Pharma major Lupin Ltd. announced that it has received tentative approval from the US health regulator for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets, used for treating human immunodeficiency virus (HIV) infection.
The US Food and Drug Administration (USFDA) granted approval for the company’s abbreviated new drug application (ANDA) for the 50 mg/200 mg/25 mg strength of the combination tablets, Lupin stated in a regulatory filing.
“This product will be manufactured at Lupin’s Nagpur facility,” the company added.
The tablets are bioequivalent to Biktarvy Tablets, 50 mg/200 mg/25 mg, marketed by Gilead Sciences, Inc., and are indicated for treating HIV infection in adults and pediatric patients weighing at least 25 kg.