FDA approves generic donepezil hydrochloride orally disintegrating tablets

Jan 5 2010

Please note this is a corrected version of a press release that was posted to FDA's website today. The corrections include a modified headline and a revised second paragraph.

The U.S. Food and Drug Administration approved the first generic versions of Aricept (donepezil hydrochloride) orally disintegrating tablets on Dec. 11. Donepezil hydrochloride is indicated for the treatment of dementia related to Alzheimer's disease.

Orally disintegrating tablets dissolve on the tongue, without having to be swallowed whole. This may make it easier to take the medication for older or disabled patients who have difficulty swallowing.  

"Generics offer greater access to health care for all Americans," said Gary Buehler, director of the FDA's Office of Generic Drugs. "Health care 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." 

Alzheimer's disease is an irreversible, progressive brain disease that slowly destroys memory and thinking skills and, eventually, the ability to carry out the simplest tasks of daily living. In most people with Alzheimer's disease, symptoms first appear after age 60. Alzheimer's disease is the most common cause of dementia among older people, but it is not a normal part of aging.

Dementia refers to a decline in cognitive function that interferes with daily life and activities. Alzheimer's disease starts in a region of the brain that affects recent memory, then gradually spreads to other parts of the brain.

The generic donepezil hydrochloride orally disintegrating tablets, manufactured by Mutual Pharmaceutical of Philadelphia, have been approved in 5 milligram and 10 mg strengths.