Cadila Healthcare's US arm receives FDA nod to market Pimavanserin capsule

Cadila Healthcare on Friday said its US arm Zydus Pharmaceuticals (USA) Inc has received tentative approval from the US health regulator to market generic Pimavanserin capsules, indicated for treatment of hallucinations and delusions associated with Parkinson's disease psychosis. The approval by the US Food & Drug Administration for the generic Pimavanserin capsules is for the strength of 34 mg, Cadila Healthcare said in a regulatory filing.

"The drug will be manufactured at the group's formulation manufacturing facility at SEZ Ahmedabad," it said.

The group now has 325 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of the filing process in FY 2003-04, it added.