FDA tentatively
OK's generic anti-HIV drug

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)