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International News

Cipla Receives Tentative FDA Approval to Produce Oral Form of Generic Antiretroviral Lamivudine for PEPFAR

June 28, 2006

Indian drugmaker Cipla has received tentative FDA approval to produce an oral version of the antiretroviral drug lamivudine, a generic version of GlaxoSmithKline's Epivir, under the President's Emergency Plan for AIDS Relief, India's Hindu reports (Hindu, 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 (Kaiser Daily HIV/AIDS Report, 5/31). The tentative approval allows Cipla to produce for PEPFAR an oral solution of lamivudine, which belongs to a drug class called nucleoside reverse transcriptase inhibitors, at strengths of 10mg per ml, the Hindu reports (Hindu, 6/27).

Back to other news for June 28, 2006


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.



  
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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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