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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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