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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:  07/15/2015
 
Trade Name:  Epiduo Forte
 
Generic Name or Proper Name (*):  adapalene and benzoyl peroxide
 
Indications Studied:  Treatment of acne vulgaris in patients 12 years and older
 
Label Changes Summary:  *New higher strength combination formulation approved in adults and patients 12 years and older. *Safety and effectiveness in pediatric patients under the age of 12 have not been established. *Information on PK, adverse reactions, and clinical trial in adults and pediatric patients. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Galderma
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
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