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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:
01/16/2015
Trade Name:
Cutivate
Generic Name or Proper Name (*):
fluticasone propionate
Indications Studied:
Atopic dermatitis
Label Changes Summary:
*Extended the use of Cutivate from patients aged 1 year and older down to 3 months and older *Reversible Hypothalamic-Pituitary-Adrenal (HPA) axis suppression in 1 patient under 1 year *The safety and effectiveness of Cutivate Lotion in pediatric patients below 3 months of age have not been established
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Fougera Pharmaceuticals Inc.
Therapeutic Category:
Antiinflammatory, topical
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