REBYOTA
STN: 125739
Proper Name: fecal microbiota, live-jslm
Tradename: REBYOTA
Manufacturer: Ferring Pharmaceuticals Inc.
Indication:
- REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older, following antibiotic treatment for recurrent CDI.
Product Information
- Package Insert - REBYOTA
- Demographic Subgroup Information – fecal microbiota, live-jslm (REBYOTA)
Refer to Section 1.1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of demographic subgroup outcomes that is notable.
Supporting Documents
- November 30, 2022 Approval Letter - REBYOTA
- November 30, 2022 Summary Basis for Regulatory Action - REBYOTA
- Approval History, Letters, Reviews, and Related Documents - REBYOTA