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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:  09/27/2016
 
Trade Name:  Avelox
 
Generic Name or Proper Name (*):  moxifloxacin hydrochloride
 
Indications Studied:  Complicated intra-abdominal infections (cIAI)
 
Label Changes Summary:  *Safety and efficacy in pediatric patients for tbe treatment of clAl has not been demonstrated. *Pediatric patients 3 months to <18 years of age (N=451) were enrolled in a single randomized, double blind, active controlled trial in clAl including appendicitis with perforation, abscesses and peritonitis. *Adverse reactions were similar to those observed in adults. *Information on adverse reactions, clinical trial.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Bayer
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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