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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  08/22/2007
 
Trade Name:  Risperdal
 
Generic Name or Proper Name (*):  risperidone
 
Indications Studied:  Schizophrenia; short-term treatment of acute manic or mixed Episodes associated with Bipolar I Disorder
 
Label Changes Summary:  * Extended schizophrenia indication from adults to adolescents 1317 years; extended bipolar mania indication from adults to children and adolescents 10-17 years * Safety and effectiveness in children < 13 years of age with schizophrenia have not been established; safety and effectiveness in children < 10 years of age with bipolar mania have not been established * No additional benefit was seen above 3 mg/day in schizophrenia studies and 2.5 mg/day in the Bipolar mania study; higher doses were associated with more adverse events. Doses higher than 6 mg/day have not been studied. * Information on dose, clinical studies, AE profile
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Johnson & Johnson
 
Pediatric Exclusivity Granted Date:  02/28/2007
 
NNPS:  FALSE
 
Therapeutic Category:  Antipsychotic
 
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