HHS Food and Drug Administration Grants Tentative Approval for 50th and 51st Anti-Retroviral Drugs under the President's Emergency Plan for AIDS ReliefAugust 15, 2007 – The Food and Drug Administration (FDA) within the U.S. Department of Health and Human Services recently granted tentative approval for the 50th and 51st AIDS drugs approved or tentatively approved for purchase under the President's Emergency Plan for AIDS Relief (PEPFAR). One of these, a pediatric triple-fixed-dose combination tablet of lamivudine, stavudine and nevirapine, is the first fixed-dose, anti-HIV product designed to treat children under the age of 12 years. In May 2004, in support of the President's Emergency Plan, HHS/FDA announced a new initiative to help ensure that those served by the President’s Emergency Plan would receive safe, effective, and quality manufactured antiretroviral drugs. HHS/FDA actively encouraged pharmaceutical manufacturers worldwide to submit U.S. marketing applications for single-entity, fixed-dose combination (FDC), and co-packaged versions of previously approved antiretroviral therapies, even if there were still patent or exclusivity market protection for the products in the United States. HHS/FDA's tentative approval means that, although existing patents and/or marketing exclusivity prevent the approval of the product in the United States, the product meets all of HHS/FDA's manufacturing quality and clinical safety and efficacy requirements. This helps to ensure AIDS patients abroad who receive these medications get the same quality of medications as Americans. Moreover, host-country Governments and other partners outside the United States can purchase all 51 of the drugs with U.S. Government funds. For more information:
Last revised: October 11, 2007 | 
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