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Feb 13, 2012 12:45AM GMT
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Novartis malaria drug safe, effective-US FDA staff
By Reuters | General News | Dec 01, 2008 02:29PM GMT
Reuters
WASHINGTON, Dec 1 (Reuters) - Data show Novartis AG's combination malaria drug Coartem appears to work and causes few serious side effects, U.S. Food and Drug Administration regulatory staff said in documents released on Monday.
"The majority of AEs (adverse events) were of mild or moderate intensity. Deaths ... and SAEs (serious adverse events) ... were reported infrequently," the staff wrote in documents released ahead of an FDA advisory panel meeting on Wednesday to discuss the drug.
The Swiss drugmaker is seeking FDA approval for the drug, which combines artemether and lumefantrine, to treat acute, uncomplicated malaria infections. (Reporting by Susan Heavey, editing by Gerald E. McCormick)
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