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For Consumers

Tentative approval: efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets, 600 mg/200 mg/300 mg

On February 27, 2012, FDA granted tentative approval for efavirenz, emtricitabine and tenofovir disoproxil fumarate tablets, 600 mg/200 mg/300 mg, manufactured by Cipla Ltd. of Mumbai, 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.

This product is a generic formulation of Atripla tablets, 600 mg/200mg/300mg, marketed by 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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Page Last Updated: 08/21/2014
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