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Aurobindo Pharma Receives Tentative FDA Approval to Produce Pediatric Version of Generic Antiretroviral Stavudine for PEPFAR

December 22, 2005

This article is part of The Body PRO's archive. Because it contains information that may no longer be accurate, this article should only be considered a historical document.

FDA on Wednesday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce the generic antiretroviral drug stavudine for pediatric use, the AP/Washington Post reports (AP/Washington Post, 12/21). Stavudine, manufactured by Bristol-Myers Squibb under the brand name Zerit, is used in combination with other antiretrovirals to treat HIV infection (Kaiser Daily HIV/AIDS Report, 7/5). The tentative approval designation means the generic drug meets FDA safety and efficacy standards but cannot be sold in the U.S. because of existing patents or exclusivity agreements, although it can be used by relief organizations outside the U.S. under the President's Emergency Plan for AIDS Relief (Xinhuanet, 12/22).

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