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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:  09/19/2006
 
Trade Name:  Verdeso Foam
 
Generic Name or Proper Name (*):  desonide
 
Indications Studied:  Treatment of mild to moderate atopic dermatitis in patients 3 months of age and older
 
Label Changes Summary:  * Effectiveness established from studies in 581 pediatric patients 3 months to 17 years of age * Effect on HPA axis function was investigated in pediatric patients 6 months to 17 years of age in one study of 75 patients * Safety has not been evaluated in patients below 3 months of age * Use for the minimum amount of time necessary due to the potential to suppress HPA axis treatment should not exceed 4 consecutive weeks * New dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Connetics
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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