Product Approval Information This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. Product approval information is arranged alphabetically by the proper name of the product. To locate specific approval information by product tradename, select the Licensing Actions Tradename Table. Transfer of Therapeutic Products to CDER Allergenic Extracts Proper name: Allergenic Extracts Trade name: None Standardized Grass Pollen Extracts: Kentucky Bluegrass, Timothy Grass, Meadow Fescue Grass, Sweet Vernal Grass, Orchard Grass, Redtop Grass, with potencies of 100,000 and 10,000 Bioequivalent Allergy Units Manufacturer: Allergy Laboratories, Inc, Oklahoma City, Oklahoma, License #103 Approval Date: 5/29/1997 Type of submission: Product license supplement Alpha-1-Proteinase Inhibitor (Human) Proper name: Alpha-1-Proteinase Inhibitor (Human) Tradename: Zemaira Manufacturer: Aventis Behring L.L.C., King of Prussia, PA, License #1281 Indication for Use: Chronic augmentation and maintenance therapy in individuals with alpha1-proteinase inhibitor deficiency and evidence of emphysema Approval Date: 7/8/2003 Type of submission: Biologics license application Proper name: Alpha-1-Proteinase Inhibitor (Human) Tradename: Aralast Manufacturer: Alpha Therapeutic Corp, Los Angeles, CA License #0744 Indication for Use: For augmentation therapy in patients having congenital deficiency of alpha-1-proteinase inhibitor with clinically evident emphysema Approval Date: 12/23/2002 Type of submission: Biologics license application Anthrax Vaccine Adsorbed Proper name: Anthrax Vaccine Adsorbed Tradename: Biothrax Manufacturer: BioPort Corp, Lansing, MI, License #1260 Indication for Use: Extension of dating to 24 months Approval Date: 4/29/2004 Type of submission: Biologics license application supplement Proper name: Anthrax Vaccine Adsorbed Tradename: Biothrax Manufacturer: BioPort Corp, Lansing, MI, License #1260 Manufacturing change: Hollister-Stier as contract manufacturer for filling Approval Date: 1/31/2002 Type of submission: Biologics license application supplement Proper name: Anthrax Vaccine Adsorbed Tradename: Biothrax Manufacturer: BioPort Corp, Lansing, MI, License #1260 Labeling change: Update of labeling Approval Date: 1/31/2002 Type of submission: Biologics license application supplement Anti-B (Murine Monoclonal) Proper name: Anti-B (Murine Monoclonal) Tradename: None Manufacturer: Immucor, Inc, Norcross, GA, License #0886 Indication for Use: Use in slide, tube, microplate and ABS2000 tests Approval Date: 9/14/2001 Type of submission: Biologics license application Antibody to Hepatitis B Surface Antigen Proper name: Antibody to Hepatitis B Surface Antigen Tradename: IMx HBsAg Manufacturer: Abbott Laboratories, North Chicago, IL, License #0043 Indication for Use: Confirmatory enzyme immunoassay for the detection of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma Approval Date: 12/4/1995 Type of submission: Product license application supplement Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) Proper name: Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) Tradename: HBsAg EIA 2.0 & HBsAg Confirmatory Assay 2.0 Manufacturer: Genetic Systems Corp, Redmond, WA, License #0978 Modified Indication for Use: Include the testing of cadaveric serum samples Approval Date: 12/28/1999 Type of submission: Product license supplement Antihemophilic Factor (Human) Proper name: Antihemophilic Factor (Human) Tradename: Koate-DVI Manufacturer: Bayer Corp, Berkley, CA, License #0008 Manufacturing Change: Second viral inactivation step in the manufacturing process Approval Date: 5/20/1999 Type of submission: Product license supplement Antihemophilic Factor (Recombinant) Proper name: Antihemophilic Factor (Recombinant) Tradename: Kogenate FS, Helixate FS Manufacturer: Bayer Corp, Berkeley, CA License #0008 Manufacturing Change: New product formulation Approval Date: 6/26/2000 Type of submission: Biologics license application supplement Proper name: Antihemophilic Factor (Recombinant) Tradename: ReFacto Manufacturer: Genetics Institute, Inc, Andover, MA, License #1163 Indication for Use: Control and prevention of hemorrhagic episodes and for short-term routine and surgical prophylaxis in patients with hemophilia A Approval Date: 3/6/2000 Type of submission: Biologics license application Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method Proper name: Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method Tradename: Advate Manufacturer: Baxter Healthcare