Food and Drug Administration - May 16, 2008
Richard Klein & Kimberly Struble

On May 15, 2008, FDA granted tentative approval for a generic formulation of nevirapine tablets, 200 mg, manufactured by Matrix Laboratories Limited, 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 patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase outside the United States under the PEPFAR program.

This tentative approval is a generic version of Viramune Tablets, 200 mg, a Nonnucleoside Reverse Transcriptase Inhibitor (NNRTI), which is a product of Boehringer Ingelheim Pharmaceuticals Inc. Viramune is subject to existing patent protection. Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

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.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan (PEPFAR) is available on the FDA website.

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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