Vaccines, Blood & Biologics

Licensed Biological Products with Supporting Documents

 | A | B | C | DFH | I | JMO | PR | S | TV | WY | Z |

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.

A   
ProductTrade NameManufacturer
AlbuminAlbumin (Human) (None)Octapharma Pharmazeutika Produktionsgesm.b.H
Kedbumin Kedrion Biopharmaceuticals, SpA
Alpha1-Proteinase Inhibitor (Human)Aralast NPBaxter Healthcare Corporation
AralastBaxter Healthcare Corporation
GLASSIAKamada Ltd.
ProlastinTalecris Biotherapeutics, Inc.
Prolastin-CTalecris Biotherapeutics, Inc.
ZemairaAventis Behring L.L.C.
Anthrax Vaccine AdsorbedBiothraxEmergent 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 3.0Bio-Rad Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme Immuno Assay (EIA)/Monoclonal)Auszyme MonoclonalAbbott Laboratories
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM); Antibody to Hepatitis B Surface Antigen (Human)ABBOTT PRISM HBsAg; ABBOTT PRISM HBsAg ConfirmatoryAbbott Laboratories
Antihemophilic Factor (Recombinant)Kogenate FSBayer Corp
ReFactoGenetics Institute, Inc
RecombinateBaxter Healthcare Corporation
NovoeightNovo Nordisk
Antihemophilic Factor (Recombinant), Plasma/Albumin FreeXYNTHAWyeth Pharmaceuticals, Inc
Antihemophilic Factor (Recombinant), Plasma/Albumin Free MethodAdvateBaxter Healthcare Corp
Antihemophilic Factor/von Willebrand Factor Complex (Human)

Humate-P

 

Alphanate

CSL Behring GmbH

Grifols Biologicals, Inc

Anti-Human GlobulinAnti-Human Globulin Solidscreen IIBiotest AG
Anti-Inhibitor Coagulant ComplexFEIBA NF
 
Baxter Healthcare Corp
Antithrombin (Recombinant)ATrynGTC Biotherapeutics, Inc
Anti-thymocyte Globulin (Rabbit)ThymoglobulinGenzyme Corp
Autologous Cellular ImmunotherapyPROVENGE®Dendreon Corporation
Autologous Cultured ChondrocytesCarticelGenzyme Biosurgery
Azficel-TLAVIVFibrocell Technologies, Inc.
(Return to A - Z List)
B
ProductTrade NameManufacturer
BCG LiveTICE BCGOrganon Teknika Corp
BCG VaccineOrganon Teknika Corp
TheraCysSanofi Pasteur Limited Lic#1726
Blood Grouping ReagentsALBAcloneAlba Bioscience, Inc
Blood Grouping ReagentComponent of Erytype SBiotest Medical Diagnostics GmbH
Blood Grouping ReagentErytype SBiotest Medical Diagnostics GmbH
Blood Grouping Reagents (ALBAsera)Anti-Fya ALBAsera®
Alba Bioscience Limited
Anti-Fyb ALBAsera®
Alba Bioscience Limited
Anti-Wra ALBAsera®
Alba Bioscience Limited
Anti-s ALBAsera®
Alba Bioscience Limited
Anti-K ALBAsera®
Alba Bioscience Limited
Blood Grouping Reagant Anti-Fya (Monoclonal)SeracloneBiotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-s (Monoclonal)SeracloneBiotest Medical Diagnostics GmbH
Blood Grouping Reagent Anti-S (Monoclonal)SeracloneBiotest Medical Diagnostics GmbH
Blood Grouping Reagents and Anti-Human Globulin ReagentsSeracloneBiotest Medical Diagnostics GmbH
Blood Grouping Reagent Combination KitNone [Blood Grouping Reagent Combination Kit]Micro Typing Systems, Inc
Botulism Immune Globulin Intravenous (Human)BabyBIGCalifornia Department of Health Services
Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)None [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) - (Equine)]Cangene Corporation
(Return to A - Z List)
C
ProductTrade NameManufacturer
C1 Esterase Inhibitor (Human)
 
