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)	Aralast NP	Baxter Healthcare Corporation
	Aralast	Baxter Healthcare Corporation
	Prolastin	Talecris Biotherapeutics, Inc.
	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	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)	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   Alphanate	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)	Berinert	CSL Behring GmbH
	Cinryze	Lev Pharmaceuticals, Inc
Coagulation Factor VIIa (Recombinant)	NovoSeven	NovoNordisk, Inc
	NovoSevenRT	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	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, Ltd
Fibrin Sealant	TISSEEL	Baxter Healthcare Corp
Fibrin Sealant (Human)	ARTISS	Baxter Healthcare Corp
	Evicel	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)	Hiberix	GlaxoSmithKline Biologicals, S.A.
	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 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
	Avioq HIV-1 Microelisa System	Avioq, 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 (HPV)(Types 6, 11, 16, 18) Recombinant Vaccine	GARDASIL	Merck & Co, Inc
Human Papillomavirus (HPV) (Types 16 and 18)	Cervarix	GlaxoSmithKline Biologicals, UK
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)	Carimune® NF, Nanofiltered	CSL Behring AG
	Flebogamma	Instituto Grifols, SA
	Gammaplex	Bio Products Laboratory
	Hiberix	GlaxoSmithKline Biologicals, S.A.
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 A (H1N1) 2009 Monovalent Vaccine	None [Influenza A (H1N1) 2009 Monovalent Vaccine]	CSL Limited   MedImmune LLC   Novartis Vaccines and Diagnostics Limited   Sanofi Pasteur, Inc.
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
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)	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   TENIVAC	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	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
	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)	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