Lupin gets USFDA tentative nod for copy of Merck’s injection

Generic drugmaker Lupin has received U.S. Food and Drug Administration (USFDA) tentative approval for Sugammadex injection.

The USFDA has tentatively approved Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial as bioequivalent to Merck’s Bridion Injection, it said on Tuesday (March 31, 2026).

The drug is indicated for reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery, the company said.