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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:
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
PREA(P):
P
Sponsor:
Medicis
NNPS:
FALSE'
Therapeutic Category:
Anti-inflammatory, topical
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