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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:  03/05/2018
 
Trade Name:  Latuda
 
Generic Name or Proper Name (*):  lurasidone hydrochloride
 
Indications Studied:  Treatment of children and adolescents with major depressive episodes associated with bipolar I disorder
 
Label Changes Summary:  *Safety and effectiveness for the treatment of bipolar depression in pediatric patients 10 to 17 years was established in a 6-week, placebo-controlled clinical study in 347 pediatric patients. *Safety and effectiveness have not been established in pediatric patients less than 10 years of age with bipolar depression. *In the 6-week, placebo-controlled bipolar depression study in pediatric patients 10 to 17 years, somnolence was reported by 11.4% (20/175) of patients treated with Latuda compared to 5.8% (10/172) of placebo treated patients. *Information on dosing, adverse reactions, and clinical trial. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Sunovion Pharmaceuticals
 
NNPS:  FALSE
 
Therapeutic Category:  Antipsychotic
 
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