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U.S. Department of Health and Human Services

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Tentative approval of emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg

On July 31, 2013, FDA granted tentative approval for emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg made by Strides Arcolab Limited of Bnagalore, India. The product is indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection.

The application 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, 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 PEPFAR program.

This is a generic version of Truvada, 200 mg/300 mg tablets, manufactured by Gilead Sciences.

Patent information for all approved drugs is available in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book.
 
Emtricitabine and tenofovir disoproxil fumarate are nucleoside reverse transcriptase inhibitors. 
 
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.
 

Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration

 
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