BerinertCSL Behring GmbH
CinryzeLev Pharmaceuticals, Inc
C1 Esterase Inhibitor
(Recombinant)
RUCONESTSalix Pharmaceuticals, Inc.
Coagulation Factor VIIa (Recombinant)NovoSevenNovoNordisk, Inc
NovoSevenRTNovoNordisk, Inc
Coagulation Factor IX (Recombinant)ALPROLIXBiogen Idec, Inc.
Coagulation Factor IX (Recombinant)BenefixWyeth Pharmaceuticals
Coagulation Factor IX (Recombinant)RIXUBISBaxter Healthcare Corporation
Coagulation Factor XIII A-Subunit (Recombinant)TRETTENNovo Nordisk, Inc
Coagulation Factor XIII Concentrate (Human)CorifactCSL Behring, GmbH
(Return to A - Z List)
D
ProductTrade NameManufacturer
Diphtheria and Tetanus Toxoids Adsorbed, STN 103919None [Diphtheria and Tetanus Toxoids Adsorbed]Sanofi Pasteur, Inc
Diphtheria and Tetanus Toxoids Adsorbed, STN 103944None [Diphtheria and Tetanus Toxoids Adsorbed]Sanofi Pasteur, Inc.
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine AdsorbedDAPTACELSanofi Pasteur, Ltd
InfanrixGlaxoSmithKline Biologicals
TripediaSanofi Pasteur, Inc
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine CombinedPediarixGlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus VaccineKINRIXGlaxoSmithKline Biologicals
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) VaccinePentacelSanofi Pasteur, Ltd
(Return to A - Z List)
F
ProductTrade NameManufacturer
Factor IX ComplexProfilnine® SDGrifols Biologicals Inc.
Factor XIII Concentrate (Human)CorifactCSL Behring. GmbH
Fibrin Sealants TopicalTISSEELBaxter Healthcare Corp
ARTISSBaxter Healthcare Corp
EvicelOmrix Biopharmaceuticals, Ltd
Fibrin Sealant Patch, AbsorbableEVARRESTEthicon, Inc
TachoSilNycomed Danmark ApS
Fibrinogen Concentrate (Human)RiaSTAPRiaSTAP (CSL Behring GmbH)
(Return to A - Z List)
H
ProductTrade NameManufacturer
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) VaccineCOMVAXMerck & Co, Inc
Haemophilus B Conjugate Vaccine (Meningococcal Protein Conjugate)PedvaxHIB
 
Merck Sharp & Dohme Corp.
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)HiberixGlaxoSmithKline Biologicals, S.A.
ActHIBSanofi Pasteur, SA
Hepatitis A Inactivated and Hepatitis B (Recombinant) VaccineTWINRIXGlaxoSmithKline Biologicals
Hepatitis A Vaccine, InactivatedHavrixGlaxoSmithKline Biologicals
VAQTAMerck Co, Inc
Hepatitis B Immune Globulin (Human)Nabi-HBNabi Biopharmaceuticals
Hepatitis B Immune Globulin Intravenous (Human)HepaGam BCangene Corp
Hepatitis B Vaccine (Recombinant)Recombivax HBMerck Co, Inc
ENGERIX-BGlaxoSmithKline Biologicals
Hepatitis B Virus Core Antigen (E.coli, Recombinant)ABBOTT PRISM HBcoreAbbott Laboratories
Hepatitis B Virus (Hepatitis B Virus/Polymerase Chain Reaction/Blood Cell Derived)COBAS AmpliScreen HBV TestRoche Molecular Systems, Inc
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived)COBAS AmpliScreen HCV Test, version 2.0Roche Molecular Systems, Inc
Hepatitis C Virus Encoded Antigen (HCV Encoded Antigen/Enzyme Immuno Assay (EIA)/Recombinant)ABBOTT HCV EIA 2.0Abbott 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 HCVAbbott Laboratories
Hepatitis C Virus Encoded Antigen (Recombinant/Synthetic) (RIBA)CHIRON RIBA HCV 3.0 Strip Immunoblot AssayNovartis Vaccines and Diagnostics, Inc
Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) AssayUltraQual HCV-RT-PCR-AssayNational Genetics Institute
Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assayNone [Hepatitis C Virus (HCV) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assay]BioLife Plasma Services, LP
HPC, Cord BloodALLOCORDSSM Cardinal Glennon Children's Medical Center
HPC, Cord BloodDucordDuke University School of Medicine, Carolinas
HPC, Cord BloodHemacordNew York Blood Center, Inc
HPC, Cord BloodNone [HPC, Cord Blood]Clinimmune Labs, University of Colorado Cord Blood Bank
 
