The approval from the US Meals and Drug Administration (USFDA) is for the abbreviated new drug software (ANDA) filed for Sugammadex Injection in strengths of 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL) single-dose vials, Gland Pharma stated in a regulatory submitting.
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The product is bioequivalent and therapeutically equal to the reference listed drug, BRIDION injection of Merck Sharp & Dohme LLC ZZ it added.
It’s indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in grownup and pediatric sufferers present process surgical procedure, Gland Pharma stated.
Citing IQVIA, the corporate stated the product had US gross sales of roughly USD 1.6 billion for the 12 months ended April 2026.
