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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:  03/23/2020
Trade Name:  Eucrisa ointment
Generic Name or Proper Name (*):  crisaborole
Indications Studied:  Mild to moderate atopic dermatitis in patients 3 months to less than 2 years
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 3 months and older for topical treatment of mild to moderate atopic dermatitis. *Use in this age group is supported by data from two 28-day, vehicle-controlled safety and efficacy trials which included 1,313 pediatric patients ages 2 years to 17 years whom received Eucrisa. *Use in pediatric patients ages 3 months to less than 2 years was supported by data from a 28-day open-label, safety and pharmacokinetics (PK) trial in 137 patients. *Safety and effectiveness in pediatric patients below the age of 3 months have not been established. *No new safety signals were identified in patients 3 months to less than 2 years. *Information on adverse reactions, PK parameters, and clinical studies. *Postmarketing study.
Sponsor:  Anacor Pharmaceuticals, Inc.
Pediatric Exclusivity Granted Date:  02/21/2020
Therapeutic Category:  Phosphodiesterase 4 inhibitor