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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of generic zidovudine, 100 mg capsules

The Food and Drug Administration, on March 27, 2006, granted tentative approval for zidovudine 100 mg capsules manufactured by Aurobindo Pharma Limited Inc., of Hyderabad, India. This is a generic version of the already-approved Retrovir brand of the product manufactured by GlaxoSmithKline.

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, though it may not yet be marketed in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR) program.

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

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration