Alzheimer Disease

U.S. FDA accepts sNDA for ARICEPT in the treatment of severe Alzheimer disease

Published in Medical Letter on the CDC and FDA, March 19th, 2006

Eisai Co., Ltd., and Eisai, Inc., announced that the U.S. Food & Drug Administration (FDA) has accepted a supplemental new drug application (sNDA) for ARICEPT (donepezil HCl tablets) for treatment of severe Alzheimer disease.

Eisai Medical Research, Inc., submitted the revised application on December 16, 2005.

ARICEPT, which is copromoted in the United States by Eisai, Inc., and Pfizer, Inc., is currently approved for treatment of mild-to-moderate Alzheimer disease.

ARICEPT is an acetylcholinesterase inhibitor and is believed to work by inhibiting the breakdown of acetylcholine, thereby increasing available levels of this chemical...

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Source: Medical Letter on the CDC and FDA (2006-03-19)

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