U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

Generic drugmaker Lupin has received tentative support from the U.S. Food and Drug Administration for its abbreviated caller cause exertion for Bictegravir, Emtricitabine and Tenofovir Alafenamide Tablets, 50 mg/200 mg/25 mg.

The tablets are bioequivalent to Gilead Sciences Biktarvy Tablets, 50 mg/200 mg/25 mg and indicated for attraction of quality immunodeficiency microorganism corruption successful adults and pediatric patients weighing astatine slightest 25 kg. Lupin said it would beryllium manufacturing the merchandise astatine its Nagpur facility.

Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (RLD Biktarvy) had estimated yearly income of $16,237 cardinal successful the U.S., the institution said citing IQVIA MAT July 2025 numbers.