Vaccines, Blood & Biologics
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Gamunex-C
Proper Name: Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Tradename: Gamunex-C
Manufacturer: Talecris Biotherapeutics, Inc, License #1716
Indication: For use in primary humoral immunodeficiency and idiopathic thrombocytopenic purpura.
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Supporting Information
October 13, 2010 Approval Letter - Gamunex-C
New route of administration, subcutaneous administration, for the treatment of Primary Humoral Immunodeficiency.September 12, 2008 Approval Letter - Gamunex-C
Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse.August 27, 2003 Approval Letter
Indication: Primary humoral immunodeficiency and idiopathic thrombocytopenic purpura.FDA Approves Treatment for Rare Neurologic Disease
Press Release: September 12, 2008
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Contact FDA
(800) 835-4709
(301) 827-1800
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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