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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:  04/30/2015
 
Trade Name:  Breo Ellipta
 
Generic Name or Proper Name (*):  fluticasone furoate/vilanterol
 
Indications Studied:  Treatment of asthma
 
Label Changes Summary:  *Breo Ellipta is not indicated for use in children and adolescents. *The efficacy of Breo Ellipta was evaluated in 4 randomized, double-blind, parallel-group clinical trials in adolescent and adult patients with asthma. Adolescents aged 12 to 17 years made up 14% of the study population (n = 281). *Among the adolescents, asthma-related hospitalizations occurred in 4 patients (2.6%) treated with Breo Ellipta 100/25 compared with 0 patients treated with fluticasone furoate 100 mcg. There were no asthma-related deaths or asthma-related intubations observed in the adolescent age group. *Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. *Information on clinical trials in adults and adolescents.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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