Lupin Receives Tentative Approval from U.S. FDA for Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets

Global pharma major Lupin Limited (Lupin) on 24 September 2025 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.

Additional information to the following link: Lupin Receives U.S. FDA Approval for Risperidone Long-Acting Injectable, with 180-Day CGT Exclusivity, the First Product from its Nanomi’s Long-Acting Injectable Platform