US approves drug for two pediatric mental disorders
Key points
- Johnson & Johnson won U.S. approval to promote its drug, Risperdal, for two psychiatric conditions in children, U.S. health officials said on Wednesday.
- The Food and Drug Administration said it cleared Risperdal for treating schizophrenia in adolescents ages 13 to 17 and for the short-term treatment of manic or mixed episodes of bipolar disorder in ages 10 to 17.
- The drug is the first atypical antipsychotic drug approved to treat either disorder in those age groups, the FDA said.
- Risperdal already is sold for treating schizophrenia and acute bipolar episodes in adults, as well as irritability associated with autism in children ages 5 to 16.
Johnson & Johnson won U.S. approval to promote its drug, Risperdal, for two psychiatric conditions in children, U.S. health officials said on Wednesday.
The Food and Drug Administration said it cleared Risperdal for treating schizophrenia in adolescents ages 13 to 17 and for the short-term treatment of manic or mixed episodes of bipolar disorder in ages 10 to 17.
The drug is the first atypical antipsychotic drug approved to treat either disorder in those age groups, the FDA said.
Risperdal already is sold for treating schizophrenia and acute bipolar episodes in adults, as well as irritability associated with autism in children ages 5 to 16.
J&J currently reaps global annual sales of more than $4 billion from Risperdal and a newer treatment called Invega that is derived from the active ingredient of Risperdal.
(Reporting by Lisa Richwine)
Written and revised by
David Cohen, M.D.
Our doctors write and review articles for accuracy and keep them up to date.
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