Zydus’s Sugammadex Injection, 200 mg/2 mL and 500 mg/5 mL single-dose vials, receive USFDA approval

6 Oct 2023 , 06:21 PM

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)) has been given final FDA approval by Zydus Lifesciences.

Sugammadex Injection is recommended for individuals undergoing surgery to reverse the neuromuscular blockade brought on by rocuronium and vecuronium bromide. The group’s injectable manufacturing facility in Jarod, close to Vadodara, India, will produce the injection.

In the United States, sales of Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), SingleDose Vial, totaled $986 million in 2017 (IQVIA MAT Aug 2023).

The group has submitted approximately 444* ANDAs since the filing procedure began in FY 2003–2004, and it now has 381 approvals.

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