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

July 11, 2005

FDA on Friday granted tentative approval to Indian generic drug manufacturer Aurobindo Pharma to produce a generic version of GlaxoSmithKline's Combivir for inclusion in the President's Emergency Plan for AIDS Relief, Reuters reports. Combivir is a fixed-dose combination of the antiretroviral drugs lamivudine and zidovudine. The combination drug is the first FDC to gain FDA approval for distribution under PEPFAR, HHS Secretary Mike Leavitt said (Reuters, 7/8). HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral drugs -- 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 United States because of existing patents or exclusivity agreements (Kaiser Daily HIV/AIDS Report, 7/5). FDA has granted tentative approval of several of Aurobindo's antiretroviral drugs (Reuters, 7/8).

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