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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:  02/20/2018
 
Trade Name:  Luzu cream
 
Generic Name or Proper Name (*):  luliconazole
 
Indications Studied:  Tinea pedis and tinea cruris
 
Label Changes Summary:  *Safety and effectiveness in pediatric patients 12 to <18 years with tinea pedis and tinea cruris have been established by evidence from well-controlled trials in adult and pediatric patients and a pharmacokinetic study in pediatric patients. *Safety and effectiveness in pediatric patients 2 to <18 years of age with tinea corporis have been established by evidence from a well-controlled trial in pediatric patients. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Medicis
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal, topical
 
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