Gammagard Liquid FDA Approval History
Last updated by Judith Stewart, BPharm on July 2, 2025.
FDA Approved: Yes (First approved April 27, 2005)
Brand name: Gammagard Liquid
Generic name: immune globulin infusion (human)
Dosage form: Solution
Company: Takeda Pharmaceutical Company Limited
Treatment for: Primary Immunodeficiency Syndrome, Multifocal Motor Neuropathy, Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Gammagard Liquid (immune globulin infusion (human)) is an immune globulin therapy for use in the treatment of primary humoral immunodeficiency, multifocal motor neuropathy, and chronic inflammatory demyelinating polyneuropathy.
Gammagard Liquid FDA Approval: April 27, 2005
- Gammagard Liquid is a solution containing 10% IgG (100 mg/mL) for intravenous (IV) and subcutaneous (SC) administration.
- Gammagard Liquid contains IgA at an average concentration of 37 μg/mL. Patients with antibodies to IgA have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
- Gammagard Liquid is indicated as a:
- Replacement therapy (IV or SC) for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age or older.
- Maintenance therapy (IV) to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).
- Therapy (IV) to improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Safety and effectiveness of Gammagard Liquid has not been studied in immunoglobulin-naïve patients with CIDP.
Gammagard Liquid maintenance therapy in CIDP has not been studied beyond 6 months.
Gammagard Liquid ERC FDA Approval: June 27, 2025
- Gammagard Liquid ERC is a solution containing 10% IgG (100 mg/mL) for intravenous (IV) and subcutaneous (SC) administration.
- Gammagard Liquid ERC contains IgA at a concentration of less than or equal to 2 µg/mL. Enhanced Removal Capability (ERC) is a step in the manufacturing process to improve IgA reduction. Gammagard Liquid ERC is not indicated specifically for IgA sensitivity in people with PI, but it may be a more appropriate option for them based on their physician’s clinical judgment.
- Gammagard Liquid ERC is indicated as a:
- Replacement therapy (IV or SC) for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.
Development timeline for Gammagard Liquid
Further information
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