VOWST
STN: 125757
Proper Name: fecal microbiota spores, live-brpk
Tradename: VOWST
Manufacturer: Seres Therapeutics, Inc.
Indication:
- 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).
Product Information
- 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.
Supporting Documents
- April 26, 2023 Summary Basis for Regulatory Action - VOWST
- April 26, 2023 Approval Letter - VOWST
- Approval History, Letters, Reviews, and Related Documents - VOWST