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Gland Pharma gets USFDA’s approval for Sugammadex Injection
Jul-29-2026

Gland Pharma has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application filed 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 the reference listed drug (RLD), BRIDION Injection of Merck Sharp & Dohme LLC. The Product is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery. 

According to IQVIA, the product had US sales of approximately $1.6 billion for the twelve months ending April 2026. 

Gland Pharma develops, manufactures and markets complex injectables. The company sells its products primarily under a business-to-business model in many countries. 


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