Zydus receives tentative approval from the US FDA for Sugammadex Injection

Zydus Lifesciences has received tentative approval from the US Food and Drug Administration (FDA) to market Sugammadex injection USP 200 mg/2 mL (100mg/mL) and 500 mg/5 mL (100 mg/mL), single-dose vial, according to a company statement.

Sugammadex is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. The drug will be manufactured at the group’s injectables manufacturing facility at Jarod, India, the statement added.