Eisai Co., Ltd. (Headquarters: Tokyo, President and CEO Haruo Naito) announced today that its U.S. subsidiary, Eisai Medical Research Inc. (Headquarters: New Jersey, President: Mindell Seidlin), corrected the deficiencies in the format of the supplemental New Drug Application (sNDA) for Aricept
(donepezil HCl tablet) and resubmitted a reformatted application to the FDA (U.S. Food and Drug Administration) on December 16, 2005. Eisai Medical Research initially submitted the sNDA on August 31, 2005, but FDA did not accept the submission for filing due to the deficiencies in its format.
The reformatted version of the sNDA will be formally accepted within 60 days after the receipt and review of its contents by FDA, based on the FDA’s usual procedure. Eisai will issue a press release at the time of formal receipt by the FDA.
Corporate Communications Department
Eisai Co., Ltd.