U.S. Drug Agency Preliminarily Approves Generic Version of AIDS Medicine
Posted on: Thursday, 22 December 2005, 09:00 CST
U.S. drug agency preliminarily approves generic version of AIDS medicine
WASHINGTON, Dec. 21 (Xinhua) -- 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 agency said.
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 relief plan.
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.
Source: Xinhua News Agency - CEIS
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