FDA clears Risperdal for two new indications
The US Food and Drug Administration has 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. The drug is marketed in the USA by Janssen LP, a Johnson & Johnson company, and promoted is by McNeil Pediatrics, a division of McNeil-PPC.
This approval is based on studies involving more than 430 adolescents, aged 13-17, in the treatment of schizophrenia and 160 children and adolescents, aged 10-17, for the short-term treatment of bipolar mania associated with manic or mixed episodes of bipolar I disorder.
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