Approval of risperidone in the USA for use by adolescents with schizophrenia or bipolar mania extends treatment options for these young patients

Recent approval of risperidone by the U.S. Food and Drug Administration for use by adolescents with schizophrenia or bipolar mania extends treatment options for these young patients.

The approval is for use of risperidone as treatment for schizophrenia in patients age 13 to 17 years and for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder in children and adolescents age 10 to17 years.

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

Current indications for risperidone use in the USA are for adults with schizophrenia, for treatment of manic symptoms of acute manic or mixed episodes associated with bipolar I disorder, for treatment of irritability associated with autistic disorder in pediatric patients age 5 to16 years, for treatment of schizophrenia in adolescents ages 13 to 17 years and for short-term treatment of bipolar mania associated with bipolar I disorder in children and adolescents ages 10 to 17 years.


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