- Under the President's Emergency Plan for AIDS Relief ((PEPFAR)), the FDA grants tentative approval of Mylan's (MYL +0.2%) Efavirenz, Lamivudine and Tenofovir Disproxil Fumarate Tablets, 400 mg/300 mg/300 mg, abbreviated as TLE40, for the first-line treatment of HIV-1 infection.
- The 400 mg dose of efavirenz is less than than 600 mg dose in Bristol-Myers Squibb's SUSTIVA. A study showed that the lower dose was non-inferior to the higher dose, when combined with tenofovir and emtricitabine, in antiretroviral therapy-naive adult patients the HIV-1 infection.