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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of tenofovir disoproxil fumarate tablets, 300 mg

On February 18, 2009, FDA granted tentative approval for generic tenofovir disoproxil fumarate tablets, 300 mg, indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR).

The application was reviewed under expedited review provisions for PEPFAR.

Manufactured by Aurobindo Pharma Limited of Hyberdad, India, this is a generic version of Viread Tablets, 300 mg, made by Gilead Sciences, Inc. Effective patent dates for all approved drugs 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, 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.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan 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