FDA Approves Generic Aricept to Treat Dementia
Related to Alzheimer’s Disease
7 in 10 prescriptions in U.S. are for generic drugs;.
FDA requires generic drugs to have same quality and performance as the
brand name drugs
Dec. 16, 2009 - The U.S. Food and Drug
Administration announced yesterday it has approved the first generic
versions of Aricept (donepezil hydrochloride) orally disintegrating
tablets on Dec. 11. Donepezil hydrochloride is prescribed 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.
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About donepezil hydrochloride
By National Cancer Institute
The hydrochloride salt of a piperidine derivative with neurocognitive-enhancing
activity. Donepezil reversibly inhibits acetylcholinesterase, thereby
blocking the hydrolysis of the neurotransmitter acetylcholine and,
consequently, increasing its activity. This agent may improve
neurocognitive function in Alzheimer's disease, reduce sedation
associated with opioid treatment of cancer pain, and improve
neurocognitive function in patients who have received radiation therapy
for primary brain tumors or brain metastases. Check for
active clinical
trials or
closed clinical
trials using this agent. (NCI
Thesaurus)
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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.
For more information:
Consumer Education: Generic Drugs
