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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:
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
PREA(P):
P
Sponsor:
Galderma
NNPS:
FALSE'
Therapeutic Category:
Antiacne, topical
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