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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Otsuka
NNPS:
FALSE'
Therapeutic Category:
Antipsychotic
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