Used for the treatment of AIDS, the Hyderabad-based company's fixed-dose combination product contains 150 mg of lamivudine and 300 mg of zidovudine in each tablet, according to latest data available on the USFDA website.
The combination is the first generic version of the already-approved Combivir brand of product manufactured by GlaxoSmithKline.
After the approval, Aurobindo's generic product will now be available for consideration for purchase and use outside the United States under the President's emergency plan for AIDS relief.
The PEPFAR programme provides $15 billion to fight the HIV/AIDS pandemic over a period of five years, with special focus on 15 of the hardest-hit countries.
Lamivudine and Zidovudine are in the class of drugs called nucleoside reverse transcriptase inhibitors, which help prevent the AIDS virus from reproducing.
This fixed-dose combination anti-retroviral drug is intended to be used with other anti-retroviral agents for the treatment of HIV-1 infection.
With this approval, the total number of Aurobindo drugs included under the PEPFAR programme had risen to five.