US FDA Tentative Approval for ANDA Filing of Donepezil Hydrochloride TEANECK, N.J., Feb. 25 /PRNewswire-FirstCall/ -- U.S. Food & Drug Administration (FDA) announced on their website that FDA has issued a tentative approval for donepezil hydrochloride to Ranbaxy Laboratories Ltd. Donepezil is Eisai's branded medicine Aricept(R). The tentative approval by FDA does not authorize Ranbaxy Laboratories Ltd. to sell and market donepezil hydrochloride before the expiry of Eisai's product patent. Eisai's donepezil will be protected at least until its product patent expiry in November 2010. The tentative approval will not be final before November 2010. DATASOURCE: Eisai Co., Ltd.; Eisai Inc. CONTACT: Eisai Co., Ltd., Corporate Communications Department, +81-3-3817-5120; or Cathy Pollini, Corporate Public Relations, Eisai Inc., +1-201-287-2052

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