STN: BL 125046
Proper Name: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
Manufacturer: Grifols Therapeutics Inc, License #1871
- For use in primary humoral immunodeficiency, idiopathic thrombocytopenic purpura and chronic inflammatory demyelinating polyneuropathy
Clinical Pharmacology Review - Gamunex-C(PDF - 473KB) Clinical Review - Gamumex-C(PDF - 581KB)
- December 4, 2015 Approval Letter - GAMUNEX®-C/GAMMAKED™ (PDF - 30KB)
Labeling revisions to the package insert for the subcutaneous route of administration in pediatric patients (ages 2 to 16 years) with primary humoral immunodeficiency.
November 9, 2015 Summary Basis for Regulatory Action - Gamunex-C(PDF - 336KB) September 23, 2013 Approval Letter - GAMUNEX®-C/GAMMAKED™
Approval Letters for Safety Labeling Changes
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[ARCHIVED]
Press Release: September 12, 2008