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Associated Press
FDA Tentatively OKs Generic AIDS Drug

December 21, 2005
WASHINGTON - A generic version of a pediatric AIDS drug received preliminary approval Wednesday from the Food and Drug Administration.

The FDA said it was giving tentative approval for Stavudine, an antiretroviral drug considered child-friendly that is manufactured by Aurobindo Pharma Ltd. of Hyderabad, India.

Stavudine for oral solution is the first generic version of the previously approved Zerit for oral solution manufactured by Bristol-Myers Squibb.

The generic version meets FDA manufacturing, safety and efficacy standards but will not be marketed in the United States for patent exclusivity reasons, the agency said.

The approval does mean, however, that the generic version can be used by relief organizations outside the United States funded by President Bush's $15 billion AIDS relief plan.

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On the Net:

FDA information on HIV/AIDS: www.fda.gov/oashi/aids/hiv.html



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