Food and Drug Administration - August 13, 2007
Richard Klein & Kimberly Struble

FDA, on August 13, 2007, granted tentative approval for a generic formulation of nevirapine tablets, 200 mg, manufactured by Hetero Drugs Limited, Hyderabad, India, 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 on-site inspections of each manufacturing facility and of the facilities performing the bioequivalence studies prior to granting approval or tentative approval 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 FDA approved Viramune Tablets, 200 mg, made by Boehringer Ingelheim Pharmaceuticals, Inc., which is subject to existing patent and pediatric exclusivity protections.

Effective patent dates and additional marketing exclusivities can be found 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 Inhibitor (NNRTI) indicated for used 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

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SOURCE: Food and Drug Administration (FDA).

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