Summaries of health policy coverage from major news organizations
Aurobindo Receives Tentative FDA Approval To Produce Generic Oral Solution Version of Antiretroviral Epivir for PEPFAR
FDA on Friday granted tentative approval to Indian generic drug manufacturer Aurobindo Pharma to produce a generic version of GlaxoSmithKline's oral formulation of Epivir for inclusion in the President's Emergency Plan for AIDS Relief, Reuters reports. GSK's oral formulation of Epivir -- known generically as lamivudine -- is intended for use by HIV-positive children ages three months to 16 years in combination with other drugs (Reuters, 11/4). HHS in May 2004 announced plans for a new FDA fast-track review program to speed the delivery of low-cost antiretroviral 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, 7/11).
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