Lupin Receives Tentative Approval from U.S. FDA for Sugammadex Injection

Global pharmaceutical leader, Lupin Limited, has received tentative approval from the 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 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.