FDA: The U.S. Food and Drug Administration today approved the first
generic versions of Abilify (aripiprazole). Generic aripiprazole is an
atypical antipsychotic drug approved to treat schizophrenia and bipolar
disorder. Alembic Pharmaceuticals Ltd., Hetero Labs Ltd., Teva
Pharmaceuticals and Torrent Pharmaceuticals Ltd. have received FDA
approval to market generic aripiprazole in multiple strengths and dosage
forms. “Having access to treatments is important for patients
with long-term health conditions,” said John Peters, M.D., acting
director of the Office of Generic Drugs in the FDA’s Center for Drug
Evaluation and Research. “Health care professionals and consumers can be
assured that FDA-approved generic drugs have met the same rigorous
standards as the brand-name drug.”
Schizophrenia is a chronic,
severe and disabling brain disorder. About one percent of Americans have
this illness. Typically, symptoms are first seen in adults younger than
30 years of age. Symptoms of schizophrenia include hearing voices,
believing other people are reading their minds or controlling thoughts
and being suspicious or withdrawn.
Bipolar disorder, also known as
manic-depressive illness, is another brain disorder that causes unusual
shifts in mood, energy, activity levels and the ability to carry out
day-to-day tasks. The symptoms of bipolar disorder include alternating
periods of depression and high or irritable mood, increased activity and
restlessness, racing thoughts, talking fast, impulsive behavior and a
decreased need for sleep.
All atypical antipsychotics contain a
Boxed Warning alerting health care professionals about an increased risk
of death associated with the off-label use of these drugs to treat
behavioral problems in older people with dementia-related psychosis. No
drug in this class is approved to treat patients with dementia-related
psychosis.
Aripiprazole’s Boxed Warning also warns about an
increased risk of suicidal thinking and behavior in children,
adolescents, and young adults taking antidepressants. Patients should be
monitored for worsening and emergence of suicidal thoughts and
behaviors. Aripiprazole must be dispensed with a patient Medication
Guide that describes important information about the drug’s uses and
risks.
In the clinical trials for Abilify, the most common side
effects reported by adults taking Abilify were nausea, vomiting,
constipation, headache, dizziness, uncontrollable limb and body
movements (akathisia), anxiety, insomnia, and restlessness.
Generic
prescription drugs approved by the FDA have the same high quality and
strength as brand-name drugs. Generic prescription drug manufacturing
and packaging sites must pass the same quality standards as those of
brand-name drugs.
The FDA, an agency within the U.S. Department of
Health and Human Services, protects the public health by assuring the
safety, effectiveness, and security of human and veterinary drugs,
vaccines and other biological products for human use, and medical
devices. The agency also is responsible for the safety and security of
our nation’s food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco products.