Tentative approval for Lamivudine tablets

The U.S. Food and Drug Administration (FDA) has announced the tentative approval of Lamivudine Tablets manufactured by Aurobindo Pharma LTD. Hyderabad, India. This product will now be available for consideration for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR).

"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,” said Murray M. Lumpkin, M.D., Acting Deputy Commissioner for International and Special Programs.

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.

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.

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