Zydus Cadila receives tentative US FDA nod for Pimavanserin capsules

Zydus Cadila’s US subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the FDA to market Pimavanserin Capsules in the strength of 34 mg, the pharma company said on Friday.

Pimavanserin is an atypical antipsychotic and is indicated for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.

The drug will be manufactured at the group’s formulation manufacturing facility at SEZ Ahmedabad, Zydus said in a statement.

The group now has 325 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Shares of Cadila Healthcare Ltd Friday traded 1 per cent higher at Rs 484.10 apiece during late trade.

Zydus Cadila is a global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 23,000 people worldwide.