Proper Name: fecal microbiota, live-jslm
Manufacturer: Ferring Pharmaceuticals Inc.
- 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.
- 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.
- November 30, 2022 Approval Letter - REBYOTA
- November 30, 2022 Summary Basis for Regulatory Action - REBYOTA
- Approval History, Letters, Reviews, and Related Documents - REBYOTA