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New Pediatric Labeling Information Database - Detail
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Pediatrics
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.
PREA(P):
P
Sponsor:
Galderma
NNPS:
FALSE
Therapeutic Category:
Antiacne, topical
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