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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 indication
Product Labeling:  Labeling  Opens a new window
Sponsor:  Janssen
Therapeutic Category:  Antipsychotic