Lupin receives tentative approval from USFDA for Tenofovir Alafenamide Tablets

19 Apr 2022 , 08:26 AM

Global pharma major Lupin Limited has received tentative approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) Tenofovir Alafenamide Tablets, 25 mg, to market a generic equivalent of Vemlidy® Tablets, 25 mg, of Gilead Sciences, Inc. (Gilead).

This product will be manufactured at Lupin’s Nagpur facility in India, the pharma company said.

Tenofovir Alafenamide Tablets (RLD: Vemlidy® Tablets) had estimated annual sales of USD484.2 million in the U.S., as per IQVIA MAT December 2021.