HPC, Cord BloodNone [HPC, Cord Blood]LifeSouth Community Blood Centers, Inc.
Human Immunodeficiency Virus Type IGenetic Systems rLAV EIABio-Rad Laboratories
Human Immunodeficiency Virus Type 1 (HIV-1)HIV-1 (Western Blot)Maxim Biomedical, Inc
Avioq HIV-1 Microelisa SystemAvioq, Inc.
Human Immunodeficiency Virus Type 1 (HIV-1 Nucleic Acid Testing/Synthetic)APTIMA HIV-1 RNA Qualitative AssayGen-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 AssayCOBAS TaqScreen MPX TestRoche 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 Hepatitis B Virus/Nucleic Acid Pooled Testing/Synthetic)
 
Procleix Ultrio AssayGen-Probe, Inc
Procleix Ultrio Plus AssaysGen-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 AssayGen-Probe, Inc
Human Immunodeficiency Virus, Type 1 (HIV-1) Reverse Transcription (RT) Polymerase Chain Reaction (PCR) assayNone [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 (E. coli, B. megaterium, Recombinant) Antigen and Synthetic Peptide (ChLIA)ABBOTT PRISM HIV O PlusAbbott Park, IL 
Human Immunodeficiency Virus Types 1 and 2/Enzyme Immuno Assay (EIA) / Recombinant)HIVAB HIV-1/HIV-2 (rDNA) EIAAbbott 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 EIABio-Rad Laboratories
Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) AssayUltraQual HIV-1 RT-PCR AssayNational Genetics Institute
Human Papillomavirus (HPV)(Types 6, 11, 16, 18) Recombinant VaccineGARDASILMerck & Co, Inc
Human Papillomavirus (HPV) (Types 16 and 18)CervarixGlaxoSmithKline Biologicals, UK
Human T-Lymphotropic Virus Types I & II Enzyme Immuno Assay (EIA)/LysateAvioq HTLV - I/II Microelisa SystemAvioq, Inc.
Human T-Lymphotropic Virus Types I & IIAbbott HTLV-I/HTLV-II EIAAbbott Laboratories
ABBOTT PRISM HTLV-I/HTLV-IIAbbott Laboratories
(Return to A - Z List)
I
ProductTrade NameManufacturer
Immune Globulin Intravenous (Human)Carimune® NF, NanofilteredCSL Behring AG
FlebogammaInstituto Grifols, SA
GammaplexBio Products Laboratory
Immune Globulin Intravenous (Human) 5%OCTAGAMOCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography PurifiedGamunex-CTalecris Biotherapies, Inc
Immune Globulin Intravenous (Human), 10% Liquid
 
BivigamBiotest Pharmaceuticals Corporation
PrivigenCSL Behring AG
Immune Globulin Intravenous (Human), 10% SolutionGammagard LiquidBaxter Healthcare Corp
Immune Globulin Subcutaneous (Human)HizentraCSL Behring AG
VivaglobinCSL Behring GmbH
Immune Globulin Products (Animal-derived)CroFabProtherics, Inc
AnascorpRare Disease Therapeutics, Inc.
DigiFabProtherics Inc
Influenza A (H1N1) 2009 Monovalent VaccineNone [Influenza A (H1N1) 2009 Monovalent Vaccine]

CSL Limited

ID Biomedical Corporation of Quebec

MedImmune LLC

Novartis Vaccines and Diagnostics Limited

Sanofi Pasteur, Inc.
 

