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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
Date:11/20/2007

over 12.5 million prescriptions have been written for ABILIFY in the U.S.(10) through June 2007.

ABILIFY is available by prescription only. ABILIFY Tablets should be taken once daily with or without food and are available in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg strengths. As adjunctive treatment to antidepressant therapy in adults with major depressive disorder, ABILIFY Oral starting dose is 2 mg/day to 5 mg/day with a maximum dose of 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than one week.

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY

INDICATIONS:

-- ABILIFY is indicated for use as an adjunctive treatment to

antidepressants for major depressive disorder in adults.

IMPORTANT SAFETY INFORMATION:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of patients with dementia-related psychosis (see Boxed WARNING).

Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD). Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of therapy, or at times of dose changes. ABILIFY is not approved for use in pediatric patients with depression (See Boxed WARNING).

Cerebrovascular adverse events (eg, stroke, transient ischemic attack),

including fatalities, have been reported at an increased incidence in

clinical trials of elderly patients with dementia-related psychosis

treated with ABILIFY

Neuroleptic malignant syndrome (NMS)-As with all antipsychotic

medications, a rare and pot
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SOURCE Bristol-Myers Squibb Company and Otsuka PharmaceuticalCo., Ltd.
Copyright©2007 PR Newswire.
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