ABILIFY (aripiprazole) Tablets ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets ABILIFY (aripiprazole) Oral Solution ABILIFY (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002 WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND ANTIDEPRESSANT DRUGS

---------------------------INDICATIONS AND USAGE---------------------------ABILIFY is an atypical antipsychotic indicated as oral formulations for the: Treatment of schizophrenia (1.1) • Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1) • Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1) Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate (1.2) • Adults: Efficacy was established in four 3-week monotherapy trials and one 6-week adjunctive trial in patients with manic or mixed episodes (14.2) • Pediatric Patients (ages 10-17): Efficacy was established in one 4­ week monotherapy trial in patients with manic or mixed episodes (14.2) Maintenance treatment of bipolar I disorder (1.2) • Adults: Efficacy was established in one maintenance trial (14.2) Adjunctive treatment of major depressive disorder (MDD) (1.3) • Adults: Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode (14.3) Treatment of irritability associated with autistic disorder (1.4) • Pediatric Patients (ages 6-17 years): Efficacy was established in two 8­ week trials in patients with autistic disorder (14.4) as an injection for the: Acute treatment of agitation associated with schizophrenia or bipolar I disorder (1.5)