FDA-requested pediatric studies provide valuable clinical evidence on the safety, efficacy, and dosage of antipsychotic drugs in children and adolescents.
The U.S. Food and Drug Administration (FDA) has approved the use of risperidone (Risperdal) in children and adolescents to treat schizophrenia and mania or mixed episodes of bipolar I disorder, making it the first atypical antipsychotic drug approved for either disorder in young patients.
The FDA announced last month that risperidone is approved for the treatment of schizophrenia in adolescents aged 13 to 17 and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents aged 10 to 17. Risperidone was approved in October 2006 for treating irritability associated with autistic disorders in children and adolescents aged 5 to 16 years.
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Sunday, September 23, 2007
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