Corp, Westlake Village, CA, License #0140 Indication for Use: Indicated in hemophilia A (classical hemophilia) for the prevention and control of bleeding episodes, and in the perioperative management of patients with hemophilia A Approval Date: 7/25/2003 Type of submission: Biologics license application Antihemophilic Factor/von Willebrand Factor Complex (Human) Proper name: Antihemophilic Factor/von Willebrand Factor Complex (Human) Tradename: Humate-P Manufacturer: Centeon Pharma G.m.b.H, Marburg, Germany, License #1202 Indication for Use: For use in adult patients for treatment and prevention of bleeding in hemophilia A (classic hemophilia) and 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 Approval Date: 4/1/1999 Type of submission: Product license application Anti-thymocyte Globulin (Rabbit) Proper name: Anti-thymocyte Globulin (Rabbit) Tradename: Thymoglobulin Manufacturer: Pasteur Merieux Serums et Vaccins, S.A, 69007 Lyon, France, License #384 Indication for Use: Treatment of acute rejection in renal transplant patients Approval Date: 12/30/1998 Type of submission: Biologics license application Autologous Cultured Chondrocytes Proper name: Autologous Cultured Chondrocytes Tradename: Carticel Manufacturer: Genzyme Biosurgery, Cambridge, MA, License #1659 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 Approval Date: 2/17/2004 Type of submission: Biologics license application supplement Proper name: Autologous Cultured Chondrocytes Tradename: Carticel SM Service Manufacturer: Genzyme Tissue Repair, Cambridge, MA, License #1233 Indication for Use: To 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 Approval Date: 3/2/2000 Type of submission: Biologics license application supplement Proper name: Autologous Cultured Chondrocytes Tradename: Carticel SM Service Manufacturer: Genzyme Tissue Repair, Cambridge, MA, License #1233 Indication for Use: Repair of clinically significant, symptomatic cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma Approval Date: 8/22/1997 Type of submission: Biologics license application BCG Live Proper name: BCG Live Tradename: PACIS Manufacturer: BioChem Pharma Inc, Sainte-Foy, Quebec, Canada, License #1283 Indication for Use: Treatment of carcinoma-in-situ (CIS) in the absence of associated invasive cancer of the bladder Approval Date: 3/9/2000 Type of submission: Biologics license application Proper name: BCG Live Tradename: TICE BCG Manufacturer: Organon Teknika Corp, Durham, NC License #0956 Indication for Use: Expand the indication for intravesical instillation, to include adjunct treatment of stage Ta or Tl papillary tumors of the bladder Approval Date: 8/21/1998 Type of submission: Biologics license application supplement Blood Grouping Reagent Combination Kit Proper name: Blood Grouping Reagent Combination Kit Tradename: none Manufacturer: Micro Typing Systems, Inc, Pompano Beach, FL, License #1177 Indication for Use: Include the manufacture of a "Monoclonal Rh Phenotype Card" Approval Date: 5/14/2002 Type of submission: Biologics license supplement Botulism Immune Globulin Intravenous (Human) Proper name: Botulism Immune Globulin Intravenous (Human) Tradename: BabyBIG Manufacturer: California Department of Health Services, Durham, NC, License #1622 Indication for Use: Treatment of infant boutlism caused by type A or type B Clostridium botulinum Approval Date: 10/23/2003 Type of submission: Biologics license application Coagulation Factor VIIa (Recombinant) Proper name: Coagulation Factor VIIa (Recombinant) Tradename: NovoSeven Manufacturer: Novo Nordisk A/S, Denmark, License #1261 Indication for Use: For use in the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX Approval Date: 3/25/1999 Type of submission: Biologics license application Coagulation Factor IX (Recombinant) Proper name: Coagulation Factor IX (Recombinant) Tradename: Benefix Manufacturer: Genetics Institute, Inc, Andover, MA License #1163 Indication for Use: For use in the control and prevention of hemorrhagic episodes in patients with hemophilia B, including the peri-operative management of hemophilia B patients undergoing surgery Approval Date: 2/11/1997 Type of submission: Biologics license application Crotalidae Polyvalent Immune Fab (Ovine) Proper name: Crotalidae Polyvalent Immune Fab (Ovine) Tradename: CroFab Manufacturer: Protherics Inc, Nashville, TN, License #1575 Indication for Use: Treatment of minimal and moderate North American Crotalidae envenomation Approval Date: 10/2/2000 Type of submission: