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FDA approves generic treatment of Alzheimer’s disease


ROCKVILLE, Md. The Food and Drug Administration has approved the first generic version of a drug used to treat dementia related to Alzheimer’s disease, the agency announced Tuesday.

The FDA approved Philadelphia-based Mutual Pharmaceutical’s donepezil hydrochloride orally disintegrating tablets in the 5-mg and 10-mg strengths, a generic version of Eisai’s Aricept. While generic versions of Aricept already are available, the newly approved generic is a version that dissolves on the tongue, designed for patients who have difficulty swallowing.

“Generics offer greater access to health care for all Americans,” FDA Office of Generic Drugs director Gary Buehler said. “Healthcare professionals and consumers can be assured that FDA-approved generic drugs have met the same rigorous standards as the brand-name drug and are the same as the branded in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

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