Zydus Lifesciences gets USFDA’s final approval for Pimavanserin Capsules, Pimavanserin Tablets

18 Jan 2024 Evaluate

Zydus Lifesciences has received final approvals from the United States Food and Drug Administration (USFDA) to manufacture and market Pimavanserin Capsules, 34 mg (USRLD: Nuplazid Capsules) and Pimavanserin Tablets, 10 mg (USRLD: Nuplazid Tablets), respectively.

Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis. Both the tablets and the capsules will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India. Pimavanserin Capsules, 34 mg had annual sales of $149 million and Pimavanserin Tablets, 10 mg had annual sales of $10 million in the United States (IQVIA Dec. Nov. 2023). 

The group now has 384 approvals and has so far filed over 448 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company. 

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