Biologics license application Digoxin Immune Fab (Ovine) Proper name: Digoxin Immune Fab (Ovine) Tradename: DigiFab Manufacturer: Protherics Inc, Nashville, TN , License #1545 Indication for Use: Treatment of patients with life-threatening or potentially life-threatening digoxin toxicity or overdose Approval Date: 8/31/2001 Type of submission: Biologics license application Diphtheria and Tetanus Toxoids Adsorbed (DT), for Pediatric Use Proper name: Diphtheria and Tetanus Toxoids Adsorbed (DT), for Pediatric Use Tradename: None Manufacturer: Aventis Pasteur Inc, Swiftwater, PA, License #1277 Indication for Use: To include addition of a preservative-free, single dose vial presentation Approval Date: 1/29/2003 Type of submission: Biologics license application supplement Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: Infanrix Manufacturer: GlaxoSmithKline Biologicals, 1330 Rixensart, Belgium, License #1090 Indication for Use: To include in the indication a fifth dose at 4-6 years of age after 4 prior doses of Infanrix Approval Date: 7/7/2003 Type of submission: Biologics license application supplement Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) Tradename: DAPTACEL Manufacturer: Aventis Pasteur Limited, Toronto, Ontario, License #1280 Indication for Use: Active immunization of infants and toddlers at 2, 4, 6, and 17-20 months of age against diphtheria, tetanus and pertussis Approval Date: 5/14/2002 Type of submission: Biologics license application Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed Tradename: Tripedia Manufacturer: Aventis Pasteur, Inc, Swiftwater, PA License #1277 Indication for Use: Include a preservative-free, single dose vial presentation Approval Date: 3/7/2001 Type of submission: Product license application supplement Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine, Adsorbed Tradename: Tripedia Manufacturer: Aventis Pasteur, Inc, Swiftwater, PA License #1277 Indication for Use: Include a 5th dose at 4-6 years of age after 4 prior doses of Tripedia Approval Date: 8/24/2000 Type of submission: Product license application supplement Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: Certiva Manufacturer: North American Vaccine, Inc, Beltsville, MD, License #1254 Indication for Use: Immunization of infants and children except as a fifth dose in children who have previously received four doses of DTaP Approval Date: 7/29/1998 Type of submission: Biologics license application Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: Infanrix Manufacturer: SmithKline Beecham Biologicals, 1330 Rixensart, Belgium, License #1090 Indication for Use: Primary and booster immunization of infants and children except as a fifth dose in children who have previously received four doses of DTaP Approval Date: 1/29/97 Type of submission: Biologics license application Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: Acel-Imune Manufacturer: Lederle Laboratories Division American Cyanamid Co, Pearl River, New York, License #0017 Indication for Use: New indication for use as a three dose primary series in children at least six weeks of age and for the fourth and fifth dose in children who have received three doses of DTaP or Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed Approval Date: 12/30/1996 Type of submission: Product license supplement Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: Tripedia Manufacturer: Connaught Laboratories, Inc, Swiftwater, PA, License #0711 Indication for Use: For the reconstitution of Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), manufactured by Pasteur Merieux Serums et Vaccins, S.A., for immunization of 15-18 month old children Approval Date: 9/27/1996 Type of submission: Product license supplement Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Tradename: Tripedia Manufacturer: Connaught Laboratories, Inc, Swiftwater, PA, License #0711 Indication for Use: Additional indication as primary series in infants and children Approval Date: 7/31/1996 Type of submission: Product license supplement Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Proper name: Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Tradename: Pediarix Manufacturer: SmithKline Beecham Biologicals, Rixensart, Belgium, License #1090 Indication for Use: 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 Approval Date: 12/13/2002 Type of submission: Biologics license application Fibrin Sealant Proper name: Fibrin Sealant (Human) Tradename: Crosseal Manufacturer: OMRIX