Mumbai: Global pharmaceutical leader, Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) Single-Dose Vial.
The U.S. FDA has tentatively approved Lupin’s 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 for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery.
