USFDA gives nod to Lupin for Desvenlafaxine ER tablets

The product will be manufactured at Lupin’s facility in Goa, India.

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USFDA Approval
USFDA Approval

Last Updated on October 15, 2024 by The Health Master

Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA), desvenlafaxine extended-release tablets, 25 mg to market.

This is a generic equivalent of Pristiq extended-release tablets, 25 mg of PF PRISM C.V. The product will be manufactured at Lupin’s facility in Goa, India.

Desvenlafaxine extended-release tablets, 25 mg (RLD Pristiq) had estimated annual sales of US$ 14 million in the US (IQVIA MAT December 2021)

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