Food and Drug Administration - July 13, 2007

FDA granted tentative approval on July 12, 2007 for a generic formulation of efavirenz tablets, 600 mg, manufactured by Matrix Laboratories Limited, of Hyderabad, India, under expedited review provisions developed for the President's Emergency Plan for AIDS Relief (PEPFAR).

This is a generic formulation of already approved Sustiva tablets, 600 mg, made by Bristol Myers-Squibb, which is protected by existing patent rights.

"Tentative Approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but because of existing patents and/or exclusivity rights, it cannot yet be marketed in the United States. Effective patent dates are listed in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book""

Tentative approval does, however make the product eligible for consideration for purchase under the PEPFAR program for use outside the United States.

As with all generic applications submitted to the agency, 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 evaluate the ability of the manufacturer to produce a quality product, and to assess the quality of the bioequivalence data supporting the application.

Efavirenz is a Nonnucleoside Reverse Transcriptase Inhibitors (NNRTI) indicated for treatment of HIV infection in combination with other antiretroviral agents.
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SOURCE: Food and Drug Administration (FDA).

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