Lupin receives USFDA tentative approval for Tenofovir Alafenamide Tablets

Lupin 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.

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

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