FDA Urged To Pull Eisai's High-Dose Aricept

Law360, New York (May 19, 2011, 5:46 PM EDT) -- A nonprofit consumer advocacy group urged the U.S. Food and Drug Administration on Wednesday to immediately yank the highest dose of Alzheimer's disease drug Aricept from the market due to its alleged lack of effectiveness and risk of serious effects.

In a petition filed with the FDA, Public Citizen contended that in the primary clinical trial the 23-milligram dose of Aricept, marketed by developer Eisai Co. Ltd. and partner Pfizer Inc., failed to meet efficacy criteria required by the FDA for approval of dementia drugs. It...
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