Zydus gets USFDA nod for Sugammadex Injection, 200 mg/2 mL and 500 mg/5 mL single-dose vial

Zydus Lifesciences has received final 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 (USRLD: Bridion Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL)).

Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. The injection will be manufactured at the group’s injectable manufacturing facility at Jarod, near Vadodara, India.

Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), SingleDose Vial had annual sales of $986 million in the United States (IQVIA MAT Aug 2023).

The group now has 381 approvals and has so far filed over 444* ANDAs since the commencement of the filing process in FY 2003-04.