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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:  12/18/2019
Trade Name:  Aralzo
Generic Name or Proper Name (*):  tazarotene
Indications Studied:  Acne
Label Changes Summary:  *Safety and effectiveness for the topical treatment of acne vulgaris have been established in pediatric patients age 9 years and older based on evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 12-week clinical trials and an open-label pharmacokinetic study. *A total of 300 pediatric subjects aged 9 to less than 17 years received Arazlo in the clinical studies. *Safety and effectiveness in pediatric patients below the age of 9 years have not been established. *New dosage form.
Sponsor:  Bausch Health US, LLC
Therapeutic Category:  Antiacne, topical