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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:  01/15/2004
 
Trade Name:  Zithromax Tablets
 
Generic Name or Proper Name (*):  azithromycin
 
Indications Studied:  Treatment of acute bacterial sinusitis (sinus infection) in patients 6 months of age and older
 
Label Changes Summary:  Effectiveness extrapolated from adult sinusitis studies and from pediatric acute otitis media studies Clinical studies conducted in pediatric patients 3 years to 16 years of age to determine PK and safety for oral suspension Safety and effectiveness in patients under 6 months of age have not been established Side effects seen in pediatric patients were comparable to those seen in adults, with different incidence rates for the dosage regimens recommended in pediatric patients Dosing regimen established Partial waiver < 6 months of age because too few patients to study New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Pfizer
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic
 
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