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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:
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
PREA(P):
P
Sponsor:
Anacor Pharmaceuticals, Inc.
NNPS:
FALSE
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