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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:  09/15/2006
 
Trade Name:  Noxafil Oral Suspension
 
Generic Name or Proper Name (*):  posaconazole
 
Indications Studied:  Prevention of invasive Aspergillis and Candida infections in patients 13 years of age and older
 
Label Changes Summary:  * Information on PK and safety studies in patients 13-17 years of age * Safety profile in patients 8-17 years of age similar to adults * Safety and effectiveness in patients below 13 years of age have not been established * Additional information on pharmacokinetics provided in patients down to 8 years of age * Studies deferred in children 0-12 years of age * New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal
 
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