| Tradename |
Proper Name |
Manufacturer |
Approval |
| Abbott HTLV-I / HTLV-II EIA |
Human T-Lymphotropic
Virus Types I & II |
Abbott Laboratories |
8/15/1997 Application |
| Acel-Imune |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Lederle Laboratories Division American Cyanamid Co |
12/30/1996 Supplement |
| ActHIB |
Haemophilus b Conjugate
(Tetanus Toxoid Conjugate) |
Pasteur Merieux Serums et Vaccins, A.S. |
9/27/1996 Supplement |
| Advate |
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method |
Baxter Healthcare Corp |
7/25/2003 Application
|
| Aralast |
Alpha-1-Proteinase Inhibitor (Human) |
Alpha Therapeutic Corp |
12/23/2002 Application |
| BabyBIG |
Botulism Immune Globulin Intravenous (Human) |
California Department of Health Services |
10/23/2003 Application |
| Benefix |
Coagulation Factor IX (Recombinant) |
Genetics Institute, Inc |
2/11/1997 Application |
| Biothrax |
Anthrax Vaccine Adsorbed |
BioPort Corp |
1/31/2002 Supplement 1
1/31/2002 Supplement 2
4/29/2004 Supplement
|
| Cambridge Biotech HIV-1 (Western Blot) |
Human Immunodeficiency Virus Type 1 (Western Blot) |
Cambridge Biotech Corp |
5/28/1998 Supplement |
| Carticel |
Autologous Cultured Chondrocytes |
Genzyme Biosurgery |
2/17/2004 Supplement
|
| Carticel SM Service |
Autologous Cultured Chondrocytes |
Genzyme Tissue Repair |
8/22/1997 Application
3/2/00 Supplement |
| Certiva |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
North American Vaccine, Inc |
7/29/1998 Application |
| Chiron RIBA HCV 3.0 Strip Immunoblot |
Hepatitis C Virus Encoded Antigen (Recombinant / Synthetic)(RIBA) |
Chiron Corp |
2/11/1999 Supplement |
| COBAS AmpliScreen HCV |
Hepatitis C Virus (Hepatitis C Virus/Polymerase Chain Reaction/Blood Cell Derived) |
Roche Molecular Systems, Inc |
5/13/2004 Supplement |
| COBAS AmpliScreen HCV Test |
Hepatitis C Virus Assay |
Roche Molecular Systems, Inc |
12/3/2002 Application |
| COBAS AmpliScreen HIV-1 Test |
Human Immunodeficiency Virus Type 1 |
Roche Molecular Systems, Inc |
12/20/2002 Application
12/19/2003 Supplement |
| Comvax |
Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine |
Merck & Co, Inc |
10/2/1996 Application |
| CroFab |
Crotalidae Polyvalent Immune Fab (Ovine) |
Protherics, Inc |
10/2/2000 Application |
| Crosseal |
Fibrin Sealant (Human) |
OMRIX biopharmaceuticals, Ltd. |
3/21/2003 Application |
| DAPTACEL |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Aventis Pasteur Limited |
5/14/2002 Application
|
|
| DECAVAC |
Tetanus and Diphtheria Toxoids Adsorbed (Td), For Adult Use |
Aventis Pasteur Inc |
3/24/2004 Supplement
|
|
| DigiFab |
Digoxin Immune Fab (Ovine) |
Protherics, Inc |
8/31/2001 Application |
| Dryvax |
Smallpox Vaccine, Dried, Calf Lymph Type |
Wyeth Pharmaceuticals, Inc |
10/25/2002 Supplement
6/26/2003 Supplement
11/5/2004 Supplement |
| Engerix-B |
Hepatitis B Vaccine (Recombinant) |
SmithKline Beecham Biologicals |
7/7/1998 Supplement
3/28/2000 Supplement |
| Flebogamma |
Immune Globulin Intravenous (Human) |
Instituto Grifols, SA |
12/15/2003 Application
|
| FluMist |
Influenza Virus Vaccine, Live, Intranasal |
MedImmune Vaccines, Inc |
6/17/2003 Application
11/2/2004 Supplement |
| Fluzone |
Influenza Virus Vaccine |
Aventis Pasteur Inc |
9/4/2002 Supplement |
| Gamunex |
Immune Globulin Intravenous (Human), 10% by Chromatography Process |
Bayer Corporation |
8/27/2003 Application |
| Genetic Systems rLAV |
Human Immunodeficiency Virus Type 1 |
Genetic Systems Corp |
6/29/1998 Supplement |
| Genetic Systems HIV-1 / HIV-2 Peptide EIA |
Human Immunodeficiency Virus Types 1and 2 (Synthetic Peptide) |
Genetic Systems Corp |
8/22/1997 Supplement
2/9/2000 Supplement |
| HBsAg EIA 2.0 & HBsAg Confirmatory Assay 2.0 |
Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal) Enzyme-Linked Immunosorbent Assay (ELISA) |
Genetic Systems Corp |
