Aurobindo Pharma Limited has received tentative approval from the US FDA under the US President's Emergency Plan for AIDS Relief (PEPFAR) for its New Drug Application for Dolutegravir, Lamivudine, and Tenofovir Disoproxil Fumarate (TLD) tablets, 50 mg/300 mg/300 mg.
The approved product is used for the treatment of HIV-1 infection alone 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 Healthcare's Tivicay (Dolutegravir) 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 Dolutegravir 50 mg in 92 licensed countries, following completion of required local regulatory approval processes. The triple combination product is expected to be launched in sub-Saharan Africa in Q3FY18.