Pharmaceutical company Mylan NV (Nasdaq:MYL) (TASE:MYL) reported on Monday that it has received tentative approval from the US Food and Drug Administration for its New Drug Application for Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate Tablets in 50 mg/300 mg/300 mg (TDF-3TC-DTG or TLD) for HIV/AIDS.

The company said TLD, which is an antiretroviral (ARV) fixed-dose combination, will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS under the US President's Emergency Plan for AIDS Relief (PEPFAR).

According to the company, TLD combines molecules from three originator medicines - ViiV Healthcare's Tivicay and Epivir and Gilead Science's Viread.

Last month, the WHO recommended national programmes evaluate using DTG as a first-line therapy based on the medicine's improved tolerability, higher antiretroviral efficacy, lower rates of treatment discontinuation, a higher genetic barrier to resistance and fewer drug interactions than other ARV drugs. Additionally, both the US. Department of Health and Human Services and the European AIDS Clinical Society include DTG as a preferred medicine on their HIV/AIDS treatment guidelines.