Influenza VaccineFlublokProtein Sciences Corporation
 
Influenza Virus VaccineAfluriaCSL Limited
AgrifluNovartis Vaccines and Diagnostics, Inc.
FluarixGlaxoSmithKline Biologicals
Fluarix QuadrivalentGlaxoSmithKline Biologicals
FlucelvaxNovartis Vaccines and Diagnostics, Inc.
 
FluLavalID Biomedical Corporation of Quebec
FluLaval QuadrivalentID Biomedical Corporation of Quebec
FluvirinNovartis Vaccines and Diagnostics Limited
Fluzone, Fluzone High-Dose and Fluzone IntradermalSanofi Pasteur, Inc
Fluzone QuadrivalentSanofi Pasteur, Inc.
Influenza Virus Vaccine, H5N1 (for National Stockpile)
 
None [Influenza Virus Vaccine, H5N1]Sanofi Pasteur, Inc
Influenza A (H5N1) Virus Monovalent Vaccine, AdjuvantedID Biomedical Corporation of Quebec
Influenza Virus Vaccine, Live, IntranasalFluMistMedImmune Vaccines, Inc
FluMist® QuadrivalentMedImmune LLC
(Return to A - Z List)
J
ProductTrade NameManufacturer
Japanese Encephalitis Virus Vaccine InactivatedJE-VaxResearch Foundation for Microbial Diseases of Osaka University
Japanese Encephalitis Vaccine, Inactivated, AdsorbedIXIAROIntercell Biomedical
(Return to A - Z List)
M
ProductTrade NameManufacturer
Measles, Mumps and Rubella Virus Vaccine, LiveM-M-R IIMerck & Co, Inc
Measles, Mumps, Rubella and Varicella Virus Vaccine LiveProQuadMerck & Co, Inc
Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate VaccineMenveoNovartis Vaccines and Diagnostics, Inc.
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate VaccineMenactraSanofi Pasteur, Inc
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate VaccineMenHibrixGlaxoSmithKline Biologicals
Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 CombinedMenomune-A/C/Y/W-135Sanofi Pasteur, Inc
(Return to A - Z List)
O
ProductTrade NameManufacturer
OLYMPUS PK System Blood Grouping and Phenotyping ReagentsNone [OLYMPUS PK System Blood Grouping and Phenotyping Reagents]DIAGAST
(Return to A - Z List)
P
ProductTrade NameManufacturer
Pneumococcal Vaccine, PolyvalentPneumovax 23Merck & Co, Inc
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein)PrevnarWyeth Pharmaceuticals, Inc
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)Prevnar 13Wyeth Pharmaceuticals, Inc
Poliovirus Vaccine Inactivated (Monkey Kidney Cell)IPOLSanofi Pasteur, SA
Pooled Plasma (Human), Solvent/Detergent TreatedOctaplasOctapharma Pharmazeutika Produktionsges.m.b.H.
Protein C Concentrate (Human)CEPROTINBaxter Healthcare Corp
Prothrombin Complex Concentrate (Human)KcentraCSL Behring GmbH
(Return to A - Z List)
R   
ProductTrade NameManufacturer
Rabies VaccineIMOVAXSanofi Pasteur, SA
Rabies VaccineRabAvertNovartis Vaccines and Diagnostics
Reagent Red Blood CellsALBAcyteAlba Bioscience Limited 
None [Reagent Red Blood Cells]Medion Diagnostics AG
Reagent Red Blood Cells; Reagent Red Blood Cells For Use in Automated SystemsBiotestcell and ErytypecellBiotest Medical Diagnostics GmbH
Rho(D) Immune Globulin Intravenous (Human)RhophylacCSL Behring AG
WinRho SDF LiquidCangene Corp
Rotavirus Vaccine, Live, OralROTARIXGlaxoSmithKline Biologicals
Rotavirus Vaccine, Live, Oral, PentavalentRotaTeqMerck & Co, Inc
(Return to A - Z List)
S
ProductTrade NameManufacturer
Short Ragweed Pollen Allergen ExtractRAGWITEKMerck Sharp & Dohme Corp
Smallpox (Vaccinia) Vaccine, LiveACAM2000Sanofi Pasteur Biologics Co.
Coccidioides immitis Spherule - Derived Skin Test Antigen
 
