Vaccines, Blood & Biologics
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Gammagard Liquid
Proper Name: Immune Globulin Intravenous (Human), 10% Solution
Tradename: Gammagard Liquid
Manufacturer: Baxter HealthCare Corp, License #0140
Indication:
- 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).
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Supporting Documents
June 15, 2012 Summary Basis for Regulatory Action (PDF - 275KB)June 22, 2012 Approval Letter - Gammagard Liquid
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)Statistical Review and Evaluation - Gammagard (PDF - 89KB)April 27, 2005 Approval Letter - Gammagard Liquid Summary Basis of Approval - Gammagard Liquid (PDF - 55KB)
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Related Information
- FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
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