Tentative approval of generic abacavir sulfate

The Food and Drug Administration (FDA), on November 6, 2006, granted tentative approval for a generic formulation of abacavir sulfate tablets, 300 mg, manufactured by Cipla Limited of Mumbai, India. The application was reviewed under the expedited review provisions of the President's Emergency Plan for AIDS Relief (PEPFAR).

FDA's tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, the product meets all of the safety, efficacy, and manufacturing quality standards required for marketing in the U.S., and can thus be considered for purchase under PEPFAR.

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval to these applications to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application.

This tentatively approved product, a generic version of Ziagen tablets manufactured by GlaxoSmithKline, is a nucleoside reverse transcriptase inhibitor (NRTI) for use in combination with other antiretroviral agents in the treatment of HIV infection.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration