Mumbai, Mar 31 (TNT): Lupin Limited on Tuesday said it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its abbreviated new drug application (ANDA) for Sugammadex Injection.
The approval covers strengths of 200 mg/2 mL and 500 mg/5 mL single-dose vials, the Pharma company said in a release here.
The company said the product has been found bioequivalent to Bridion, marketed by Merck & Co..
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults and paediatric patients aged two years and above undergoing surgery.
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