WEDNESDAY, April 29, 2015 (HealthDay News) -- The first generic versions of the atypical antipsychotic drug Abilify (aripiprazole) have been approved by the U.S. Food and Drug Administration to treat schizophrenia or bipolar disorder.
License to produce the drug in multiple strengths was approved for Alembic Pharmaceuticals, Hetero Labs, Teva Pharmaceuticals, and Torrent Pharmaceuticals, the agency said in a news release.
Bipolar disorder, also known as manic depression or manic-depressive illness, is a brain disorder that causes unusual moods and activities, affecting the ability to carry out day-to-day tasks. Symptoms typically include alternating periods of depression (lows) and increased activity and restlessness (highs).
Schizophrenia, another brain disorder, affects about 1 percent of Americans. Symptoms typically begin in people younger than 30, and include hearing voices, believing other people are controlling their minds or actions, and being suspicious and withdrawn.
As with other atypical antipsychotic drugs, generic Abilify's label will contain the FDA's most stringent boxed warning that the medication poses an increased risk of death among older people with dementia-related psychosis. The label also warns of an increased risk of suicidal thinking and behavior among children, teens and young adults.
The most common side effects of the drug are nausea, vomiting, constipation, headache, dizziness, body twitching, anxiety, insomnia and restlessness.
The FDA release included a statement that approved generic drugs are produced to the same quality standards as their brand-name counterparts.
Visit the FDA to learn more about this approval.