biopharmaceuticals, Ltd., BELGIUM, License #1603 Indication for Use: Adjunct to hemostasis in patients undergoing liver surgery, when control of bleeding by conventional surgical techniques is ineffective or impractical Approval Date: 3/21/2003 Type of submission: Biologics license application Proper name: Fibrin Sealant Tradename: TISSEEL VH Kit Manufacturer: Osterreichisches Institut Fur Haemoderivate Ges.m.b.H, A-1220 Vienna Austria, License #258 Indication for Use: 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 conventional surgical techniques, including suture, ligature, and cautery, is ineffective or impractical; also indicated as an adjunct for the closure of colostomies Approval Date: 5/1/1998 Type of submission: Biologics license application Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine Proper name: Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine Tradename: COMVAX Manufacturer: Merck & Co, Inc, West Point, PA, License #0002 Indication for Use: Immunization of persons 6 weeks to 15 months of age born to hepatitis B surface antigen (HBsAg) negative mothers Approval Date: 10/2/1996 Type of submission: Product license application Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Proper name: Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) Tradename: ActHIB Manufacturer: Pasteur Merieux Serums et Vaccins, S.A, Lyon, France, License #0384 Indication for Use: Reconstitution with Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed, manufactured by Connaught Laboratories, Inc, for immunization of 15-18 month old children Approval Date: 9/27/1996 Type of submission: Product license supplement Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine Proper name: Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine Tradename: TWINRIX Manufacturer: SmithKline Beecham Biologicals, Rixensart, Belgium, License #1090 Indication for Use: 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 Approval Date: 5/11/2001 Type of submission: Biologics license application Hepatitis A Vaccine, Inactivated Proper name: Hepatitis A Vaccine, Inactivated Tradename: VAQTA Manufacturer: Merck & Co, Inc, West Point, PA, License #0002 Indication for Use: For the immunization of persons two years of age and older Approval Date: 3/29/1996 Type of submission: Product license application Hepatitis B Immune Globulin (Human) Proper name: Hepatitis B Immune Globulin (Human) Tradename: Nabi-HB Manufacturer: Nabi, Boca, FL, License #1022 Indication for Use: 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 Approval Date: 10/23/2001 Type of submission: Biologics license application Proper name: Hepatitis B Immune Globulin (Human) Tradename: Nabi-HB Manufacturer: Nabi, Boca Raton, FL, License #1022 Indication for Use: For the 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 Approval Date: 3/24/1999 Type of submission: Biologics license application Hepatitis B Vaccine (Recombinant) Proper name: Hepatitis B Vaccine (Recombinant) Tradename: Engerix-B Manufacturer: SmithKline Beecham Biologicals, 1330 Rixensart, Belgium, License #1090 Manufacturing Change: Preservative-free pediatric monodose presentation Approval Date: 3/28/2000 Type of submission: Product license application supplement Proper name: Hepatitis B Vaccine (Recombinant) Tradename: Recombivax Manufacturer: Merck & Co, Inc, West Point, PA, License #0002 Labeling Supplement: To include the 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 Approval Date: 9/23/1999 Type of submission: Product license application supplement Proper name: Hepatitis B Vaccine (Recombinant) Tradename: Recombivax Manufacturer: Merck & Co, Inc, West Point, PA, License #0002 Manufacturing Change: Preservative-free pediatric / adolescent product Approval Date: 8/27/1999 Type of submission: Product license application supplement Proper name: Hepatitis B Vaccine (Recombinant) Tradename: Engerix-B Manufacturer: SmithKline Beecham Biologicals, 1330 Rixensart, Belgium, License #1090 Indication for Use: In individuals (adults) with chronic Hepatitis C infection Approval Date: 7/7/1998 Type of submission: Product license application supplement Hepatitis C Virus Proper name: Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) Tradename: COBAS Ampliscreen HCV Manufacturer: Roche Molecular Systems, Pleasanton, CA, License #1636 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) Approval Date: 5/13/2004 Type of submission: Biologics license application supplement Hepatitis C Virus Assay Proper name: