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In clinical trials, Abilify was tested against placebo-controlled groups in acutely relapsed patients with schizophrenia. Three of the four short-term trials were able to distinguish Abilify from placebo. However, in the smallest study, the trials were unable to distinguish Abilify from placebo.

A black box warning is the most serious and important warning on a prescription drug label. It is designed to call attention to the most serious or life-threatening risks of using a prescription drug.

The Department of Justice filed a lawsuit against Bristol-Myers Squibb alleging the drug company promoted Abilify for off-label use, in violation of federal law. The lawsuit alleges the drug was promoted for use in the treatment of dementia-related psychosis and for pediatric use. The lawsuit was settled for $515 million.

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