Food and Drug Administration - December 21, 2007

On December 20, 2007, FDA granted tentative approval for a generic formulation of efavirenz tablets, 600 mg, manufactured by Emcure Pharmaceuticals of Pune, India The application was reviewed under the expedited review provisions of the PresidentÆs Emergency Plan for AIDS Relief (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.

However, although tentatively approved generic products meet required standards, they cannot yet be fully approved and sold in the U.S. because of existing patents and/or exclusivity rights. But the tentative approval does make the product eligible for consideration for purchase under the PEPFAR program for use in nations where PEPFAR is active.

This product is a generic formulation of Sustiva tablets, 600 mg, made by Bristol Myers Squibb Co. which is subject to existing patents, as listed in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book".

Efavirenz is a Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI) indicated for treatment of HIV infection 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

071221
FD071206

SOURCE: Food and Drug Administration (FDA).

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