FDA gives tentative approval to new generic AIDS drug

May 18 2006

The Food and Drug Administration (FDA) today announced the tentative approval of generic abacavir sulfate tablets manufactured by Aurobindo Pharma LTD. of Hyderabad, India.

Abacavir sulfate tablets are the first generic version of the already approved Ziagen Tablets, an anti-HIV medication manufactured by GlaxoSmithKline.

This product will now be available for consideration for purchase under the President's Emergency Plan for AIDS Relief.

"FDA's action adds yet another anti-HIV product to those available for purchase under the President's Plan and demonstrates our continuing commitment to ensuring that safe, effective, and quality manufactured medications are available for purchase under the President's Plan," said Murray M. Lumpkin, M.D., Deputy Commissioner for International and Special Programs.

The President's 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. The President's plan is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children. 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.

Abacavir is one of the non-nucleoside reverse transcriptase inhibitors (NRTIs), a class of drugs that helps keep the AIDS virus from reproducing. It is used in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The agency's tentative approval of this product means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards. Although existing patents and/or exclusivity prevent its marketing in the United States, the product can be marketed abroad and used under the PEPFAR plan.

More information on HIV and AIDS is available online at FDA's website:http://www.fda.gov/oashi/aids/hiv.html