Risperdal (risperidone) is already indicated in adults for the treatment of schizophrenia, manic symptoms of acute manic or mixed episodes associated with bipolar I disorder, and for the treatment of irritability associated with autistic disorder in ages 5-16 years.
The approval means that Risperdal can now be prescribed 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.
J&J said that the 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 US by Janssen and promoted by McNeil Pediatrics, a division of McNeil-PPC.