Aurobindo Receives Tentative FDA Approval to Produce Generic Pediatric Version of Retrovir for PEPFAR
September 12, 2005
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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