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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:  12/11/2017
 
Trade Name:  Xepi
 
Generic Name or Proper Name (*):  ozenoxacin
 
Indications Studied:  Impetigo in adults, adolescents and children 2 months and older
 
Label Changes Summary:  *Safety and effectiveness in the treatment of impetigo have been established in pediatric patients 2 months to 17 years of age. *Use in pediatric patients 2 months to 17 years of age is supported by evidence from adequate and well-controlled studies in which 251 pediatric patients received at least one dose of Xepi. *Safety and effectiveness in pediatric patients younger than 2 months of age have not been established. *Information on adverse reactions and clinical trials.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Ferrer Internacional S.A.
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic, topical
 
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