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New Pediatric Labeling Information Database - Detail
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Pediatrics
New Pediatric Labeling Information Database
Detail
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Pediatric Labeling Date:
01/24/2020
Trade Name:
Dificid
Generic Name or Proper Name (*):
fidaxomicin
Indications Studied:
Treatment of Clostridioides difficile-associated diarrhea (CDAD) in pediatric patients 6 months to 17 years
Label Changes Summary:
*Safety and effectiveness of the treatment of CDAD have been established in pediatric patients 6 months to 17 years. *Use of fidaxomicin in these age groups is supported by evidence from adequate and well-controlled trials of fidaxomicin in adults with CDAD and pharmacokinetic, safety and efficacy data from pediatric trials. *Adverse reactions are similar to those observed in adults. *Safety and effectiveness have not been established in pediatric patients younger than 6 months. *Information on dosing, Adverse Reactions, PK parameters and clinical trials. *New oral suspension. *Postmarketing study. *Summary pending.
BPCA(B):
B
Sponsor:
Cubist Pharmaceuticals
Pediatric Exclusivity Granted Date:
12/13/2019
NNPS:
FALSE
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