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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:  06/28/2018
 
Trade Name:  Qbrexza cloth
 
Generic Name or Proper Name (*):  glycopyrronium
 
Indications Studied:  Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
 
Label Changes Summary:  *Safety, effectiveness and pharmacokinetics of Qbrexza have been established in pediatric patients age 9 years and older. *Use in this age group is supported by evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled 4-week trials which included 34 pediatric subjects 9 years and older. *Safety and effectiveness have not been established in pediatric patients less than 9 years of age. *Information on dosing, adverse reactions, clinical trials. *New dosage form.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Dermira, Inc.
 
NNPS:  FALSE
 
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