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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:  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.
Sponsor:  Cubist Pharmaceuticals
Pediatric Exclusivity Granted Date:  12/13/2019