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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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