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Vaccines, Blood & Biologics
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Resources for You
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Licensed Biological Products with Supporting Documents
The list below includes products for which we have supporting documentation. The list is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert.
| Product | Trade Name | Manufacturer |
|---|---|---|
| Albumin (Human) | None [Albumin (Human)] | Octapharma Pharmazeutika Produktionsgesm.b.H |
| Alpha1-Proteinase Inhibitor (Human) |
Baxter Healthcare Corp
Baxter Healthcare Corp
Talecris Biotherapeutics, Inc Aventis Behring LLC |
|
| 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 | Bio-Rad 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) |
Bayer Corp 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) |
|
CSL Behring GmbH Grifols Biologicals, Inc |
| Anti-Human Globulin | Anti-Human Globulin Solidscreen II | Biotest AG |
| Antithrombin (Recombinant) | ATryn | GTC Biotherapeutics, Inc |
| 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 Reagant 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) |
|
NovoNordisk, 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 |
|
Sanofi Pasteur, Ltd
GlaxoSmithKline Biologicals
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, Ltd |
| Fibrin Sealant | TISSEEL | Baxter Healthcare Corp |
| Fibrin Sealant (Human) |
Baxter Healthcare Corp
Baxter Healthcare Corp |
|
| Fibrinogen Concentrate (Human) | RiaSTAP | 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) |
|
GlaxoSmithKline Biologicals, S.A.
Sanofi Pasteur, SA |
| Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine | TWINRIX | GlaxoSmithKline Biologicals |
| Hepatitis A Vaccine, Inactivated |
|
GlaxoSmithKline Biologicals
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) |
|
Merck & Co, Inc
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 Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA), Version 3.0/Recombinant and Synthetic) | Ortho HCV Version 3.0 ELISA Test System |
Ortho-Clinical Diagnostics, Inc. |
| 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-AssayM | 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, LP |
| Human Immunodeficiency Virus Type I | 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) | 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 Laboratories
Abbott Laboratories |
| Immune Globulin Intravenous (Human) |
|
GlaxoSmithKline Biologicals, S.A.,
CSL Behring AG
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 Biotherapies, 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 |
|
CSL Limited
GlaxoSmithKline Biologicals
ID Biomedical Corporation of Quebec
Novartis Vaccines and Diagnostics Limited
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 |
| Japanese Encephalitis Vaccine, Inactivated, Adsorbed | IXIARO | Intercell Biomedical |
| 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, W-135 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 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) |
|
CSL Behring AG
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 |
|
Sanofi Pasteur, Inc
Sanofi Pasteur, Ltd |
| Tetanus Toxoid Adsorbed | None [Tetanus Toxoid Adsorbed] | Sanofi Pasteur, Inc |
| Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
|
Sanofi Pasteur, Ltd
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 |
|
JHP Pharmaceuticals, LLC
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) | cobas TaqScreen West Nile Virus Test for use with the cobas s 201 system | Roche Molecular System, Inc |
| Vaccinia Immune Globulin Intravenous (Human) | None | Cangene Corp. |
| Yellow Fever Vaccine | YF-Vax | Sanofi Pasteur, Inc |
| Zoster Vaccine | Zostavax | Merck & Co, Inc |
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Related Information
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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