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Drug firm Gland Pharma on Friday said it has received a tentative nod from the US health regulator for generic Sugammadex injection, which is indicated for reversing the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to patients during surgery. The company “has received tentative approval from the United States Food and Drug Administration (USFDA) for Sugammadex injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vial…”, Gland Pharma said in a regulatory filing.
The product is the generic version of Merck Sharp & Dohme Corp’s Bridion injection, 100 mg/mL, it added.
The company will launch the product through its marketing partner on receipt of final approval, Gland Pharma said.
According to IQVIA, the Sugammadex injection, 200 mg/2 mL and 500 mg/5 mL single-dose vial had US sales of about USD 615 million for 12 months ended April 2021, it added.
Sugammadex injection is used to reverse the effects of the muscle relaxants rocuronium bromide and vecuronium bromide given to patients during surgery, the filing said.
Shares of Gland Pharma Ltd on Friday closed at Rs 3,851.55 per scrip on the BSE, down 0.82 per cent from its previous close.