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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:  06/09/2014
 
Trade Name:  Abilify
 
Generic Name or Proper Name (*):  aripiprazole
 
Indications Studied:  Maintenance treatment of irritability associated with autistic disorder
 
Label Changes Summary:  Efficacy for the maintenance treatment of irritability associated with autistic disorder was not established in a 12 week clinical trial in 85 pediatric patients 6-17 years Information on clinical trialPostmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Otsuka
 
NNPS:  FALSE'
 
Therapeutic Category:  Antipsychotic
 
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