Summaries of health policy coverage from major news organizations
Aurobindo Pharma Receives Tentative FDA Approval To Produce Generic Antiretroviral Lamivudine for PEPFAR
FDA on Wednesday granted tentative approval to Indian drug manufacturer Aurobindo Pharma to produce a generic version of the antiretroviral drug lamivudine, qualifying the drug to be included in the President's Emergency Plan for AIDS Relief, Reuters reports (Reuters, 6/15). 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 (Kaiser Daily HIV/AIDS Report, 6/1). Under tentative approval, the generic drug cannot be marketed in the United States (FDA release, 6/15).
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