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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:  01/16/2015
 
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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Fougera Pharmaceuticals Inc.
 
Therapeutic Category:  Antiinflammatory, topical
 
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