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