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FDA Approves First Generic Abilify to Treat Mental Illnesses

Four companies vie with Otsuka for schizophrenia, bipolar patients

The FDA has given the nod to the first generic versions of Abilify (aripiprazole, Otsuka America Pharmaceutical, Inc.). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.

Alembic Pharmaceuticals, Hetero Labs Ltd., Teva Pharmaceuticals, and Torrent Pharmaceuticals 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, MD, acting director of the Office of Generic Drugs at 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. Approximately 1% of Americans have the illness. Typically, symptoms are first seen in adults younger than 30 years of age. The symptoms of schizophrenia include hearing voices, believing other people are reading their minds or controlling their thoughts, and being suspicious or withdrawn.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.

The labeling for all atypical antipsychotics contains 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 includes an increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Patients should be monitored for the emergence or worsening of suicidal thoughts and behaviors. Aripiprazole must be dispensed with a medication guide that describes important information about the drug’s uses and risks.

In clinical studies of aripiprazole, the most common adverse events reported by adults included nausea, vomiting, constipation, headache, dizziness, akathisia, anxiety, insomnia, and restlessness.

Source: FDA; April 28, 2015.

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