Zydus Cadila gets US FDA approval for Cisatracurium Besylate Injection

Zydus Cadila has received final approval from the USFDA to market Cisatracurium Besylate Injection USP (US RLD: Nimbex) in the strength of 20 mg (base)/10 mL (2 mg/mL) multiple-dose vial.

Cisatracurium Besylate is a nondepolarising skeletal neuromuscular blocker for intravenous administration. It is an adjunct to general anaesthesia to facilitate tracheal intubation in adults and in paediatric patients one month to 12 years of age and to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU.

The drug will be manufactured at Liva plant of Cadila Healthcare. The group now has 297 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.