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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:  11/19/2009
Trade Name:  Abilify
Generic Name or Proper Name (*):  aripiprazole
Indications Studied:  Irritability associated with autistic disorder
Label Changes Summary:  * Safety and effectiveness in pediatric patients demonstrating irritability associated with autistic disorder were established in two placebo-controlled clinical trials in pediatric patients 6 - 17 years of age * Most common adverse reactions observed in pediatric clinical trials in patients with autistic disorder included sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy. Fatigue was a possible dose-response adverse reaction. * Information on dosing, adverse reactions, and clinical studies
Product Labeling:  Labeling  Opens a new window
Sponsor:  Otsuka
Therapeutic Category:  Antipsychotic