Aurobindo Pharma’s Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets, 50mg/300mg/300mg, which as per latest WHO guidelines is the first-line preferred regimen for HIV patients, has received the approval of the South African Health Products Regulatory Authority (SAHPRA).
Aurobindo is now among the first few companies to have received approval for the product. With the approval, it can participate in South African HIV tender as well as launch the drug in private market, a release from the Hyderabad-based firm on Tuesday said. Prior to SAHPRA’s approval, Aurobindo had received tentative approval for the drug from USFDA and launched the product in Sub-Saharan African markets.
