Gland Pharma gets U.S. FDA nod for Sugammadex injection
Gland Pharma shares rose after receiving U.S. FDA approval for its Sugammadex injection, a drug used for reversing neuromuscular blockade during surgery. The company has already launched the product in the U.S. market.
Why it matters
FDA approval for generic injectables significantly impacts the company's market position and revenue in the competitive pharmaceutical sector.
Shares of Gland Pharma were in the spotlight on Tuesday, rising more than 4%, after the Hyderabad-based generic injectable drugmaker got the U.S. Food and Drug Administration (FDA) approval for its abbreviated new drug application for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials.
The product is bioequivalent and therapeutically equivalent to Merck Sharp & Dohme’s Bridion Injection. Gland Pharma said it launched the product on the first day through its marketing partner. Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in patients undergoing surgery.
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