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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:  05/17/2018
 
Trade Name:  Arnuity Ellipta
 
Generic Name or Proper Name (*):  fluticasone furoate
 
Indications Studied:  Maintenance treatment of asthma in pediatric patients ages 5 through 11 years
 
Label Changes Summary:  *Safety and efficacy of in pediatric patients with asthma aged 5 to 11 years have been established in 3 clinical trials. *In those trials, 234 subjects were administered Arnuity Ellipta 50 mcg once daily. Patients aged 5 to 11 years demonstrated safety and efficacy results similar to those observed in subjects aged 12 years and older. *Safety and efficacy have not been established in pediatric patients aged younger than 5 years. *Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. *Information on dosing, adverse reactions, PK parameters, and clinical trials.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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