Lupin Receives Tentative Approval from U.S. FDA for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets

Global pharma major Lupin Limited has announced that it has received tentative approval from the U.S. Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg. The product would be manufactured at Lupin’s Nagpur facility in India. Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg are bioequivalent to Biktarvy® Tablets, 50 mg/200 mg/25 mg of Gilead Sciences, Inc., and indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg. Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets (RLD Biktarvy®) had estimated annual sales of USD 16,237 million in the U.S. (IQVIA MAT July 2025).