Lupin gets tentative USFDA nod for HIV drug

Mumbai: Global pharma major Lupin Limited has announced that it has received tentative approval from the United States 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. This 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.. The product is indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg. As per WHO, HIV remains one of the world's most significant public health challenges, particularly in low- and middle-incom