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Wednesday, April 29, 2015

FDA APPROVES FIRST GENERIC VERSIONS OF DRUG APPROVED TO TREAT SCHIZOPHRENIA, BIPOLAR DISORDER

FROM:  U.S. FOOD AND DRUG ADMINISTRATION

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by 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.

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include hearing voices, believing other people are reading their minds or controlling thoughts and being suspicious or withdrawn.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.