Efavirenz/lamivudine/tenofovir disoproxil fumarate regulatory update

Aurobindo said late last month that FDA granted tentative approval to efavirenz/lamivudine/tenofovir disoproxil fumarate tablets alone or in combination with other antiretrovirals to treat HIV-1 infection. The fixed-dose combination of 600 mg efavirenz, 300 mg lamivudine and 300 mg tenofovir is eligible for purchase outside the U.S. under the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) program. The World Health Organization's June guidance on HIV treatments includes a recommendation to start HIV treatment with a once-daily, fixed-dose oral combination of tenofovir, efavirenz and either lamivudine or emtricitabine. ...