Chain Drug Review - New uses for Risperdal
WASHINGTON — The Food and Drug Administration has approved Risperdal for two psychiatric conditions in children and adolescents.
Janssen L.P., a unit of Johnson & Johnson, received regulatory clearance for the product to treat schizophrenia (ages 13 to 17) and for the short-term treatment of manic or mixed episodes of bipolar I disorder (ages 10 to 17).
This is the first FDA approval of an atypical antipsychotic drug to treat either condition in these age groups.
“Pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose and safety of using this product in the pediatric population,” points out Dianne Murphy, director of the agency’s office of pediatric therapeutics.
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“These data have permitted the identification of the effective pediatric dose ranges and have provided an evidence-based approach for treating these disorders in pediatric patients,” she says.
The FDA initially approved Risperdal fourteen years ago for the treatment of schizophrenia in the adult population.
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