By: IPP Bureau
Last updated : April 15, 2022 12:54 pm
The product will be manufactured at Lupin’s facility in Goa, India
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).