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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:  01/27/2017
 
Trade Name:  Latuda
 
Generic Name or Proper Name (*):  lurasidone hydrochloride
 
Indications Studied:  Treatment of schizophrenia in adolescents and irritability associated with autistic disorder in pediatric patients
 
Label Changes Summary:  Schizophrenia *Safety and effectiveness for the treatment of schizophrenia in adolescents 13 to 17 years was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients. *In the short-term, placebo-controlled adolescent schizophrenia study, somnolence was reported by 14.5% (31/214) of patients treated with Latuda compared to 7.1% (8/112) of placebo patients. *In the short-term, placebo-controlled, study of schizophrenia in adolescents, the incidence of EPS, excluding events related to akathisia, for Latuda-treated patients was higher in the 40 mg (10%) and the 80 mg (7.7%) treatment groups vs. placebo (3.6%); and the incidence of akathisia-related events for Latuda-treated patients was 8.9% vs. 1.8% for placebo-treated patients. *The most common adverse reactions in adolescent patients treated with Latuda were somnolence, nausea, akathisia, extrapyramidal symptoms (non-akathisia, 40mg only), vomiting, and rhinorrhea/rhinitis (80mg only). Irritability Associated with Autistic Disorder *The effectiveness in pediatric patients for the treatment of irritability associated with autistic disorder has not been established. *Efficacy was not demonstrated in a 6-week study of 149 pediatric patients 6 to 17 years with irritability associated with autistic disorder. *Vomiting occurred at a higher rate than reported in other Latuda studies (4/49 or 8% for 20mg, 14/51 or 27% for 60mg, and 2/49 or 4% for placebo), particularly in children ages 6 to 12 (13 out of 18 patients on Latuda with vomiting). *Information on dosing, metabolic changes, adverse reactions and clinical trials. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Sunovion Pharmaceuticals
 
Pediatric Exclusivity Granted Date:  12/20/2016
 
NNPS:  FALSE
 
Therapeutic Category:  Antipsychotic
 
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