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 Lupins 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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