 "Zydus vaccine")
Zydus Lifesciences Ltd on Friday said its US-arm has received tentative approval from the country's health regulator to market its generic version of Sugammadex injection.
The injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery.
The tentative approval granted by the US Food and Drug Administration (USFDA) to Zydus Pharmaceuticals (USA) Inc is for Sugammadex Injection of strengths 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), single-dose vial, the company said in a regulatory filing.
The drug will be manufactured at the group's injectables manufacturing facility at Jarod (Gujarat), India, it added.
Sugammadex Injection had annual sales of USD 772 million in the US, the company said citing IQVIA MAT July 2022.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)
