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Pharma major Lupin Ltd on Wednesday said it has received tentative approval from the US health regulator for its generic version of Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets used to treat human immunodeficiency virus (HIV) infection.The approval by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application for Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets of strength 50 mg/200 mg/25 mg, Lupin said in a regulatory filing.This product would be manufactured at Lupin’s Nagpur facility, it added.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, it added.Add as a Reliable and Trusted News Source Add Now!
Citing IQVIA MAT July 2025 data, Lupin said the Bictegravir, Emtricitabine, and Tenofovir Alafenamide tablets (Biktarvy) had estimated annual sales of USD 16,237 million in the US.(You can now subscribe to our Economic Times WhatsApp channel)
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(You can now subscribe to our Economic Times WhatsApp channel)Read More News onLupinUSFDAgeneric HIV treatment drugBictegravirTenofovir AlafenamideEmtricitabinePharma majorlupin ltd(Catch all the Business News, Breaking News, Budget 2025 Events and Latest News Updates on The Economic Times.) Subscribe to The Economic Times Prime and read the ET ePaper online….moreless
