Food and Drug Administration - December 24, 2008
Richard Klein & Kimberly Struble

On December 23, 2008, FDA granted tentative approval for a generic version of emtricitabine capsules 200 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India, reviewed under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR). Emtricitabine is a Nuceloside Reverse Transcriptase Inhibitor (NRTI) indicated in combination with other antiretroviral medications for teatment of HIV infection.

"Tentative approval" means that FDA has concluded that a drug product has met the 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 under the PEPFAR program.

This tentative approval is for a generic formulation of Emtriva Capsules, 200 mg made by Gilead Sciences, Inc., which is subject to patent protection and pediatric exclusivity. 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 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.

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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