HIV/AIDS Update - Tentative approval: efavirenz, emtricitabine and tenofovir Disoproxil fumarate tablets, 600 mg/200 mg/300 mg

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Title: HIV/AIDS Update - Tentative approval: efavirenz, emtricitabine and tenofovir Disoproxil fumarate tablets, 600 mg/200 mg/300 mg

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On April 2, 2013, FDA granted tentative approval for fixed-dose efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets, 600 mg/200 mg/300 mg, indicated for use use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection, manufactured by Aurobindo Pharma Limited of Hyderabad, India. 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.

Patent information for approved drugs is available in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book.

Efavirenz is a non-nucleoside reverse transcriptase inhibitor. Emtricitabine and tenofovir disoproxil fumarate are nucleoside reverse transcriptase inhibitors. 

This is a generic version of the fixed-dose combination product, Atripla, a product of Gilead Sciences, inc..

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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