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FDA Approves RISPERDAL(R) to Treat Adolescents with Schizophrenia and Children and Adolescents with Bipolar Mania
Date:8/22/2007

TITUSVILLE, N.J., Aug. 22 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today approved RISPERDAL(R) (risperidone) for the treatment of schizophrenia in adolescents ages 13-17 and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents ages 10-17.

This approval is based on studies involving more than 430 adolescents, ages 13-17, in the treatment of schizophrenia and 160 children and adolescents, ages 10-17, for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder.

RISPERDAL is marketed in the U.S. by Janssen, L.P. and promoted by McNeil Pediatrics, a division of McNeil-PPC., Inc.

Janssen is the only U.S. pharmaceutical company exclusively dedicated to mental health. For more information about RISPERDAL, visit http://www.janssen.com.

RISPERDAL(R) (risperidone) is indicated in adults for the treatment of schizophrenia, for the treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder, for the treatment of irritability associated with autistic disorder in ages 5-16 years, for the treatment of schizophrenia in adolescents ages 13-17 years and for the short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 10-17 years.

Important Safety Information For RISPERDAL(R)

Elderly Patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL(R) (risperidone) is not approved for the treatment of patients with Dementia-Related Psychosis.

The most common adverse reactions observed in all clinical trials with Risperdal occurring at a rate of at least 10% were: somnolence, appetite increased, fatigue, rhinitis, upper respiratory tract infection, vomiting, coughing, urinary i
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SOURCE Janssen, L.P.
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