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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:  10/06/2006
 
Trade Name:  Risperdal Tablets Risperdal Oral Solution Risperdal M-Tabs
 
Generic Name or Proper Name (*):  risperidone
 
Indications Studied:  Treatment of irritability associated with autistic disorder in children 5 years of age and older
 
Label Changes Summary:  Effectiveness and safety established based on two 8 week studies in patients 5-16 years of age and one long-term study of 4-6 months Studies waived in children under 2 years of age due to difficulty to diagnose and treat this population New indicatiContraindicated in infants, small children, or any child who may be unable to swallow a capsule. Dosing information provided Information to monitor disease provided No clinical studies submitted New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Janssen
 
NNPS:  FALSE'
 
Therapeutic Category:  Antipsychotic
 
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