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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:  02/01/2013
 
Trade Name:  Epiduo
 
Generic Name or Proper Name (*):  adapalene and benzoyl peroxide
 
Indications Studied:  Treatment of acne vulgaris
 
Label Changes Summary:  Expanded age range down to 9 years; previously approved in pediatric patients 12 years and olderSafety and effectiveness in pediatric patients < 9 years have not been establishedAdverse reactions were similar to those observed in adultsInformation on clinical trialPostmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Galderma
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiacne, topical
 
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