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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of generic abacavir tablets

The Food and Drug Administration (FDA) granted, on May 18, 2006, tentative approval for a generic version of abacavir sulfate tablets, 300 mg, 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. Tentative approval makes this product available for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR).

Abacavir is a nucleoside reverse transcriptase inhibitor (NRTI), 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 means that Aurobindo's product meets all of FDA's manufacturing quality and clinical safety and efficacy standards, but existing patents and/or exclusivity prevent its marketing in the United States at this time.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration