REGULATORY

Aricept’s Lewy Body Dementia Indication to Be Modified after Post-Launch Trial Miss

By Yoshinori Sagehashi October 31, 2022
For the first time in more than 14 years, the Japanese health ministry is requiring a partial change of approval under its pharmaceutical reexamination system. Eisai’s Aricept (donepezil) now braces for such modification process, which also entails a label revision,…

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