
AsianScientist (Mar. 7, 2014) – Indian pharmaceutical manufacturer Cipla Ltd has been granted tentative FDA approval for the production of a generic human immunodeficiency virus (HIV) drug.
The fixed dose of formulation of emtricitabine and tenofovir disoproxil fumarate, indicated for use in combination with other antiretroviral agents for the treatment of HIV, 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.
Generic drugs are desperately needed, especially in developing countries where many HIV patients cannot afford costly, long-term antiretroviral treatment.
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Source: U.S. Food and Drug Administration; Photo: Terri Ford.Global/Flickr/CC.
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