GAMMAGARD LIQUID
STN: BL 125105
Proper Name: Immune Globulin Infusion (Human)
Tradename: GAMMAGARD LIQUID
Manufacturer: Takeda Pharmaceuticals U.S.A., Inc.
Indication:
GAMMAGARD LIQUID is:
- Replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
- Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
- Therapy to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Gammagard Liquid ERC is:
- A replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
Product Information
Supporting Documents
- June 27, 2025 Clinical Review Memo - GAMMAGARD LIQUID
- June 27, 2025 Nonclinical Pharmacology and Toxicology Review - GAMMAGARD LIQUID
- June 27, 2025 Approval Letter - GAMMAGARD LIQUID
- January 26, 2024 Approval Letter - GAMMAGARD LIQUID
- January 26, 2024 Clinical Review Memo - GAMMAGARD LIQUID
- Statistical Review - GAMMAGARD LIQUID
- Preclinical Pharmacology Toxicology Review - GAMMAGARD LIQUID
- Supporting Documents older than three years - Gammagard Liquid