The FDA gave Mylan tentative approval under the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) for its HIV combination of dolutegravir, emtricitabine and tenofovir. The antiretroviral will be immediately available in developing countries as a first-line regimen for people being treated for HIV/AIDS.
Mylan’s antiretroviral is a once-daily, fixed-dose combination of dolutegravir, emtricitabine and tenofovir, the individual components that make up ViiV Healthcare’s