12/28/1999 Supplement |
| Helixate FS, Kogenate FS |
Antihemophilic Factor (Recombinant) |
Bayer Corp |
06/26/2000 Supplement |
| Humate-P |
Antihemophilic Factor / von Willebrand Factor Complex (Human) |
Centeon Pharma GmbH |
4/1/1999 Application |
| Imx HbsAg |
Antibody to Hepatitis B Surface Antigen |
Abbott Laboratories |
12/4/1995 Supplement |
| Infanrix |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
SmithKline Beecham Biologicals |
1/29/1997 Application |
| Koate-DVI |
Antihemophilic Factor (Human) |
Bayer Corp |
05/20/1999 Supplement |
| Kogenate FS, Helixate FS |
Antihemophilic Factor (Recombinant) |
Bayer Corp |
06/26/2000 Supplement |
| LYMErix |
Lyme Disease Vaccine (Recombinant OspA) |
SmithKline Beecham Biologicals |
12/21/1998 Application |
| Myoscint |
Imciromab pentetate |
Centocor B.V. |
7/3/1996 Application |
| Nabi-HB |
Hepatitis B Immune Globulin (Human) |
Nabi |
3/24/1999 Application
10/23/2001 Application |
| NovoSeven |
Coagulation Factor VIIa (Recombinant) |
Novo Nordisk A/S |
3/25/1999 Application |
| OCTAGAM |
Immune Globulin Intravenous (Human) |
OCTAPHARMA Pharmazeutika Produktionsges.m.b.H. |
5/21/2004 Application |
| PACIS |
BCG, Live |
BioChem Pharma Inc |
3/9/2000 Application |
| Pediarix |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined |
SmithKline Beecham Biologicals |
12/13/2002 Application |
| Prevnar |
Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) |
Lederle Laboratories Division American Cyanamid Company |
2/17/2000 Application
10/01/2002 Supplement |
| Procleix |
HIV-1 / HCV Assay |
Gen-Probe, Inc |
2/27/2002 Application
6/4/2004 Supplement
|
| RabAvert |
Rabies Vaccine |
Chiron GmbH & Co |
10/20/1997 Application |
| Recombivax |
Hepatitis B Vaccine (Recombinant) |
Merck & Co, Inc |
8/27/1999 Supplement
9/23/1999 Supplement |
| ReFacto |
Antihemophilic Factor (Recombinant) |
Genetics Institute, Inc |
3/6/2000 Application |
| Respigam |
Respiratory Syncytial Virus Immune Globulin Intravenous (Human) |
Massachusetts Public Health Biologic Laboratories |
1/18/1996 Application |
| Rhophylac |
Rho(D) Immune Globulin Intravenous (Human) |
ZLB Bioplasma AG |
2/12/2004 Application |
| RotaShield |
Rotavirus Vaccine, Live, Oral, Tetravalent |
Wyeth laboratories, Inc |
8/31/1998 Application |
| Thymoglobulin |
Anti-thymocyte Globulin (Rabbit) |
Pasteur Merieux Serums et Vaccins, S.A. |
12/30/1998 Application |
| Tisseel VH Kit |
Fibrin Sealant |
Osterreichisches Institut Fur Haemoderivate GmbH |
5/1/1998 Application |
| TICE BCG |
BCG Live |
Organon Teknika Corp |
8/21/1998 Supplement |
| Tripedia |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Connaught Laboratories, Inc |
7/31/1996 Supplement
9/27/1996 Supplement |
| Tripedia |
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed |
Aventis Pasteur, Inc |
8/24/2000 Supplement
3/7/2001 Supplement
|
|
| TWINRIX |
Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine |
SmithKline Beecham Biologicals |
5/11/2001 Application
|
| UltraQualä HCV RT-PCR Assay |
Hepatitis C Virus Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay |
National Genetics Institute |
9/18/2001 Application
|
| UltraQualä HIV-1 RT-PCR Assay |
Human Immunodeficiency Virus Type 1 Reverse Transcriptase Polymerase Chain Reaction (PCR) Assay |
National Genetics Institute |
9/18/2001 Application
|
| VAQTA |
Hepatitis A Vaccine, Inactivated |
Merck & Co, Inc |
3/29/1996 Application |
| Varivax |
Varicella Virus Vaccine Live |
Merck & Co, Inc |
3/17/1995 Application |
| VIPLAS / SD, PLAS+SD |
Pooled Plasma, Solvent Detergent Treated |
V.I. Technologies, Inc |
5/6/1998 Application |
| Vironostika HTLV-I / HTLV-II Microelisa System |
Human T-Lymphotropic Virus Types I & II |
Organon Teknika Corp |
1/17/1998 Application |
| Zemaira |
Alpha-1-Proteinase Inhibitor (Human |
Aventis Behring L.L.C. |
7/8/2003 Application |
