US FDA Tentative Approval for ANDA Filing of Donepezil Hydrochloride
Eisai Co., Ltd.
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 .
The tentative approval by FDA does not authorize Ranbaxy Laboratories Ltd. to sell and market donepezil hydrochloride before the expiry of the 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 effective before November 2010.