New FDA Approvals

FDA has approved new indications for Janssen's risperidone (Risperdal®) for treating schizophrenia in adolescents ages 13-17 and for the short-term treatment of manic or mixed episodes of bipolar 1 disorder in children and adolescents ages 10-17. This was the first FDA approval of an atypical antipsychotic to treat either disorder in these age groups.

Until now, there has been no FDA-approved drug for treating schizophrenia for pediatric use, and only lithium is approved for treating bipolar disorder in adolescents ages 12 and older.

FDA first approved risperidone in 1993 for treating schizophrenia in adults. It later was approved for short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults and treatment of irritability associated with autistic disorder in children and adolescents age 5-16 years.

Evidence to support the latest approval was collected through studies FDA requested as part of its pediatric drug development initiatives.