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International News

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

From Henry J. Kaiser Family Foundation

December 22, 2005

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!

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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Reprinted with permission from kaisernetwork.org. You can view the entire Kaiser Daily HIV/AIDS Report, search the archives, or sign up for email delivery at www.kaisernetwork.org/dailyreports/hiv. The Kaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service of the Kaiser Family Foundation, by The Advisory Board Company. © 2005 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.

A note from TheBody.com: Since this article was written, the HIV pandemic has changed, as has our understanding of HIV/AIDS and its treatment. As a result, parts of this article may be outdated. Please keep this in mind, and be sure to visit other parts of our site for more recent information!




  
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.
 
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