Zydus Cadila gets US FDA approval for generic muscle relaxing injection

The approval is for single-dose vials of Cisatracurium Besylate Injection USP with strengths of 10 mg/5 ml and 200 mg/20 ml

Cadila Healthcare on Tuesday said group firm Zydus Cadila has received final approval from the US health regulator for its generic version of muscle relaxant Cisatracurium Besylate Injection given before general anaesthesia.

The approval by the US Food and Drug Administration is for single dose vials of Cisatracurium Besylate Injection USP with strengths of 10 mg/5 ml and 200 mg/20 ml.

This medication is used to relax the muscles. It works by blocking the signals between nerves and muscles and is given before general anaesthesia in preparing for surgery, the company said in a regulatory filing.

The injection will be manufactured at Liva Pharmaceuticals, a wholly-owned subsidiary of Cadila, it added.

The group now has 275 approvals and has so far filed over 360 abbreviated new drug applications, since the commencement of the filing process in financial year 2003-04, it added.

Shares of Cadila Healthcare were trading at Rs 241.05 apiece, down 0.17 per cent on the BSE.