Zydus Receives Final Approval From The USFDA For Sugammadex Injection

Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as Zydus) 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)), the company on Friday announced through an exchange filing.

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 USD 986 mn 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.

Zydus Lifesciences Limited shares

The shares of Zydus Lifesciences Limited on Friday at 3:30pm IST were at Rs 605, down by 0.0083 percent.