STN: BL 125105
Proper Name: Immune Globulin Intravenous (Human), 10% Solution
Tradename: Gammagard Liquid
Manufacturer: Baxter HealthCare Corp, License #0140
- Indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
- Indicated as a maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
September 23, 2013 Approval Letter - GAMMAGARD LIQUID
Approval Letters for Safety Labeling Changes
June 15, 2012 Summary Basis for Regulatory Action(PDF - 275KB) June 22, 2012 Approval Letter - Gammagard Liquid[ARCHIVED]
For maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN)
July 20, 2011 Summary Basis for Regulatory Action - Gammagard Liquid(PDF - 164KB) July 22, 2011 Approval Letter - Gammagard Liquid
To supplement biologics license application for Immune Globulin Infusion (Human) [GAMMAGARD LIQUID], for the treatment of primary immunodeficiency disorders (PID) associated with defects in humoral immunity by subcutaneous route of administration.
Clinical Review Memorandum: BLA STN 125105/708, Baxter’s Immune Globulin Infusion (Human) 10%, 10, 25, 50, 100, 200 and 300 mL Solutions for Subcutaneous Administration(PDF - 371KB) [ARCHIVED] Statistical Review and Evaluation - Gammagard(PDF - 89KB) [ARCHIVED] April 27, 2005 Approval Letter - Gammagard Liquid[ARCHIVED] Summary Basis of Approval - Gammagard Liquid(PDF - 55KB)
- FDA Online Label Repository
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