The US Food and Drug Administration (FDA) has granted tentative approval to United States-based Mylan for its fixed-dose HIV combination therapy Dolutegravir/Emtricitabine/Tenofovir Alafenamide (DTG/FTC/TAF 50mg/200mg/25mg) tablets, it was reported yesterday.

The product's approval for New Drug Application was granted under the US President's Emergency Plan for AIDS Relief.

Following the approval, the company stated that it will immediately introduce the antiretroviral therapy in developing countries as a first-line regimen for patients being treated for HIV/AIDS. The approved antiretroviral is indicated to be taken daily once as per the fixed dosage. It integrates Dolutegravir, and Emtricitabine and Tenofovir Alafenamide, which in turn are the individual drugs that constitute ViiV Healthcare's Tivicay and Gilead Sciences' Descovy, respectively.