A generic version
of a pediatric anti-HIV 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 of
Hyderabad, India. The oral version of stavudine 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 it 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. (AP)