Aurobindo Pharma Limited has achieved a significant milestone by securing the US Food and Drug Administration (FDA)’s tentative nod under the PEPFAR program for its generic dispersible tablet, a fixed-dose combination of Abacavir 60mg, Lamivudine 30 mg, and Dolutegravir 5 mg (pALD). This formulation is pivotal for treating children afflicted with HIV, particularly those weighing […]
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 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 […]
Dovato EMA approval : The European Commission (EC) has approved ViiV Healthcare’s once-daily, single-pill, two-drug regimen Dovato (dolutegravir/lamivudine) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. Dovato EMA approval The European approval for Dovato is for adults and adolescents aged over 12 years, weighing more than 40 kg, with no known or […]