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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of emtricitabine/tenofovir disoproxyl fumarate tablets for PEPFAR

On December 22, 2011, FDA granted tentative approval for a fixed dose combination tablet of emtricitabine; tenofovir disoproxyl fumarate, 200 mg/300 mg.  The tablet is manufactured by Hetero Labs Limited of Hyderabad, India.

"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the President's Emergency Plan for AIDS Relief (PEPFAR) program. This product was reviewed under expedited review provisions for PEPFAR.

This is a generic version of Truvada Tablets, 200 mg/300 mg, of Gilead Sciences Inc., which continues to be subject to patent protections.

Patent information is available in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to 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, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.

You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration