Proper Name: fecal microbiota spores, live-brpk
Manufacturer: Seres Therapeutics, Inc.
- VOWST is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
- Package Insert - VOWST
- Patient Information - VOWST
- Demographic Subgroup Information – fecal microbiota spores, live-brpk (VOWST)
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.
- April 26, 2023 Summary Basis for Regulatory Action - VOWST
- April 26, 2023 Approval Letter - VOWST
- Approval History, Letters, Reviews, and Related Documents - VOWST