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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:  05/01/2003
 
Trade Name:  Flonase Nasal Spray & Cultivate Ointment
 
Generic Name or Proper Name (*):  fluticasone
 
Indications Studied:  Flonase - nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis Cutivate Ointment - corticosteroid-responsive dermatoses
 
Label Changes Summary:  Flonase * New data from 1-year placebo-controlled clinical growth study in pediatric patients 3-9 years of age; no statistically significant effect on growth was noted compared to placebo. No evidence of clinically relevant changes in HPA axis function or bone mineral density was observed as assessed by 12-hour urinary cortisol excretion and dual-energy x-ray absorptiometry, respectively. Cutivate * Indicated for use only in adult patients * In a study of 35 pediatric patients treated for atopic dermatitis, subnormal adrenal function was observed with cosyntropin stimulation testing
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  02/25/2003
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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