By IDSE News Staff
The FDA granted tentative approval under the President’s Emergency Plan for AIDS Relief for Mylan’s dolutegravir, lamivudine and tenofovir disoproxil fumarate tablets, 50 mg/300 mg/300 mg (TDF-3TC-DTG, or TLD).
TLD, an antiretroviral fixed-dose combination, will be available in developing countries as a first-line antiretroviral therapy (ART) for people with HIV/AIDS. Mylan’s TLD combines molecules from three originator medicines: ViiV Healthcare’s