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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
GlaxoSmithKline
Pediatric Exclusivity Granted Date:
02/25/2003
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, topical
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