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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:
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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