Food and Drug Administration - March 31, 2009
Richard Klein & Kimberly Struble

On March 30, 2009, FDA granted tentative approval for abacavir sulfate and lamivudine tablets, 600 mg / 300 mg, manufactured by Matrix Laboratories Limited of Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).

"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for consideration for purchase outside the United States under the PEPFAR program.

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

This tentative approval is for a generic version of Epzicom tablets, a Nucleoside Reverse Transcriptase Inhibitor (NRTI), made by GlaxoSmithKline.

The FDA web site provides a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan.

Richard Klein

Office of Special Health Issues

Food and Drug Administration

Kimberly Struble

Division of Antiviral Drug Products

Food and Drug Administration

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SOURCE: Food and Drug Administration (FDA).

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