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US FDA to reivew extended-release Aricept NDA
25 November 2009
Katie McQue
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25 November 2009
Katie McQue
katie.mcque@informa.com
The US FDA has accepted for review Pfizer and Eisai's NDA for a higher-dose 23mg once-daily extended-release formulation of their Alzheimer's drug Aricept (donepezil HCl extended release).
The NDA is based in a 1,400 patient head-to-head study comparing the 23mg formulation of Aricept to...
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