PASATRU Solution for injection Ref.[116899] Active ingredients: Garetosmab

Source: FDA, National Drug Code (US)  Revision Year: 2026 

Product description

Garetosmab-grts is an activin signaling inhibitor. Garetosmab-grts is a human IgG4 monoclonal antibody produced by recombinant DNA technology in Chinese hamster ovary cell suspension culture. Garetosmab-grts has an approximate molecular weight of 146 kDa.

PASATRU (garetosmab-grts) injection is a sterile, preservative-free solution for intravenous use. The solution is clear to slightly opalescent, colorless to pale yellow with a pH of 6.3.

Each PASATRU 300 mg/5 mL vial contains 300 mg of garetosmab-grts. Each mL contains 60 mg of garetosmab-grts, arginine hydrochloride (14.7 mg), histidine (1 mg), L-histidine hydrochloride monohydrate (0.7 mg), polysorbate 20 (0.5 mg), sucrose (50 mg), and Water for Injection, USP.

Dosage Forms and Strengths

Injection: 300 mg/5 mL (60 mg/mL) clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial.

How Supplied

PASATRU (garetosmab-grts) injection is a clear to slightly opalescent, colorless to pale yellow solution. It is supplied in a carton containing one single-dose vial of:

  • 300 mg/5 mL (60 mg/mL) (NDC 61755-012-01)

Manufactured by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707

Drugs

Drug Countries
PASATRU United States

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