(risperidone, Janssen)
An atypical antipsychotic for short-term treatment of acute manic or mixed episodes associated with bipolar I disorder, as monotherapy, or in combination with lithium or valproate. Approved in 1994 for schizophrenia.
* Recommended Dosage: Starting at 2-3 mg once daily, reducing or increasing dose by 1 mg/day, no less than 24 hours apart. In short-term trials, from 1- to 6-mg dail…
NEW BRUNSWICK - Johnson & Johnson must supply more data to United States regulators before they can approve a once-monthly schizophrenia treatment to make up for declining sales of the company’s top -selling drug Risperdal.
The request from the Food and Drug Administration didn’t include a demand for additional studies, New Brunswick-based J&J said in a statement last week. The drug, paliperidone palmitate, is one of two monthly medici…
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).
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The Food and Drug Administration has approved the first generic versions of Risperdal (Johnson & Johnson).The agency gave clearance to Teva Pharmaceuticals USA for various product strengths.
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