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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:  09/10/2019
 
Trade Name:  Aczone Gel
 
Generic Name or Proper Name (*):  dapsone
 
Indications Studied:  Acne vulgaris
 
Label Changes Summary:  *Expanded the patient population to down to 9 years of age and older; previously approved down to 12 years. *Use in patients 9 to 11 years of age for this indication is supported by evidence from adequate and well-controlled clinical trials in 1066 patients 12 years and older and with additional pharmacokinetic and safety data in pediatric patients 9 to 11 years from an open label study of 100 patients with acne. *The adverse reactions in clinical trials was similar to the vehicle control group. *Safety and effectiveness have not been established in pediatric patients below 9 years of age. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  Almirall, LLC
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
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