Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  10/04/2019
 
Trade Name:  Aklief
 
Generic Name or Proper Name (*):  trifarotene
 
Indications Studied:  Acne vulgaris
 
Label Changes Summary:  *Safety and effectiveness for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years to 17 years based on evidence from well-controlled clinical trials, a long-term safety trial, and a pharmacokinetic trial. A total of 897 pediatric subjects aged 9 to 17 years received Aklief Cream in the clinical trials. *Safety and effectiveness have not been established in pediatric subjects under the age of 9 years. *Information on PK parameters and clinical trials.
 
PREA(P):  P
 
Sponsor:  Galderma
 
NNPS:  FALSE
 
Therapeutic Category:  Antiacne, topical
 
-
-