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FDA Approves First Generic Abilify

For treatment of bipolar disorder or schizophrenia

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.

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, akathisia, anxiety, insomnia, and restlessness.

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