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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
 
BPCA(B):  B
 
Sponsor:  Otsuka
 
Pediatric Exclusivity Granted Date:  11/14/2007
 
NNPS:  FALSE'
 
Therapeutic Category:  Antipsychotic
 
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