New Delhi, March 31 Pharma major Lupin Ltd announced on Tuesday that it has received tentative approval from the US health regulator for its generic version of Sugammadex injection, used for reversing the effects of muscle relaxants administered during surgery.
The tentative approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Sugammadex Injection in strengths of 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials, Lupin said in a regulatory filing.
The USFDA has tentatively approved Lupin's Sugammadex injection in the specified strengths as bioequivalent to Merck's Bridion injection, it added.
It is used for reversing neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.