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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:  12/04/2019
 
Trade Name:  Latuda
 
Generic Name or Proper Name (*):  lurasidone hydrochloride
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *In a long-term, open-label study that enrolled pediatric patients age 6 to 17 years with schizophrenia, bipolar depression, or autistic disorder from three short-term, placebo-controlled trials, 54% (378/701) received lurasidone for 104 weeks. *In this trial, the mean increase in height from open-label baseline to Week 104 was 4.94 cm. The mean change in height z-score indicates a minimal deviation from the normal growth curve. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Sunovion Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antipsychotic
 
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