Eisai Inc.
FDA Accepts Once Daily 23 mg Aricept Extended Release NDA for Review
Published in FDA Law Weekly, December 10th, 2009
Eisai Inc. and Pfizer Inc announced that the U.S. Food and Drug Administration (FDA) has accepted for review Eisai's New Drug Application (NDA) for once daily 23 mg Aricept® (donepezil HCl extended release) tablets for the treatment of moderate to severe Alzheimer's disease (AD). This new higher dose formulation contains 23 mg of donepezil HCl in an extended release, matrix-type tablet with a delivery system that allows for gradual release of the drug. The NDA is based on a head-to-head clinical study comparing the 23 mg Aricept extended release tablet to the currently marketed once daily 10 mg Aricept® (donepezil HCl) immediate release tablet. More than 1400 patients with...
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Source: FDA Law Weekly (2009-12-10)
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