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Tentative approval of Tenofovir Disoproxil Fumarate tablets

Food and Drug Administration - November 30, 2007
Richard Klein & Kimberly Struble

On November 30, 2007, FDA granted tentative approval for a generic version of Tenofovir Disoproxil Fumarate Tablets, 300 mg, manufactured by Matrix Laboratories Limited, of Hyderabad, India. The application was was reviewed under the expedited review provisions of 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, even though it is not yet eligible to be marketed in the U.S. because of existing patents and/or exclusivity rights. However, this tentative approval does make the product eligible for consideration for purchase under the PEPFAR program.

This is a generic version of Viread Tablets, 300 mg, manufactured by Gilead Sciences, Inc., which is subject to existing patent protection.

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.

Tenofovir is a nucleoside reverse transcriptase inhibitor (NRTI) indicated for treatment of HIV infection in adults and adolescents in combination with other antiretroviral agents.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


071130
FD071107

SOURCE: Food and Drug Administration (FDA).

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