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FDA Approves First Generic HIV/AIDS Drug in Capsule Form for United States Market

March 31, 2006

The Food and Drug Administration (FDA), an agency of the U.S. Department of Health and Human Services today issued the first generic approval for the capsule dosage form of zidovudine (zye-DOE-vue-deen) to treat HIV/AIDS to be marketed in the United States. The tablet and oral solution dosage forms of zidovudine were previously approved for sale in the United States when the patent on those dosage forms expired in September 2005. Today's approval for the capsule formulation of the drug, which is manufactured by Aurobindo Pharma LTD. in Hyderabad, India, follows the expiration of GlaxoSmithKline's patent on its capsule form of the product marketed under the tradename Retrovir.

"This is a significant generic approval," said Dr. Andrew C. von Eschenbach, Acting Commissioner of Food and Drugs. "Retrovir, which was initially approved in March, 1987, was the first of a group of breakthrough medications that have transformed what was then a disease with a very dismal prognosis into one with a much more hopeful prognosis. Approval of this additional dosage form of zidovudine should help reduce the cost of this therapy for American patients."

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

The agency's approval of zidovudine means that there are no existing patents and/or exclusivity preventing the approval of generic versions of this product. As with all FDA-approved generics, this product must meet all of FDA's manufacturing quality, and clinical safety and effectiveness standards for U.S. marketing. More information on HIV and AIDS is available online at FDA's website: www.fda.gov/oashi/aids/hiv.html.



  
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This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 
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