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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 older*Safety and effectiveness in pediatric patients < 9 years have not been established*Adverse reactions were similar to those observed in adults*Information on clinical trial*Postmarketing study
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Galderma
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
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