Licensed Product Approval Information

The list is arranged alphabetically by the proper name of the product. Information is provided for original product approvals, new indications, and the current package insert.

Complete list of currently licensed products and establishments

Transfer of Therapeutic Products to CDER

Product Trade Name Manufacturer
Albumin (Human) None [Albumin (Human)] Octapharma Pharmazeutika Produktionsgesm.b.H
Allergenic Extracts None [Allergenic Extracts] Allergy Laboratories, Inc
Alpha-1-Proteinase Inhibitor (Human) Aralast NP Baxter Healthcare Corporation
Aralast Baxter Healthcare Corporation
Zemaira Aventis Behring L.L.C.
Anthrax Vaccine Adsorbed Biothrax Emergent BioDefense Operations Lansing Inc.
Anti-B (Murine Monoclonal) None [Anti-B (Murine Monoclonal)] Immucor, Inc
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) Genetic Systems HBsAg EIA 3.0 Abbott Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA) / Monoclonal) Auszyme Monoclonal Abbott Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human) ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg Confirmatory Abbott Laboratories
Antihemophilic Factor (Recombinant) Kogenate FS Bayer Corp
ReFacto Genetics Institute, Inc
Antihemophilic Factor (Recombinant), Plasma/Albumin Free XYNTHA Wyeth Pharmaceuticals, Inc
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method Advate Baxter Healthcare Corp
Antihemophilic Factor/von Willebrand Factor Complex (Human) Humate-P CSL Behring GmbH
Alphanate Grifols Biologicals Inc
Anti-Human Globulin Anti-Human Globulin Solidscreen II Biotest AG
Anti-thymocyte Globulin (Rabbit) Thymoglobulin Genzyme Corp
Autologous Cultured Chondrocytes Carticel Genzyme Biosurgery
BCG Live TICE BCG Organon Teknika Corp
Blood Grouping Reagents ALBAclone Alba Bioscience, Inc
Blood Grouping Reagent Component of Erytype S Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Erytype S Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-Fya (Monoclonal) Seraclone Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-s (Monoclonal) Seraclone Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-S (Monoclonal) Seraclone Biotest Medical Diagnostics GmbH
Blood Grouping Reagents and Anti-Human Globulin reagents Seraclone Biotest Medical Diagnostics GmbH
Blood Grouping Reagent Combination Kit None [Blood Grouping Reagent Combination Kit] Micro Typing Systems, Inc
Botulism Immune Globulin Intravenous (Human) BabyBIG California Department of Health Services
C1 Esterase Inhibitor (Human) Cinryze Lev Pharmaceuticals, Inc.
Coagulation Factor VIIa (Recombinant) NovoSeven
NovoSevenRT
Novo Nordisk, Inc
Coagulation Factor IX (Recombinant) Benefix Wyeth Pharmaceuticals
Crotalidae Polyvalent Immune Fab (Ovine) CroFab Protherics, Inc
Digoxin Immune Fab (Ovine) DigiFab Protherics, Inc
Diphtheria and Tetanus Toxoids Adsorbed None [Diphtheria and Tetanus Toxoids Adsorbed] Sanofi Pasteur, Inc
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed DAPTACEL Sanofi Pasteur, Ltd
Infanrix GlaxoSmithKline Biologicals
Tripedia Sanofi Pasteur, Inc
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined Pediarix GlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine KINRIX GlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel Sanofi Pasteur Limited
Fibrin Sealant TISSEEL Baxter Healthcare Corp
Fibrin Sealant (Human) ARTISS Baxter Healthcare Corp
Evicel Omrix biopharmaceuticals, Ltd
Fibrinogen Concentrate (Human) RiaSTAP CSL Behring GmbH
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine COMVAX Merck & Co, Inc
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB Sanofi Pasteur, SA
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine TWINRIX GlaxoSmithKline Biologicals
Hepatitis A Vaccine, Inactivated Havrix GlaxoSmithKline Biologicals
VAQTA Merck & Co, Inc
Hepatitis B Immune Globulin (Human) Nabi-HB Nabi Biopharmaceuticals
Hepatitis B Immune Globulin Intravenous(Human) HepaGam B Cangene Corp
Hepatitis B Vaccine (Recombinant) Recombivax HB Merck & Co, Inc
ENGERIX-B GlaxoSmithKline Biologicals
Hepatitis B Virus Core Antigen (E.coli, Recombinant) ABBOTT PRISM HBcore Abbott Laboratories
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived) COBAS AmpliScreen HBV Test Roche Molecular Systems, Inc
Hepatitis C Virus Hepatitis C Virus / Polymerase Chain Reaction / Blood Cell Derived) COBAS Ampliscreen HCV Test, version 2.0 Roche Molecular Systems, Inc
Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant) Abbott HCV EIA 2.0 Abbott Laboratories
Hepatitis C Virus Encoded Antigens (Recombinant c100-3, HCr43, NS5) ABBOTT PRISM HCV Abbott Laboratories
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic)(RIBA) CHIRON RIBA HCV 3.0 Strip Immunoblot Assay Novartis Vaccines and Diagnostics, Inc
Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay UltraQual HCV-RT-PCR-Assay National Genetics Institute
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay None [Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay] BioLife Plasma Services, L.P
Human Immunodeficiency Virus Type 1 Genetic Systems rLAV EIA Bio-Rad Laboratories
