Alzheimer Disease

sNDA application for ARICEPT resubmitted

Published in Medical Letter on the CDC and FDA, January 22nd, 2006

Eisai Co., Ltd. and Eisai Inc. have announced that a reformatted version of the supplemental New Drug Application (sNDA) for ARICEPT (donepezil HCl tablets) for treatment of severe Alzheimer's disease has been resubmitted to the U.S. Food and Drug Administration (FDA).

Eisai Medical Research Inc. submitted the revised application in December 2005. The sNDA was originally submitted on August 31, 2005, but the FDA did not accept the application for filing due to deficiencies in its format.

An acceptance decision regarding the sNDA resubmission will be made by FDA within 60 days after receipt and review of its contents, according to FDA's usual...

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Source: Medical Letter on the CDC and FDA (2006-01-22)

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