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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:  09/09/2016
 
Trade Name:  Noxafil
 
Generic Name or Proper Name (*):  posaconazole
 
Indications Studied:  Postmarketing study
 
Label Changes Summary:  *In a study of 136 neutropenic pediatric patients 11 months to less than 18 years treated with posaconazole oral suspension, the exposure was attained in approximately 50% of patients instead of the pre-specified 90% of patients. *Postmarketing study.
 
BPCA(B) and PREA(P):  B,P
 
Sponsor:  Merck
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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