The US Food and Drug Administration (FDA) has approved donepezil hydrochloride in the US as a generic version of Aricept, for the treatment of dementia related to Alzheimer’s disease.
The approval is the first for a generic version of Eisai’s Aricept (donepezil hydrochloride) orally disintegrating tablets, which are used as an easily disintegrating tablet solution for older or disabled patients who have difficulty swallowing.
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The FDA’s Office of Generic Drugs director Gary Buehler said that generics offer greater access to healthcare for all Americans.
“Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug,” Buehler said.
The generic donepezil hydrochloride orally disintegrating tablets, manufactured by Mutual Pharmaceutical of Philadelphia, have been approved in 5mg and 10mg strengths.
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