Zydus Lifesciences gets tentative FDA approval for Sugammadex generic

Zydus Lifesciences (previously Cadila Healthcare) said that its American subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval for Sugammadex Injection USP 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vial from the US Food and Drug Administration (FDA).

The product is a generic of Bridion (Sugammadex) of Merck. It has approval for use for the reversal of neuromuscular blockade triggered by rocuronium bromide and vecuronium bromide in adults going through surgery.

Zydus Lifesciences gets tentative FDA approval for Sugammadex generic. Photo courtesy of Zydus Cadila.

As per IQVIA MAT July 2022, the annual sales of Sugammadex Injection in the US were $772 million.

Zydus Lifesciences said that it will manufacture the Sugammadex generic drug at its injectables manufacturing plant in Jarod, India.