In Brief: Food and Drug Administration
Wednesday, December 03 2008 | Comments
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A Food and Drug Administration advisory panel deemed Novartis AG's Coartem (artemether/lumefantrine) to be safe and effective in the treatment of malaria, Reuters reported. Novartis is seeking approval to market the drug in the United States, though it is already used widely in other parts of the world, including Africa and Asia. Because Novartis does not expect to reap much monetary benefit from the drug in the United States, it will receive a special FDA voucher upon Coartem's approval that would allow the company to receive an accelerated six-month review for any other investigational drug, which could potentially allow a more profitable drug to reach market sooner, Reuters added. The panel's decision was based on data from more than 3,400 Coartem-treated patients, according to The Associated Press. Print |
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