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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
Sponsor:  Pfizer
Therapeutic Category:  Antibiotic