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

Posted on September 24, 2025 By admin
U.S. FDA nod for Lupin’s copy of Gilead Sciences’ HIV drug  

Generic drugmaker Lupin has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application 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 treatment of human immunodeficiency virus infection in…

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