Case Evaluation

Risperdal: Risperdal Approved for Teens with Schizophrenia

Risperdal Approved for Teens with Schizophrenia

June 23, 2007

The United States Food and Drug Administration (FDA) has approved the use of Risperdal (risperidone) for the treatment of adolescents (ages 13-17 years old) with schizophrenia. The FDA is asking for more information about the company's schizophrenia treatment. The company did not specify what the FDA is specifically seeking, but said it did not ask for additional studies. The manufacturer, Johnson & Johnson, will be updating the prescribing information for Risperdal accordingly.

This process of Risperdal approval for teens seems like more of a formality as schizophrenia typically develops in the teen years, and Risperdal has been prescribed for over a decade to these people. To our knowledge, no new studies were done for this new extended approval by the FDA. Most likely additional data was requested from J&J by the FDA for this approval. Other anti-psychotic medications manufacturers like Bristol Myers (makers of Abilify) have also requested approval for use of their medications in teens - and those requests will, we expect, be forthcoming.

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