Pharmaceutical company Mylan N.V. (NASDAQ:MYL) said on Tuesday that it has received tentative approval in the US for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Emtricitabine and Tenofovir Alafenamide Tablets in 50 mg/200 mg/25 mg.

This approval was awarded by the US Food and Drug Administration (FDA) under the US President's Emergency Plan.

Mylan said this is the first tentative approval of Tenofovir Alafenamide and comes just two years after the US FDA approval of Descovy. The combination of these agents is currently included as a "Recommended Initial Regimen for Most People with HIV" in the HIV guidelines of the U S Department of Health and Human Services.

Effective immediately, the antiretroviral (ARV) will be launched in developing countries as a first-line regimen for people being treated for HIV/AIDS.

According to the company, the ARV is a once-daily, fixed-dose combination of Dolutegravir, Emtricitabine and Tenofovir Alafenamide, the individual components that make up ViiV Healthcare's Tivicay and Gilead's Descovy. 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.

The company reportedly manufactures these products under licenses from the Medicines Patent Pool and Gilead Sciences, respectively.