Human Immunodeficiency Virus Type 1 (HIV-1) HIV-1 (Western Blot) Maxim Biomedical, Inc
Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic) APTIMA HIV-1 RNA Qualitative Assay Gen-Probe, Inc
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 COBAS TaqScreen MPX Test Roche Molecular Systems, Inc.
Human Immunodeficiency Virus Type 1 (HIV-1 / Polymerase Chain Reaction) COBAS AmpliScreen HIV-1 Test, version 1.5 Roche Molecular Systems, Inc
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) Procleix Ultrio Assay Gen-Probe, Inc
Human Immunodeficiency Virus Type 1 and / or Hepatitis C Virus (HIV-1 and Hepatitis C Virus / Nucleic Acid Pooled Testing / Synthetic) Procleix HIV-1/HCV Assay Gen-Probe, Inc
Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay None [Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay] BioLife Plasma Services, L.P.
Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA) / Recombinant) HIVAB HIV-1 / HIV-2 (rDNA) EIA Abbott Laboratories
Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2/Enzyme Immunoassay (EIA)/Recombinant and Synthetic) Genetic Systems HIV-1/HIV-2 Plus O EIA Bio-Rad Laboratories
Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay UltraQual HIV-1 RT-PCR Assay National Genetics Institute
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine GARDASIL Merck & Co., Inc
Human T-Lymphotropic Virus Types I & II Abbott HTLV-I/HTLV-II EIA Abbott Laboratories
ABBOTT PRISM HTLV-I/HTLV-II Abbott Laboratories
Immune Globulin Intravenous (Human) Flebogamma Instituto Grifols, SA
Immune Globulin Intravenous (Human) 5% OCTAGAM OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified Gamunex Talecris Biotherapeutics, Inc
Immune Globulin Intravenous (Human), 10% Liquid Privigen CSL Behring AG
Immune Globulin Intravenous (Human), 10% Solution Gammagard Liquid Baxter HealthCare Corp
Immune Globulin Subcutaneous (Human) Vivaglobin CSL Behring GmbH
Influenza Virus Vaccine Afluria CSL Limited
Fluarix GlaxoSmithKline Biologicals
FluLaval ID Biomedical Corporation of Quebec
Fluvirin Novartis Vaccines and Diagnostics Limited
Fluzone Sanofi Pasteur, Inc
Influenza Virus Vaccine, H5N1 None [Influenza Virus Vaccine, H5N1] Sanofi Pasteur, Inc
Influenza Virus Vaccine, Live, Intranasal FluMist MedImmune Vaccines, Inc
Japanese Encephalitis Virus Vaccine Inactivated JE-Vax Research Foundation for Microbial Diseases of Osaka University
Measles, Mumps, and Rubella Virus Vaccine, Live M-M-R II Merck & Co, Inc
Measles, Mumps, Rubella and Varicella Virus Vaccine Live ProQuad Merck & Co, Inc
Measles Virus Vaccine Live ATTENUVAX Merck & Co, Inc
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra Sanofi Pasteur, Inc
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined Menomune-A/C/Y/W-135 Sanofi Pasteur, Inc
OLYMPUS PK System Blood Grouping and Phenotyping Reagents None [OLYMPUS PK System Blood Grouping and Phenotyping Reagents] DIAGAST
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar Wyeth Pharmaceuticals, Inc
Pneumococcal Vaccine, Polyvalent Pneumovax 23 Merck & Co., Inc
Poliovirus Vaccine Inactivated (Monkey Kidney Cell) IPOL Sanofi Pasteur, SA
Protein C Concentrate (Human) CEPROTIN Baxter Healthcare Corp
Rabies Vaccine IMOVAX Sanofi Pasteur, SA
Rabies Vaccine RabAvert Novartis Vaccines and Diagnostics
Reagent Red Blood Cells None [Reagent Red Blood Cells] Medion Diagnostics AG
Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated Systems Biotestcell and Erytypecell Biotest Medical Diagnostics GmbH
Rho(D) Immune Globulin Intravenous (Human) Rhophylac CSL Behring AG
WinRho SDF Liquid Cangene Corp
Rotavirus Vaccine, Live, Oral ROTARIX GlaxoSmithKline Biologicals
Rotavirus Vaccine, Live, Oral, Pentavalent RotaTeq Merck & Co., Inc
Rubella Virus Vaccine Live MERUVAX II Merck & Co, Inc
Smallpox (Vaccinia) Vaccine, Live ACAM2000 Acambis Inc
Smallpox Vaccine, Dried, Calf Lymph Type Dryvax Wyeth Pharmaceuticals, Inc
Tetanus and Diphtheria Toxoids Adsorbed For Adult Use DECAVAC Sanofi Pasteur, Inc
TENIVAC Sanofi Pasteur, Ltd
Tetanus Toxoid Adsorbed None [Tetanus Toxoid Adsorbed] Sanofi Pasteur, Inc
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Adacel Sanofi Pasteur, Ltd
Boostrix GlaxoSmithKline Biologicals
Thrombin, Topical (Human) Evithrom OMRIX Biopharmaceuticals, Ltd
Thrombin, Topical (Recombinant) RECOTHROM ZymoGenetics, Inc
Trypanosoma cruzi (T. cruzi) Whole Cell Lysate Antigen ORTHO T. cruzi ELISA Test System Ortho-Clinical Diagnostics, Inc
Tuberculin, Purified Protein Derivative Aplisol JHP Pharmaceuticals, LLC
Tuberculin, Purified Protein Derivative Tubersol Sanofi Pasteur, Ltd
Typhoid Vaccine Live Oral Ty21a Vivotif Berna Biotech, Ltd.
Typhoid Vi Polysaccharide Vaccine Typhim Vi Sanofi Pasteur SA
Varicella Virus Vaccine Live Varivax Merck & Co, Inc
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) Procleix West Nile Virus (WNV) Assay Gen-Probe, Inc
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system Roche Molecular Systems, Inc
Yellow Fever Vaccine YF-Vax Sanofi Pasteur, Inc
Zoster Vaccine Zostavax Merck & Co., Inc
 
Updated: January 16, 2009