Aurobindo Pharma, a Rs. 14,800 crore pharma major, has received tentative approval from US FDA under the US President's Emergency plan for AIDS relief (PEPFAR) for its its new drug application for dolutegravir, lamivudine and tenofovir disoproxil fumarate (TLD tablets, 50mg/300mg/300mg. The triple combination product is expected to be launched in sub-Saharan Africa in Q3FY18.

The approved product is used for the treatment of HIV-1 infection along as a complete regimen in adults and pediatric patients weighing 40 kg and greater. The reference listed drugs of the approved combination product are ViiV Healthacre's tivicay (dolutegrair) and epivir (lamivudine), and Gilead Science's viread (tenofovir disoproxil fumarate).

ViiV Healthcare and Aurobindo Pharma signed a licensing agreement in 2014 that allows Aurobindo Pharma to supply Dollutegravir 50mg in 92 licensed countries, following completion of required local regulatory approval processes.