Gland Pharma gets USFDA’s tentative approval for Sugammadex Injection

09 Oct 2021 Evaluate

Gland Pharma has received tentative approval from the United States Food and Drug Administration (USFDA) for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial, bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Bridion Injection, 100 mg/mL, of Merck Sharp & Dohme Corp. (Merck Sharp & Dohme).

Sugammadex Injection is used to reverse the effects of the muscle relaxants Rocuronium Bromide and Vecuronium Bromide given to patients during surgery. The company will launch the product through its marketing partner on receipt of final approval. The Sugammadex Injection, 200 mg/2 mL and 500 mg/5 mL Single-Dose Vial (RLD: Bridion) has US sales of approximately $615 million for twelve months ending in April 2021, according to IQVIA.

Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in over 60 countries, including the US, Canada, Australia and India.

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