SpherusolAllermed Laboratories, Inc.
(Return to A - Z List)
T
ProductTrade NameManufacturer
Tetanus and Diphteria Toxoids AbsorbedNone [Tetanus and Diphteria Toxoids Absorbed]MassBiologics
Tetanus and Diphtheria Toxoids Adsorbed for Adult Use

DECAVAC

 

TENIVAC

Sanofi Pasteur, Inc

 

Sanofi Pasteur, Ltd

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, AdsorbedAdacelSanofi Pasteur, Ltd
BoostrixGlaxoSmithKline Biologicals
Thin-Layer Rapid Use Epicutaneous Patch TestT.R.U.E. TESTMekos Laboratories AS
Thrombin, Topical (Human)EvithromOMRIX Biopharmaceuticals, Ltd
Thrombin, Topical (Recombinant)RECOTHROMZymoGenetics, Inc
Thrombin, Topical (Bovine Origin)THROMBIN-JMIDistributed by: King Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: GenTrac, Incorporated, Middleton, Wisconsin 53562
Trypanosoma cruzi (T. cruzi) (Anti-T. cruzi Assay)Abbott Prism ChagasAbbott Laboratories
Trypanosoma cruzi (T.cruzi) Whole Cell Lysate AntigenORTHO T.cruzi ELISA Test SystemOrtho-Clinical Diagnostics, Inc
Trypanosoma Cruzi (T. cruzi) (E. Coli, Recombinant)ABBOTT ESA ChagasAbbott Laboratories
Tuberculin, Purified Protein DerivativeAplisolJHP Pharmaceuticals, LLC
TubersolSanofi Pasteur, Ltd
Typhoid Vaccine Live Oral Ty21aVivotifBerna Biotech, Ltd
Typhoid Vi Polysaccharide VaccineTyphim ViSanofi Pasteur, SA
(Return to A - Z List)
V
ProductTrade NameManufacturer
Vaccinia Immune Globulin Intravenous (Human)NoneCangene Corp.
Varicella Virus Vaccine LiveVarivaxMerck & Co, Inc
Varicella Zoster Immune Globulin (Human)VARIZIGCangene Corporation
(Return to A - Z List)
W
ProductTrade NameManufacturer
von Willebrand Factor/Coagulation Factor VIII Complex (Human)Wilate®Octapharma Pharmazeutika Produktionsges.m.b.H.
West Nile Virus (WNV) RNAcobas TaqScreen West Nile Virus Test for use with the cobas s 201 systemRoche Molecular System, Inc
West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic)
 
Procleix West Nile Virus (WNV) AssayGen-Probe, Inc
(Return to A - Z List)
Y
ProductTrade NameManufacturer
Yellow Fever VaccineYF-VaxSanofi Pasteur, Inc
(Return to A - Z List)
Z
ProductTrade NameManufacturer
Zoster VaccineZostavaxMerck & Co, Inc
(Return to A - Z List)

 

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(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002

Page Last Updated: 09/12/2014
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