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U.S. Department of Health and Human Services

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Tentative approval, tenofovir disoproxil fumarate tablets, 300 mg

On April 29, 2009, FDA granted tentative approval for tenofovir disoproxil fumarate tablets, 300 mg, manufactured by Cipla, Limited, of Mumbai, India, indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).

"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 consideration for purchase outside the United States under the PEPFAR program.

This product is a generic verision of Viread Tablets, 300 mg, a Nucleoside Reverse Transcriptase Inhibitor (NRTI), made by Gilead Sciences Inc.  Patent information is available in the FDA 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