Sep 18: Drug maker Aurobindo Pharma Ltd on Tuesday announced that it has received approval from the South African Health Products Regulatory Authority (SAHPRA) for its Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets, 50mg/300mg/300mg, the first-line preferred regimen for HIV patients as per latest WHO guidelines.
“Aurobindo is now among the first few companies which has received approval for this product. This approval demonstrates our commitment towards HIV patients and enables the company to participate in South African HIV tender as well as launch in private market. The approval further strengthens Aurobindo’s HIV product basket in South Africa, which has the potential to improve the lives of millions of patients,” the company said in a statement.
Prior to SAHPRA’s approval, Aurobindo has received tentative approval for the drug from US Food and Drug Administration (USFDA) and launched in Sub-Saharan African markets as part of its commitment to bring affordable HIV drugs to millions of patients globally.