Zydus Cadila gets FDA approval for Pimavanserin Capsules
Zydus Cadila said that its subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval from the US Food and Drug Administration (FDA) for marketing Pimavanserin Capsules 34 mg.
The reference listed drug (RLD) of Pimavanserin Capsules is Nuplazid Capsules.
According to Zydus Cadila, Pimavanserin is an atypical antipsychotic. It is indicated for treating hallucinations and delusions linked to Parkinson’s disease psychosis.
Zydus Cadila will manufacture Pimavanserin at its formulation manufacturing facility in SEZ Ahmedabad.
The Indian pharma company currently has 325 approvals and has to date filed more than 400 abbreviated new drug applications (ANDAs) since the start of the filing process in FY 2003-04.
Earlier this month, Zydus Pharmaceuticals (USA) had been granted tentative approval from the FDA to commercialize Cariprazine Capsules in the strengths of 1.5 mg, 3 mg, and 4.5 mg, and 6 mg.