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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:  02/27/2008
 
Trade Name:  Abilify
 
Generic Name or Proper Name (*):  aripiprazole
 
Indications Studied:  Bipolar I Disorder
 
Label Changes Summary:  Extended treatment of acute Bipolar Disorder indication from adults to pediatrics 1017 years The efficacy for the maintenance treatment of Bipolar Disorder in the pediatric population has not been evaluated The recommended target dose in Bipolar Disorder is 10 mg/day. In the study of pediatric patients 10  17 years with Bipolar Mania, 4 common adverse reactions had a possible dose response relationship at 4 weeks; extrapyramidal disorder, somnolence, akathisia and salivary hypersecretion Information on dose, AEs, clinical studies
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  Otsuka
 
Pediatric Exclusivity Granted Date:  11/14/2007
 
NNPS:  FALSE'
 
Therapeutic Category:  Antipsychotic
 
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