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The Food and Drug Administration today (July 13, 2005) announced the tentative approval of zidovudine tablets manufactured by Ranbaxy Laboratories Limited of Guragon, India.  The product contains 300 mg of zidovudine in each tablet.  It is a generic version of the already-approved Retrovir brand of the product manufactured by GlaxoSmithKline. 

Tentative approval means that although existing patents and/or exclusivity prevent marketing of this product in the United States, it meets the quality, safety and efficacy standards for U.S. marketing.

Tentative approval by FDA makes this Ranbaxy generic product eligible for purchase and use outside the United States under the President's Emergency Plan for AIDS Relief.

Zidovudine is a nucleoside reverse transcriptase inhibitor (NRTIs), intended to be used with other antiretroviral agents for the treatment of HIV-1 infection.

Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration

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