FDA gives tentative approval for dolutegravir + emtricitabine + tenofovir alafenamide in HIV/AIDS.- Mylan.
Mylan N.V. announced receipt of tentative approval from the FDA under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for dolutegravir, emtricitabine, and tenofovir alafenamide Tablets, 50 mg/200 mg/25 mg. The antiretroviral (ARV) will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.
The tablet will be the smallest sized single-tablet regimen available for patients in the developing world. It will be offered in a 90-day package as well as a 30-day one, potentially allowing patients fewer trips to the clinics for a refill.
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