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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of generic lamivudine/zidovudine combination

The Food and Drug Administration (FDA), on July 7, 2005, announced the tentative approval of a generic combination drug product consisting of lamivudine and zidovudine, manufactured by Aurobindo Pharma LTD. Hyderabad, India.

FDA tentative approval means that the product meets all of FDA’s quality, safety and efficacy standards, but existing patents and/or exclusivity prevent marketing of the product in the U.S. Tentative approval by FDA, however, makes this Aurobindo generic product available for consideration for purchase and use outside the United States under the President’s Emergency Plan for AIDS Relief (PEPFAR).

The Aurobindo lamivudine/zidovudine combination product is a generic version of the U.S. approved Combivir lamivudine/zidovudine combination manufactured by GlaxoSmithKline.

Lamivudine and Zidovudine are both nucleoside reverse transcriptase inhibitors (NRTIs), which help keep the AIDS virus from reproducing. This combination antiretroviral drug is intended to be used with other antiretroviral agents in the treatment of HIV-1 infection.

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