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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:  05/12/2005
 
Trade Name:  Zyvox
 
Generic Name or Proper Name (*):  linezolid
 
Indications Studied:  Central nervous system infections
 
Label Changes Summary:  * PK data in pediatric patients with ventriculoperitoneal shunts showed variable cerebrospinal fluid (CSF) concentrations; therapeutic concentrations were not consistently achieved or maintained in the CSF * Use of linezolid for the empiric treatment of pediatric patients with central nervous system infections is not recommended * Additional information on efficacy in pediatric patients with infectious vancomycin-resistant Enterococcus faecium
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Pfizer
 
Pediatric Exclusivity Granted Date:  02/11/2005
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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