The US Food and Drug Administration (FDA) approved Risperdal (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 US by Janssen, L.P. and promoted by McNeil Pediatrics, a division of McNeil-PPC., Inc. Janssen is the only US pharmaceutical company exclusively dedicated to mental health.

Risperdal (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.