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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:  12/14/2016
 
Trade Name:  Eucrisa ointment
 
Generic Name or Proper Name (*):  crisaborole
 
Indications Studied:  Mild to moderate atopic dermatitis in patients 2 years of age and older
 
Label Changes Summary:  * Safety and effectiveness have been established in pediatric patients age 2 years and older for topical treatment of mild to moderate atopic dermatitis. * Use in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 28-day trials which included 1,313 pediatric patients 2 years and older. *Safety and effectiveness in pediatric patients below the age of 2 years have not been established. * Information on PK, adverse events in adults and children, and clinical trial. *New drug.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Anacor Pharmaceuticals, Inc.
 
NNPS:  FALSE
 
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