Hepatitis C Virus Assay Tradename: COBAS AmpliScreen HCV Test Manufacturer: Roche Molecular Systems, Inc, Pleasanton, CA, License #1636 Indication for Use: Dectecting HCV RNA, in conjunction with licensed tests for detecting antibodies to HCV Approval Date: 12/3/2002 Type of submission: Biologics license application Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) Proper name: Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) Tradename: CHIRON RIBA HCV 3.0 Strip Immunoblot Manufacturer: Chiron Corp, Emeryville, CA, License #1106 Indication for Use: Strip Immunoblot Assay including NS5 and c33c recombinant proteins and c100p, 5-1-1p and c22p synthetic peptides to detect antibodies to Hepatitis C Virus in human serum or plasma Approval Date: 2/11/1999 Type of submission: Product license application supplement Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay Proper name: Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay Tradename: UltraQual HCV-RT-PCR-Assay Manufacturer: National Genetics Institute, Los Angeles, CA, License #1582 Indication for Use: Qualitative detection of hepatitis C virus (HCV) ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples Approval Date: 9/18/2001 Type of submission: Biologics license application Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic) Proper name: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic) Tradename: Procleix Manufacturer: Gen-Probe, Inc, San Diego, CA, License #1592 Indication for Use: 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 Approval Date: 2/27/2002 Type of submission: Biologics license application Proper name: Human Immunodeficiency Virus Type 1 and/or Hepatitis C Virus (HIV-1 and Hepatitis C Virus/ Nucleic Acid Pooled Testing/Synthetic) Tradename: Procleix Manufacturer: Gen-Probe, Inc, San Diego, CA, License #1592 Expanded indications 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) Approval Date: 6/4/2004 Type of submission: Biologics license application supplement Human Immunodeficiency Virus Type 1 Proper name: Human Immunodeficiency Virus Type 1 (HIV-1/Polymerase Chain Reaction) Tradename: COBAS AmpliScreen HIV-1 Test, version 1.5 Manufacturer: Roche Molecular Systems, Pleasanton, CA, License #1636 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) Approval Date: 12/19/2003 Type of submission: Biologics license application supplement Proper name: Human Immunodeficiency Virus Type 1 Tradename: COBAS AmpliScreen HIV-1 Test Manufacturer: Roche Molecular Systems, Inc, Pleasanton, CA, License #1636 Indication for Use: Qualitative in vitro test for direct detection of HIV-1 RNA in human plasma from donations of whole blood and blood components for transfusion Approval Date: 12/20/2002 Type of submission: Biologics license application Proper name: Human Immunodeficiency Virus Type 1 Tradename: Genetic Systems rLAV Manufacturer: Genetic Systems Corp, Redmond, WA, License #0978 Indication for Use: New HIV-1 enzyme immunoassay (EIA) which contains a combination of HIV-1 viral lysate and HIV-1 recombinant antigen Approval Date: 6/29/1998 Type of submission: Product license supplement Human Immunodeficiency Virus Type 1 (Western Blot) Proper name: Human Immunodeficiency Virus Type 1 (Western Blot) Tradename: Cambridge Biotech HIV-1 (Western Blot) Manufacturer: Cambridge Biotech Corp, Rockville,Maryland, License #1063 Indication for Use: New indication for urine specimen testing Approval Date: 5/28/1998 Type of submission: Product license supplement Human Immunodeficiency Virus Types 1 and 2 (Synthetic Peptide) Proper name: Human Immunodeficiency Virus Types 1 and 2 (Synthetic Peptide) Tradename: Genetic Systems HIV-1 / HIV-2 Peptide EIA Manufacturer: Genetic Systems Corp, Redmond, WA, License #0978 Modified Indication for Use: Include the testing of cadaveric serum samples Approval Date: 2/9/2000 Type of submission: Product license supplement Proper name: Human Immunodeficiency Virus Types 1 and 2 (Synthetic Peptide) Tradename: Genetic Systems HIV-1/HIV-2 Peptide EIA Manufacturer: Genetic Systems Corp, Redmond, WA, License #0978 Indication for Use: Detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 in human serum or plasma Approval Date: 8/22/1997 Type of submission: Product license supplement Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay Proper name: Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay Tradename: UltraQual HIV-1 RT-PCR Manufacturer: National Genetics Institute, Los Angeles, CA, License #1582 Indication for