Zydus gets USFDA’s nod for antipsychotic drug, stock flat

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

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Zydus Lifesciences was down marginally in the early trade on January 18 after the company received the United States Food and Drug Administration’s approval for a generic antipsychotic drug.

At 9.24 am, Zydus Lifesciences was quoting at Rs 708.80, down Rs 0.90, or 0.13 percent, on the NSE.

“…… has received final approvals from the United States Food and Drug Administration (USFDA) to manufacture and market Pimavanserin Capsules, 34 mg and Pimavanserin Tablets, 10 mg, respectively,” the company said in its release.

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 facility in Ahmedabad.

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

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In December, its wholly-owned subsidiary, Zydus Life, received an intimation under section 143(1) of the IT Act for the assessment year 2023-2024 from the CPC, Income Tax Department, an Income Tax demand of Rs 284.58 crore.

The company also received six observations without any repeats for the API site situated at Changodar, Ahmedabad from FDA.

The company in December 2023 received final approval from the Amreican regulator to manufacture and market Lacosamide Tablets USP, 50 mg, 100 mg, 150 mg, and 200 mg.