Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg
Drug Approval

Lupin receives approval from USFDA for Desvenlafaxine extended-release tablets 25 mg

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

  • By IPP Bureau | April 15, 2022

Lupin announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Desvenlafaxine extended-release tablets, 25 mg to market 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 USD 14 million in the U.S. (IQVIA MAT December 2021).

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