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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:  10/08/2008
 
Trade Name:  Zmax Oral Susp
 
Generic Name or Proper Name (*):  azithromycin
 
Indications Studied:  Community-Acquired Pneumonia
 
Label Changes Summary:  Safety and effectiveness established in pediatric patients 6 months of age or older with community-acquired pneumonia. Use is supported by evidence from studies in adults with additional safety and PK data in pediatric patients Safety and effectiveness in the treatment of pediatric patients < 6 months of age have not been established. Safety and effectiveness in the treatment of pediatric patients with acute bacterial sinusitis have not been established Information on dose, PK parameters, AE profile, lab abnormalities, and clinical studies New indication
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Pfizer
 
NNPS:  TRUE'
 
Therapeutic Category:  Antibiotic
 
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