Eisai Co., Ltd. Confirms Receipt of FDA Approvable Letter
In response to various inquires, Eisai Co., Ltd. of Tokyo confirms that the U.S. Food and Drug Administration (FDA) has issued an approvable letter to Eisai America, Inc. for ARICEPT(TM) (donepezil hydrochloride or E2020), an investigational new drug for mild to moderate Alzheimer's disease. Eisai America is the U.S. subsidiary that submitted the ARICEPT(TM) NDA on March 29 of this year. An approvable letter is issued during the final stages of the U.S. FDA review process.