Use: Qualitative detection of human immunodeficiency virus type 1 (HIV-1)on ribonucleic acid (RNA) in pooled human Source Plasma comprised of equal aliquots of not more than 512 individual plasma samples Approval Date: 9/18/2001 Type of submission: Biologics license application Human T-Lymphotropic Virus Types I & II Proper name: Human T-Lymphotropic Virus Types I & II Tradename: Vironostika HTLV-I/II Microelisa System Manufacturer: Organon Teknika Corp, Durham, NC, License #0956 Indication for Use: In vitro qualitative ELISA assay for use in the detection of antibodies to human T-lymphotropic virus types I and/or II in human serum or plasma Approval Date: 1/17/1998 Type of submission: Product license application Proper name: Human T-Lymphotropic Virus Types I & II Tradename: Abbott HTLV-I/HTLV-II EIA Manufacturer: Abbott Laboratories, North Chicago, IL, License #0043 Indication for Use: In vitro qualitative enzyme immunoassay for the detection of antibodies to human T-lymphotropic virus types I and II in human serum or plasma Approval Date: 8/15/1997 Type of submission: Product license application Human T-Lymphotropic Virus Type I p21E Antigen Proper name: Human T-Lymphotropic Virus Type I p21E Antigen Tradename: none Manufacturer: Organon Teknika, B.V, Boxtel, The Netherlands, License #1103 Indication for Use: For further manufacture to Human T-Lymphotropic Virus Types I&II under a shared manufacturing arrangement with Organon Teknika Corp Approval Date: 1/17/1998 Type of submission: Product license application Immune Globulin Intravenous (Human) Proper name: Immune Globulin Intravenous (Human) Tradename: OCTAGAM Manufacturer: OCTAPHARMA Pharmazeutika Produktionsges.m.b.H., Vienna, Austria, License #1646 Indication for Use: Treatment of primary immune deficient diseases Approval Date: 5/21/2004 Type of submission: Biologics license application Proper name: Immune Globulin Intravenous (Human) Tradename: Flebogamma Manufacturer: Instituto Grifols, SA, Barcelona, Spain, License #1181 Indication for Use: Replacement therapy in primary (inherited) humoral immune deficiency disorders Approval Date: 12/15/2003 Type of submission: Biologics license application Immune Globulin Intravenous (Human), 10% by Chromatography Process Proper name: Immune Globulin Intravenous (Human), 10% by Chromatography Process Tradename: Gamunex Manufacturer: Bayer Corp, Berkeley, CA, License #0008 Indication for Use: In primary humoral immunodeficiency and idiopathic thrombocytopenic purpura Approval Date: 8/27/2003 Type of submission: Biologics license application Influenza Virus Vaccine Proper name: Influenza Virus Vaccine Tradename: Fluzone Manufacturer: Aventis Pasteur Inc, Swiftwater, PA, License #1277 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 Approval Date: 9/4/2002 Type of submission: Biologics license application supplement Influenza Virus Vaccine, Live, Intranasal Proper name: Influenza Virus Vaccine, Live, Intranasal Tradename: FluMist Manufacturer: MedImmune Vaccines, Inc, Mountain View, CA, License #1652 Indication for Use: 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 Approval Date: 6/17/2003 Type of submission: Biologics license application Lyme Disease Vaccine (Recombinant OspA) Proper name: Lyme Disease Vaccine (Recombinant OspA) Tradename: LYMErix Manufacturer: SmithKline Beecham Biologicals, B-1330 Rixensart, Belgium, License #1090 Indication for Use: For active immunization against Lyme disease in individuals 15-70 years of age Approval Date: 12/21/1998 Type of submission: Biologics license application Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Proper name: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Tradename: Prevnar Manufacturer: Lederle Laboratories Division American Cyanamid Company, W. Henrietta, NY, License #0017 Indication for Use: Immunization of infants and toddlers against otitis media caused by vaccine serotypes Approval Date: 10/1/2002 Type of submission: Biologics license application supplement Proper name: Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Tradename: Prevnar Manufacturer: Lederle Laboratories Division American Cyanamid Company, W. Henrietta, NY, License #0017 Indication for Use: Immunization of infants 2, 4, 6 and 12-15 months of age to prevent invasive pneumococcal disease Approval Date: 2/17/2000 Type of submission: Biologics license application Pooled Plasma, Solvent Detergent Treated Proper name: Pooled Plasma, Solvent Detergent Treated Tradename: VIPLAS/SD, PLAS+SD