FDA Approves Alzheimer’s Generic

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.

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.