefilled syringe as an alternate dosage form	103628 / 5021	Biogen, Inc 14 Cambridge Center Cambridge, MA 02142 License 1204	5/28/2003
	Enbrel Etanercept	Revised Package Insert: Information regarding concurrent Etanercept and Anakinra therapy	103795 / 5109	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	6/5/2003
1163	Xolair Omalizumab	For adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids	103976 / 0	Genentech, Inc 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/20/2003
1168	Bexxar Tositumomab and Iodine I-131 Tositumomab	Treatment of patients with CD20 positive, follicular, non-Hodgkin's lymphoma, with and without transformation, whose disease is refractory to Rituximab and has relapsed following chemotherapy	125011 / 0	Corixa Corp 1124 Columbia Street Suite 200 Seattle, WA 98104 License 1614	6/27/2003
	Kineret Anakinra	Revised Package Insert: Include information on an increased risk of serious infections when used with Etanercept and a revised definition of the threshold for neutropenia	103950 / 5013	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320 License 1080	6/27/2003
	Enbrel Etanercept Letter		103795 / 5123	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
	Enbrel Etanercept Letter	Rheumatoid arthritis indication.	103795 / 5097	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
	Enbrel Etanercept Letter	Revision to Precautions and Adverse Reactions sections of the package insert to include patients with heart failure.	103795 / 5055	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	7/24/2003
	Enbrel Etanercept Letter		103795 / 5102	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	8/21/2003
	Kineret Anakinra Letter		103950 / 5019	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320 License 1080	8/21/2003
	*Remicade* Infliximab Letter	Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet.	103772 / 5056	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	09/03/2003
	*Remicade* Infliximab Letter	Revision of Package Insert to include a contraindication for patients with congestive heart failure, update the Warnings and Adverse Reactions sections, and update the patient information sheet.	103772 / 5020	Centocor, Inc. 200 Great Valley Parkway Malvern, PA 19355 License 1242	09/03/2003
	Interferon alfa-2a	Removal of Kaposi's sarcoma indication.	103145/5026	Hoffman-LaRoche	9/10/2003
	Enbrel Etanercept Letter		103795 / 5099	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	10/9/2003
	Rituxan Rituximab Letter	Revision of Adverse Reactions Section of the package insert.	103737 / 5023	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA License 1235	10/9/2003
	Betaseron Interferon beta-1b Letter Label	Provides for the use of diluent in a prefilled syringe, instead of a vial configuration.	103471 / 5032	Chiron Corp 4560 Horton Street Emeryville, CA 94608-2916 License 1106	10/10/2003
	Herceptin Trastuzumab Letter		103792 / 5046	Genentech, Inc 1 DNA Way South San Francisco, CA 94080 License 1048	10/16/2003
	Enbrel Etanercept Letter		103795 / 5110	Immunex Corp One Amgen Center Drive Mailstop 24-2-C Thousand Oaks, CA 91320 License 1132	10/17/2003
	Raptiva EFALIZUMAB Letter		125075/0	Genentech	10/27/03
	Simulect Basiliximab Letter		103764 / 50340	Novartis Pharmaceutical Corp One Health Plaza East Hanover, NJ 07936-1080 License 1244	11/14/2003
	*ReoPro* Abciximab Letter		103575/5025	Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/21/2003
	*ReoPro* Abciximab Letter		103575/5022	Centocor B.V. Einsteinweg 101, P.O. Box 251 2300 AG Leiden NETHERLANDS License 1178	11/21/2003
●CBER - 2002 Biological License Application Approvals - Approvals through December
ML	Tradename/ Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
1130	Neulasta Pegfilgrastim	To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia	125031/0	Amgen, Incorporated one Amgen Center Drive Thousand Oaks, CA 91320-1799 License 1080	1/31/2002
1144	Zevalin Ibritumomab Tiuxetan	Treatment of patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma, including patients with Rituximab (Rituxan) refractory follicular non-Hodgkin's lymphoma; the therapeutic regimen includes Rituximab, Indium-111 Ibritumomab Tiuxetan, and Yttrium-90 Ibritumomab Tiuxetan	125019/0	IDEC Pharmaceuticals Corp 3030 Callan Road San Diego, CA 92121 License 1235	2/19/2002
1141	Rebif Interferon beta-1a	Treatment of patients with relapsing forms of multiple sclerosis to decrease the frequency of clinical exacerbations and delay the accumulation of physical disability	103780/0	Serono, Inc One Technology Place Rockland, MA 02370 License 1574	3/7/2002
1143	Elitek Rasburicase	Initial management of plasma uric acid levels in pediatric patients with leukemia, lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid	103946/0	Sanofi-Synthelabo, Inc 9 Great Valley Parkway P.O. Box 3026 Malvern, PA 19355 License 1294	7/12/2002
1151	PEGASYS Peginterferon alfa-2a	Treatment of adults with chronic hepatitis C who have compensated liver disease and who have not been previously treated with interferon alfa	103964/0	Hoffman-La Roche, Inc 340 Kingsland Street Nutley, NJ 07110-1199 License 0136	10/16/2002
1153	Humira Adalimumab	For reducing signs and symptoms and inhibiting the progression of structural damage in adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Adalimumab can be used alone or in combination with Methotrexate (MTX) or other DMARDs.	125057/0	Abbott Laboratories 200 Abbott Park Road D-491, AP30�1E Abbott Park, IL 60064-6157 License 0043	12/31/2002
●CBER - 2001 Biological License Application Approvals
ML	Tradename/ Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
1107	PEG-Intron Peginterferon alfa-2b	Treatment of chronic hepatitis C in patients not previously treated with interferon alfa who have compensated liver disease and are at least 18 years of age	103949/0	Schering Corp 2000 Galloping Hill Road Kenilworth, NJ 07033 License 0994	1/19/2001
	Campath Alemtuzumab	Treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy	103948/0	Millennium and ILEX Partners, LP 75 Sidney Street Cambridge, MA 02139 License 1289	5/7/2001
1120	Aranesp Darbepoetin alfa	Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis	103951/0	Amgen, Incorporated One Amgen Center Drive Thousand Oaks, CA 91320-1789 License 1080	9/17/2001
1124	Kineret Anakinra	Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDS)	103950/0	Amgen, Inc One Amgen Center Drive Thousand Oaks, CA 91320-1789 License 1080	11/14/2001
1124	Xigris Drotrecogin alfa (activated)	Reduction of mortality in adult patients with severe sepsis (sepsis associated with acute organ dysfunction) who have a high risk of death (e.g., as determined by APACHE II)	125029/0	Eli Lilly and Co Lilly Corporate Center Indianapolis, IN 46285 License 1611	11/21/2001
●CBER - 2000 Biological License Application Approvals
ML	Tradename/ Proper Name	Indication for Use	STN	Manufacturer/ License No.	Approval Date
1092	TNKase Tenecteplase	Reduction of mortality associated with acute myocardial infarction (AMI)		Genentech, Inc. 1 DNA Way South San Francisco, CA 94080-4990 License 1048	6/02/2000
1109	MYOBLOC Botulinum Toxin Type B	Treatment of cervical dystonia to reduce the severity of abnormal head position and neck pain	103846/0	Elan Pharmaceuticals 800 Gateway Boulevard S. San Francisco, CA 94080 License 1579	12/8/2000