WASHINGTON, Dec. 21 (Xinhuanet) -- The U.S. Food and Drug Administration (FDA)
said Wednesday that it was giving tentative approval to a generic version of a
pediatric AIDS drug.
Stavudine, an antiretroviral drug manufactured by India's Aurobindo Pharma
Ltd., meets FDA manufacturing, safety and efficacy standards and is considered
safe for children, the agencysaid.
But due to patent exclusivity reasons, the generic version can not be
marketed in the United States. But if finally approved, it can be used by relief
organizations outside the United States funded by President George Bush's AIDS
Stavudine for oral solution is the first generic version of the previously
approved Zerit for oral solution manufactured by U.S. pharmaceutical giant
Bristol-Myers Squibb. Enditem