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Zydus Cadila gets USFDA nod for generic drug

The company has received tentative approval from the US Food and Drug Administration to market Pimavanserin tablets in strength of 10 mg, Zydus Cadila said in a statement.

PTI Edited by: PTI
New Delhi Updated on: December 22, 2021 14:31 IST
US Food and Drug Administration, USFDA, Pimavanserin tablets, Zydus Cadila, Zydus Cadila news, Zydus
Image Source : AP/ REPRESENTATIONAL (FILE).

Zydus Cadila gets USFDA nod for generic drug. 

Highlights

  • Drug firm Zydus Cadila on Wednesday said it has received approval from US health regulator
  • Zydus Cadila will now market Pimavanserin tablets used in treatment of certain mental disorders
  • Company has received tentative approval from USFDA to market Pimavanserin tablets

Drug firm Zydus Cadila on Wednesday said it has received approval from the US health regulator to market Pimavanserin tablets, used in the treatment of certain mental disorders, in the American market.

The company has received tentative approval from the US Food and Drug Administration (USFDA) to market Pimavanserin tablets in strength of 10 mg, Zydus Cadila said in a statement.

Pimavanserin is used to treat the symptoms of a certain mental/mood disorder (psychosis) that might occur with Parkinson's disease.

It helps lessen symptoms such as seeing or hearing things that are not there (hallucinations) and false beliefs (delusions).

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

The Zudus 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.

ALSO READ: Bihar, UP among seven states to be administered Zydus Cadila's ZyCoV-D vaccine first

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