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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:  11/25/2013
 
Trade Name:  Noxafil
 
Generic Name or Proper Name (*):  posaconazole
 
Indications Studied:  Prophylaxis of invasive Aspergillus and Candida infections in high risk patients
 
Label Changes Summary:  *Safety and effectiveness have been established in pediatric patients 13 - 17 years. Use is supported by evidence from adequate and well-controlled studies in adults. PK and safety in pediatric patients 13 - 17 years were also assessed and are similar to adults.* Safety and effectiveness in pediatric patients less than 13 years have not been established* Information on dosing, PK, and clinical trials
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
NNPS:  FALSE
 
Therapeutic Category:  Antifungal
 
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