June 24, 2024

Zydus Cadila receives tentative approval from USFDA for Pimavanserin Capsules


NEW DELHI: Zydus Cadila’s U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the USFDA to market Pimavanserin Capsules in the strength of 34 mg (USRLD: Nuplazid Capsules).

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. 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.

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