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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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.