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Vaccines, Blood & Biologics
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Resources for You
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Untitled Letters Regarding Advertising & Promotional Labeling for Approved Biologics
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2009
- Carticel (Autologous Cultured Chondrocytes) Untitled Letter
Genzyme Corporation - 10/8/2009 - Sanitoets HIV Test Kit Untitled Letter
Sallamander Concepts CC (South Africa) - 8/26/2009 - Immune Globulin Intravenous (Human), 10 Percent Caprylate/Chromatography Purified (Gamunex) Untitled Letter
Talecris Biotherapeutics, Inc. - 7/6/2009 - Cytomegalovirus Immune Globulin Intravenous, Human (Cytogam) Untitled Letter
CSL Behring LLC - 7/1/2009 - C1 Esterase Inhibitor (Human)(Cinryze) Untitled Letter
Lev Pharmaceuticals, Inc. - 6/9/2009 - Influenza Virus Vaccine Live, Intranasal (FluMist)
MedImmune Vaccines, Inc. - 2/23/2009
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2008
- Antithrombin III, Human (Thrombate III)
Talecris Biotherapies, Inc. - 9/5/2008 - Anti-Inhibitor Coagulant Complex, Vapor Heated (FEIBA VH)
Baxter Healthcare Corporation - 7/7/2008 - Coagulation Factor IX (Recombinant) (BeneFIX)
Wyeth Pharmaceuticals, Inc - 6/30/2008 - Antihemophilic Factor (Recombinant) (ReFacto)
Wyeth Pharmaceuticals, Inc - 5/23/2008 - Thrombin, Topical (Recombinant) (Recothrom)
ZymoGenetics, Inc - 4/25/2008
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2007
- Haemophilus b Conjugate Vaccine Tetanus Toxoid Conjugate (ActHIB)
Sanofi Pasteur, Inc - 11/21/2007 - Coagulation Factor IX (Human) (Mononine)
CSL Behring LLC - 9/26/2007 - Antibody to Hepatitis B Surface Antigen (Mouse Monoclonal IgM) (ABBOTT PRISM HBsAg); Hepatitis B Virus Core Antigen (E. coli, Recombinant) (ABBOTT PRISM HBcore)
Abbott Laboratories - 2/23/2007 - Crotalidae Polyvalent Immune Fab (Ovine) (CroFab)
Protherics, Inc - 2/6/2007
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2006
- Antihemophilic Factor (Recombinant), ReFacto
Wyeth Pharmaceuticals Inc - 4/13/2006 - Rho(D) Immune Globulin Intravenous (Human), Rhophylac
ZLB Behring LLC - 2/3/2006 - Antihemophilic Factor (Recombinant) Formulated with Sucrose, Kogenate FS
Bayer Healthcare LLC - 1/23/2006
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2004
- Antihemophilic Factor (Recombinant) Formulated with Sucrose (Helixate FS)
Bayer HealthCare LLC - 8/3/2004 - Typhoid Vaccine Live Oral Ty21a (Vivotif)
Berna Biotech Ltd - 6/24/2004 - Typhoid Vi Polysaccharide Vaccine (Typhim Vi)
Aventis Pasteur Inc - 4/2/2004 - Rabies Immune Globulin (Human), Imogam Rabies-HT and Rabies Vaccine, Imovax Rabies
Aventis Pasteur Inc - 2/24/2004 - Antihemophilic Factor (Recombinant), ReFacto
Wyeth Pharmaceuticals Inc - 2/2/2004 - BCG Live (Intravesical), TheraCys
Aventis Pasteur Inc - 1/13/2004
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2003
- Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine, Comvax
Merck & Co, Inc - 12/18/2003 - Rho(D) Immune Globulin Intravenous (Human), WinRho SDF
Cangene Corp - 5/30/2003 - Immune Globulin Intravenous (Human), Gammar-P I.V.
Aventis Behring LLC - 1/23/2003
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Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
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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