(PSYCHIATRIC TIMES) - ROCKVILLE, Md., Aug. 22 -- The FDA approved risperidone (Risperdal) today for schizophrenia in adolescents and for bipolar I disorder in pediatric patients as young as 10.
The action marks the first time that the FDA has approved an atypical antipsychotic medication for use in children, said Thomas Laughren, M.D., director of the division of psychiatry products at the FDA's Center for Drug Evaluation and Research.
At a press briefing Dr. Laughren said the FDA was aware that risperidone was already used off-label to treat both conditions in children. Yet, he pointed out that the three trials submitted for approval provided evidence that risperidone is effective in children at doses of 1 to 3 mg and increasing the dose to 3 to 6 mg did not increase efficacy.
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