Product Approval Information
Proper Name: Immune Globulin Intravenous (Human), 10%, Caprylate/Chromatography Purified
Tradename: Gamunex
Manufacturer: Talecris Biotherapeutics, Inc, License #1716
Package Insert (PDF - 318 KB) - Approved: September 12, 2008
Date: September 12, 2008
Additional Indication: Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) to improve neuromuscular disability and impairment and for maintenance therapy to prevent relapse
September 12, 2008 Approval Letter
FDA Approves Treatment for Rare Neurologic Disease - 9/12/2008
Date: August 27, 2003
Indication: Primary humoral immunodeficiency and idiopathic thrombocytopenic purpura
August 27, 2003 Approval Letter