Henry J. Kaiser Family Foundation • International News

Aurobindo Receives Tentative FDA Approval to Produce Oral Version of Generic Antiretroviral Abacavir for PEPFAR

June 29, 2006

FDA on Tuesday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce an oral version of the antiretroviral drug abacavir for pediatric use in children ages three months to 13 years under the President's Emergency Plan for AIDS Relief, Reuters reports (Reuters, 6/27). The tentative approval designation means the 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 PEPFAR (Kaiser Daily HIV/AIDS Report, 1/5).

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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. © 2006 by The Advisory Board Company and Kaiser Family Foundation. All rights reserved.

This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report.

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