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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:  10/29/2007
Trade Name:  Abilify
Generic Name or Proper Name (*):  aripiprazole
Indications Studied:  Schizophrenia
Label Changes Summary:  * Extended schizophrenia indication from adults to adolescents 1317 years * Safety and effectiveness in pediatric patients with bipolar mania or agitation associated with schizophrenia or bipolar mania have not been established * Efficacy for the maintenance treatment of schizophrenia in the pediatric population has not been evaluated * In 6-week placebo controlled efficacy trial in patients 13  17 years with Schizophrenia 30 mg/day was not shown to be more efficacious than 10 mg/day * Common adverse events observed were extrapyramidal disorder, somnolence, and tremor; these 3 AEs appear to have a possible dose response relationship * Information on dose, AEs, clinical studies
Product Labeling:  Labeling  Opens a new window
Sponsor:  Otsuka
Pediatric Exclusivity Granted Date:  11/14/2007
Therapeutic Category:  Antipsychotic