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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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