FDA Approves Mylan's New HIV Combo -TLE400
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
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.

Mylan’s TLE400 is formulated with a 400-mg dose of efavirenz, which is less than the standard dose of 600 mg. The Kirby Institute’s ENCORE1 trial, which used drugs provided by Mylan and Gilead, showed that a reduced dose of 400 mg of efavirenz is noninferior to a dose of 600 mg, when combined with emtricitabine and tenofovir disoproxil fumarate (Truvada, Gilead) during 48 weeks in ARV treatment–naive adults with HIV-1 infection. TLE400 was recommended by the World Health Organization in 2016 as an alternative for first-line therapy for adults living with HIV....

http://www.idse.net/HIVAIDS-STIs/Article/03-17/FDA-Approves-Mylans-New-HIV-Combo/40740
Preview
T●●●●●●●a G●●●●●●r and 3 others like this
Like
Comment
Share