India, July 29 -- Gland Pharma Ltd has received approval from the US Food and Drug Administration (USFDA) for its generic Sugammadex Injection, used to reverse the effects of certain muscle relaxants administered during surgical procedures.
The approval covers the company's Abbreviated New Drug Application (ANDA) for Sugammadex Injection in 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial strengths.
The company stated that the product is bioequivalent and therapeutically equivalent to BRIDION Injection of Merck Sharp & Dohme LLC, enabling it to market the generic version in the United States.
Published by HT Digital Content Services with permission from Dion Global Solutions Limited....