Gammagard Liquid FDA Approval History
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) 10%) is an immune globulin infusion (human) indicated as replacement therapy in primary humoral immunodeficiency, multifocal motor neuropathy, and chronic inflammatory demyelinating polyneuropathy.
- Gammagard Liquid is indicated as a:
- 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).
Limitations of Use:- 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 for PI is for intravenous or subcutaneous use. Gammagard Liquid for MMN and CIDP is for intravenous use only.
Development timeline for Gammagard Liquid
Further information
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