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Aurobindo Receives Tentative FDA Approval To Produce Oral Version of Generic Antiretroviral Nevirapine for PEPFAR
FDA last week granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce an oral version of the antiretroviral drug nevirapine for pediatric use under the President's Emergency Plan for AIDS Relief, the UNI/newKerala.com reports. The approval is for 50-milligram/five milliliter oral solution of nevirapine, which is sold under the brand name Viramune by Boehringer Ingelheim (UNI/newKerala.com, 1/3). 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, 6/21/05).
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