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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:  08/20/2014
 
Trade Name:  Arnuity Ellipta
 
Generic Name or Proper Name (*):  fluticasone furoate
 
Indications Studied:  Maintenance treatment of asthma as prophylactic therapy
 
Label Changes Summary:  Approved for use in adults and pediatric patients 12 years and older Safety and efficacy in pediatric patients younger than 12 years have not been established Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. The growth of children and adolescents receiving orally inhaled corticosteroids, including Arnuity Ellipta, should be monitored routinely. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks associated with alternative therapies Information on safety, adverse events and clinical trials New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiasthmatic
 
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