Lupin Ltd. has received tentative approval from the US Food and Drug Administration (USFDA) for its Sugammadex Injection, according to an exchange filing on Tuesday, March 31.
The approval pertains to Lupin’s Abbreviated New Drug Application (ANDA) for Sugammadex Injection in strengths of 200 mg/2 mL and 500 mg/5 mL single-dose vials.
The company said the product has been approved as bioequivalent to Breedswhich is used for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and paediatric patients aged two years and above undergoing surgery.
Sugammadex is indicated to help reverse the effects of certain muscle relaxants administered during surgical procedures.
Lupin said the tentative approval from the USFDA allows it to market the drug in the United States upon receiving final approval and after the expiry of any applicable regulatory exclusivities.
Lupin is a global pharmaceutical company headquartered in Mumbai, with a presence across more than 100 markets and a portfolio spanning branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients.
The company also received approval from the European Commission for its biosimilar ranibizumab, Ranluspec (for vials and pre-filled syringes) in February this year.
Shares of the company closed almost 1% lower at ₹2,312 on Monday, ahead of the announcement. The stock has gained nearly 21% over the past six months.
