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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:  03/02/2006
 
Trade Name:  Vanos Cream
 
Generic Name or Proper Name (*):  fluocinonide
 
Indications Studied:  Relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in children 12 years of age and older
 
Label Changes Summary:  Use in pediatric patients younger than 12 years of age is not recommended Effectiveness extrapolated from adult studies Safety in patients 12 to 17 years of age was similar to that observed in adults Information provided on HPA axis suppression from safety studies with Vanos Cream in 4 cohorts of pediatric patients (3 months - 18 years of age) with atopic dermatitis Studies waived in children 0-11 years of age New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Medicis
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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