By IDSE News Staff
The FDA gave tentative approval to Mylan’s combination tablet, containing efavirenz, lamivudine and tenofovir disoproxil fumarate, 400/300/300 mg (TLE400) for the treatment of HIV infection.
TLE400, an antiretroviral fixed-dose combination approved under the U.S. President’s Emergency Plan for AIDS Relief, will be available in developing countries as a first-line regimen for people being treated for HIV/AIDS.