Food and Drug Administration - July 11, 2007
Richard Klein & Kimberly Struble

FDA granted tentative approval on July 10, 2007 for a generic formulation of nevirapine tablets, 200 mg, manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. of Zhejiang China, under expedited review provisions developed 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, even though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for consideration for purchase 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 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 is a generic formulation of the already approved Viramune tablets, 200 mg, made by Boehringer Ingelheim, which is protected by existing patent and pediatric exclusivity rights. Effective patent dates are listed in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

Nevirapine is a Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI) indicated for treatment of HIV infection in adults and adolescents in combination with other antiretroviral agents.

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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