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U.S. News

Aurobindo Receives Tentative FDA Approval to Produce Generic Pediatric Version of Retrovir for PEPFAR

September 12, 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 As a result, parts of this article may be outdated.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 Thursday granted tentative approval to India-based generic drug manufacturer Aurobindo Pharma to produce a generic pediatric version of GlaxoSmithKline's oral antiretroviral drug Retrovir for inclusion in the President's Emergency Plan for AIDS Relief, Reuters reports (Reuters, 9/8). The approval of Aurobindo's version of Retrovir -- known generically as zidovudine -- represents the first for a generic oral version of a pediatric-friendly antiretroviral (FDA release, 9/8). HHS in May 2004 announced plans for an FDA fast-track review program to speed the delivery of low-cost antiretrovirals -- including fixed-dose combination drugs -- to nations covered under PEPFAR. The expedited process is meant to encourage drug makers to produce generic medications to improve access to drugs in remote areas of severely affected countries and ensure the drugs' safety. 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 (Kaiser Daily HIV/AIDS Report, 7/14).

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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. © 2004 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 As a result, parts of this article may be outdated.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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