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On February 26, 2014 FDA granted tentative approval for a generic formulation of emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, manufactured by Cipla Limited of Mumbai, India.
The fixed dose combination drug, indicated for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV)-1 infection, is a generic version of Truvada tablets, manufactured by Gilead Sciences, Inc.
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.
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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