Lupin Secures Tentative U.S. FDA Approval for Sugammadex Injection
Filing Summary
Lupin Limited has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Sugammadex Injection. The approval covers 200 mg/2 mL and 500 mg/5 mL single-dose vials, deemed bioequivalent to Merck’s Bridion® Injection. This approval pertains to the reversal of neuromuscular blockade in adults and pediatric patients aged 2 years and older undergoing surgery. Lupin is a global pharmaceutical company with a strong presence in multiple therapy areas, including respiratory and cardiovascular.
Lupin Limited announced that it has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for Sugammadex Injection. The approval is for 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials. This approval indicates that Lupin’s product is bioequivalent to Merck’s Bridion® Injection.
The Sugammadex Injection is intended for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide. It is applicable for use in adults and pediatric patients aged 2 years and older who are undergoing surgery. This tentative approval is a significant step in Lupin’s efforts to expand its portfolio in the U.S. market.
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India. The company distributes its products in over 100 markets worldwide. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. The company holds a strong position in India and the U.S. across multiple therapy areas, such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health.
Lupin operates 15 manufacturing sites and 7 research centers globally, supported by a workforce of over 22,000 professionals. The company is committed to improving patient health outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.