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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:  12/19/2002
 
Trade Name:  Zyvox
 
Generic Name or Proper Name (*):  linezolid
 
Indications Studied:  Nosocomial pneumonia, community-acquired pneumonia, complicated and uncomplicated skin and skin structure infections, and vancomycin-resistant infections caused by susceptible strains
 
Label Changes Summary:  * Extended age range down to birth for nosocomial pneumonia, community-acquired pneumonia, complicated skin and skin structure infections and vancomycin-resistant infections. Safety and efficacy extrapolated from studies in adults and supported by PK and comparator-controlled studies in patients from birth to 11 years * Extended age range down to 5 years of age for uncomplicated skin and skin structure infections based upon a comparator-controlled study in 5 to 17 year olds * Clearance of linezolid varies as a function of age; As age of pediatric patients increases, clearance gradually decreases, and by adolescence mean clearance values approach those observed in adults * Pediatric patients exhibit wider variability in clearance and systemic exposure (AUC) compared with adults * New every 8 hours dosing regimen for pediatric patients birth to 11 years of age and every 12 hours dosing regimen for pediatric patients 12 years and older * Information on PK parameters, AE profile, laboratory changes, dosing, and clinical studies
 
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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