Aurobindo Pharma, a Hyderabad based Indian pharma giant, received tentative approval for its Lamivudine tablets, a generic AIDS drug, from US FDA under the President's Emergency Plan for AIDS Relief. This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR), a US FDA release said.

Lamivudine is in the class of drugs called Nucleoside Reverse Transcriptase Inhibitors (NRTIs), which stop the HIV from infecting uninfected cells in the body. This antiretroviral drug is used in combination with other antiretroviral agents for the treatment of HIV-1 infection. This is the second application for Lamivudine Tablets for which FDA has granted tentative approval.

Murray M Lumpkin, Acting Deputy Commissioner for International and special Programmes said, "This action today is yet another indication of the Department of Health and Human Services' and the FDA's deep commitment to the President's Emergency Plan by helping to ensure that the products offered to patients under this plan are indeed safe, effective, quality medications."

The Emergency Plan for AIDS Relief, which President Bush first announced in his 2003 State of the Union Address, is currently providing $15 billion to fight the HIV/AIDS pandemic over five years, with a special focus on 15 of the hardest hit countries. It targets three specific areas related to HIV/AIDS: Prevention of HIV transmission; Treatment of AIDS and associated conditions; Care, including palliative care for HIV infected-individuals, and care for orphans and vulnerable children.

The agency's tentative approval means that although existing patents and/or exclusivity prevent US marketing of Aurobindo's product, it meets FDA's quality, safety and efficacy standards for US marketing.