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Tentative approval of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets

<p>Richard Klein, Kimberly Struble and Steve Morin</p>


June 27, 2013

On June 26, 2013, FDA granted tentative approval for a fixed-dose combination of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg, for use alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and adolescents over 16 years of age and weighing at least 40 kg. 

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

This product is manufactured by Aurobindo Pharma Limited of Hyderabad, India.

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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