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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:  02/24/2016
 
Trade Name:  Aczone Gel 7.5%
 
Generic Name or Proper Name (*):  dapsone
 
Indications Studied:  Treatment of acne vulgaris in patients 12 years of age and older
 
Label Changes Summary:  * Approved in adults and pediatric patients 12 years and older. * Safety and efficacy was evaluated in 1066 patients 12-17 years old. * Safety and effectiveness have not been established in pediatric patients below the age of 12 years. * Safety was similar to the vehicle control group. * Information on clinical trials, and adverse reactions in adults and pediatric patients 12 and older. * New Drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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