Manufacturer: V.I. Technologies, Inc, Melville, NY, License #0386 Indication for Use: 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) Approval Date: 5/6/1998 Type of submission: Biologics license application Rabies Vaccine Proper name: Rabies Vaccine Tradename: RabAvert Manufacturer: Chiron Behring GmbH & Co, Marburg, Germany, License #1222 Indication for Use: Pre-exposure and post-exposure immunization of children and adults Approval Date: 10/20/1997 Type of submission: Product license application Respiratory Syncytial Virus Immune Globulin Intravenous (Human) Proper name: Respiratory Syncytial Virus Immune Globulin Intravenous (Human) Tradename: Respigam Manufacturer: Massachusetts Public Health Biologic Laboratories, Boston, MA, License #0064 Indication for Use: Prevention of serious lower respiratory tract infection caused by Respiratory Syncytial Virus in children less than 24 months of age with bronchopulmonary dysplasia or a history of prematurity (less than or equal to 35 weeks gestation) Approval Date: 1/18/1996 Type of submission: Product license application Rho(D) Immune Globulin Intravenous (Human) Proper name: Rho(D) Immune Globulin Intravenous (Human) Tradename: Rhophylac Manufacturer: ZLB Bioplasma AG, Switzerland, License #1598 Indication for Use: 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 Approval Date: 2/12/2004 Type of submission: Biologics license application Rotavirus Vaccine, Live, Oral, Tetravalent Proper name: Rotavirus Vaccine, Live, Oral, Tetravalent Tradename: RotaShield Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003 Indication for Use: Immunization of infants at 2, 4, and 6 months of age Approval Date: 8/31/1998 Type of submission: Biologics license application Smallpox Vaccine, Dried, Calf Lymph Type Proper name: Smallpox Vaccine, Dried, Calf Lymph Type Tradename: Dryvax Manufacturer: Wyeth Pharmaceuticals, Inc, Pearl River, NY, License #0003 Package Insert Revision: Include a Black Box Warning indicating that acute myopericarditis has been observed after administration of Dryvax to healthy adults Approval Date: 11/5/2004 Type of submission: Biologics license application supplement Proper name: Smallpox Vaccine, Dried, Calf Lymph Type Tradename: Dryvax Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003 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 Approval Date: 6/26/2003 Type of submission: Biologics license application supplement Proper name: Smallpox Vaccine, Dried, Calf Lymph Type Tradename: Dryvax Manufacturer: Wyeth Laboratories, Inc, Marietta, PA, License #0003 Indication for Use: Active immunization against smallpox disease Approval Date: 10/25/2002 Type of submission: Biologics license application supplement Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Proper name: Tetanus and Diphtheria Toxoids Adsorbed For Adult Use Tradename: None Manufacturer: Aventis Pasteur Limited, Durham, NC, License #1622 Indication for Use: Primary and booster immunization of persons 7 - 59 years of age against tetanus and diphtheria Approval Date: 11/3/2003 Type of submission: Biologics license application Tetanus and Diphtheria Toxoids Adsorbed (Td) For Adult Use Proper name: Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use Tradename: DECAVAC Manufacturer: Aventis Pasteur Inc, Swiftwater, PA, License #1277 Indication for Use: Addition of a preservative-free, single dose Luer-Lok syringe presentation Approval Date: 3/24/2004 Type of submission: Biologics license application supplement Tetanus Toxoid Concentrate (For Further Manufacturing Use) Diphtheria Toxoid Concentrate (For Further Manufacturing Use) Proper names: Tetanus Toxoid Concentrate (For Further Manufacturing Use) and                        Diphtheria Toxoid Concentrate (For Further Manufacturing Use) Tradename: None Manufacturer: Statens Seruminstitut, Copenhagen, Denmark, License #1255 Indication for Use: For further manufacture to Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed under a shared manufacturing arrangement with North American Vaccine, Inc Approval Date: 7/29/1998 Type of submission: Biologics license application Varicella Virus Vaccine Live Proper name: Varicella Virus Vaccine Live Tradename: Varivax Manufacturer: Merck & Co, Inc, West Point, PA, License #2 Indication for Use: For the active immunization of persons 12 months of age and older Approval Date: 3/17/1995 Type of submission: Product license application

Updated November 5, 2004

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