FDA Tentatively Approves Viatris's New HIV-I Pediatric Treatment Drug Application

Viatris Inc. has received tentative approval from the US Food and Drug Administration (FDA) for a new drug application targeting pediatric patients with HIV-I infection. The license covers a fixed-dose combination of abacavir 60 mg, dolutegravir 5 mg, and lamivudine 30 mg tablets for oral suspension, which is strawberry-flavoured and designed for children weighing at least six kg. The FDA's tentative approval, under the President's Emergency Plan for AIDS Relief (PEPFAR) program, ensures the formulation meets quality, safety, and efficacy standards.