Eisai Announces About the sNDA Application for ARICEPT for Treatment of Severe Alzheimer's Disease
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), was informed by the U.S. Food and Drug Administration (FDA) that the FDA did not accept a supplemental New Drug Application (sNDA) for ARICEPT (donepezil HCl tablet) submitted on August 31, 2005, for treatment of severe Alzheimer's disease (AD) because of deficiencies in the format of the application. Eisai Medical Research plans to correct the deficiencies with the objective of re-submitting the application in mid December 2005.
Eisai Co., Ltd.
Corporate Communications Department