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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:  ArmonAir RespiClick
 
Generic Name or Proper Name (*):  fluticasone propionate
 
Indications Studied:  Maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older
 
Label Changes Summary:  *Approved for use in 12 years and older. *Safety and effectiveness in pediatric patients below the age of 12 years have not been established. *Inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity in adolescents. *Information on dosing, and adverse reactions and clinical trials in adults and pediatric patients 12 years and older. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Teva
 
NNPS:  FALSE
 
Therapeutic Category:  Antiasthmatic
 
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