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(06 Oct 2023, 14:57)

Zydus receives USFDA approval for Sugammadex Injection


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 USD 986 mn in the United States (IQVIA MAT Aug 2023).


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