A Phase 3, Multicenter, Investigator-blind, Randomized, Parallel Group Study to Investigate the Safety and Efficacy of Fidaxomicin Oral Suspension or Tablets Taken q12h, and Vancomycin Oral Liquid or Capsules Taken q6h, for 10 Days in Pediatric Subjects With Clostridium Difficile-associated Diarrhea
Phase of Trial: Phase III
Latest Information Update: 04 Oct 2019
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At a glance
- Drugs Fidaxomicin (Primary) ; Vancomycin
- Indications Clostridium difficile infections; Diarrhoea
- Focus Registrational; Therapeutic Use
- Acronyms SUNSHINE
- Sponsors Astellas Pharma Europe Ltd
- 02 Oct 2019 According to a Merck media release, the Prescription Drug User Fee Act (PDUFA) for both the applications is set for Jan. 24, 2020.
- 02 Oct 2019 According to a Merck media release, based on the data of this study, the US Food and Drug Administration (FDA) has accepted two applications for review 1) a New Drug Application (NDA) for DIFICID (fidaxomicin) for oral suspension, and 2) a supplemental NDA (sNDA) for a new indication for use of DIFICID tablets and oral suspension for the treatment of Clostridium (also known as Clostridioides) difficile infections (CDI) in children aged six months or older.
- 17 Apr 2018 Status changed from active, no longer recruiting to completed.