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

Supporting Documents

• November 30, 2022 Approval Letter - REBYOTA
• November 30, 2022 Summary Basis for Regulatory Action - REBYOTA