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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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