Zydus Cadila gets USFDA nod for muscle relaxant injection

PTI, Sep 2, 2020, 3:53 PM IST

Drug firm Zydus Cadila has received final approval from the US health regulator to market Cisatracurium Besylate Injection, a muscle relaxant given before general anesthesia.

Zydus Cadila has received final approval from the US Food and Drug Administration (USFDA) to market Cisatracurium Besylate Injection USP in the strength of 20 mg (base)/10 mL (2 mg/mL) multiple-dose vial, Cadila Healthcare said in a regulatory filing on Wednesday, September 2.

The drug will be manufactured at Liva plant of Cadila Healthcare Ltd. Zydus Cadila is a part of the Cadila Healthcare group.

The group now has 297 approvals and has so far filed over 390 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04.

Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 377.60 apiece on BSE, 0.15 percent lower against their previous close.