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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:  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.
Sponsor:  Galderma
Therapeutic Category:  Antiacne, topical