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For Consumers

Tentative approval for generic Tenofovir Disoproxil Fumarate Tablets, 300 mg

On April 6, 2010, the Food and Drug Administration granted tentative approval for generic Tenofovir Disoproxil Fumarate Tablets, 300 mg, under expedited review procedures for the President's Emergency Plan for AIDS Relief (PEPFAR).

This generic formulation, manufactured by Hetero Drugs, Ltd.,of Hyberdad, India, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.

FDA's tentative approval of this product means that while FDA cannot fully approve the product for sale in the United States because of existing patent protections, it has been shown to meet all of FDA's safety, efficacy and manufacturing quality standards. Tentative approval qualifies the product for purchase outside the United States using PEPFAR funds.

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 Plan3 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

Page Last Updated: 08/21/2014
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