FDA grants tentative approval to Lupin for Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets

FDA grants tentative approval to Lupin for Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets

Lupin Limited, a leading global pharmaceutical company, has received tentative approval for its New Drug Application (NDA) for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets from the US Food and Drug Administration (US FDA). The approval, granted under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR), gives Lupin the green light to manufacture the product […]

Lupin Limited gets FDA tentative approval for HIV drug cocktail TLD

Lupin Limited gets FDA tentative approval for HIV drug cocktail TLD

Lupin Limited has been granted tentative approval by the US Food and Drug Administration (FDA) for its new drug application (NDA) for HIV drug cocktail – Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (TLD) Tablets, 50 mg/300 mg/300 mg, and antiretroviral fixed-dose combination (FDC). The TLD product, which has been approved under the US President’s Emergency […]