FDA Won't Pull Pfizer Alzheimer's Drug From Market

Law360, New York (November 7, 2012, 3:35 PM EST) -- The U.S. Food and Drug Administration on Tuesday rejected a consumer advocacy group's bid to pull a Pfizer Inc. Alzheimer's drug over efficacy and safety concerns, saying the lack of drugs on the market may justify the side effects.

The agency rejected Public Citizen Inc.'s petition that argued a 23-milligram dose of Aricept, manufactured by Eisai Co. Ltd. and marketed by Pfizer, failed to meet agency-required efficacy criteria for dementia drugs and demonstrated significantly more adverse effects compared with a lower 10-milligram dose.

“For a disease...
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