U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Yea... (cally indicatedoral ABILIFY in a range o...)

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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)

Date:2/29/2008

cally indicated, oral ABILIFY in a range of 10 mg/day to 30 mg/day should replace ABILIFY Injection as soon as possible. The safety of doses of ABILIFY Oral or ABILIFY Injection above 30 mg/day has not been evaluated in clinical trials.

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY

INDICATIONS:

-- ABILIFY is indicated for acute and maintenance treatment of adults

with manic or mixed episodes associated with Bipolar I Disorder with

or without psychotic features

-- ABILIFY is indicated for acute treatment of pediatric patients (10 to

17 years old) with manic or mixed episodes associated with Bipolar I

Disorder with or without psychotic features

-- ABILIFY Injection is indicated for the treatment of adults with

agitation associated with Bipolar I Disorder, manic or mixed.

IMPORTANT SAFETY INFORMATION:

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs 2.6%, respectively). 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) and other psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or another antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increased risk of suicidality in adults beyond age 24. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusu
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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Yea...(cally indicatedoral ABILIFY in a range o...),Health