ISSN 0377-9556 (PRINT)
ISSN 2383-9457 (ONLINE)
ISSN 2383-9457 (ONLINE)
FDA approved FMT Products
| Product Name | RebyotaTM | VowstTM |
|---|---|---|
| Applicant | Ferring Pharmaceuticals, Inc. | Seres Therapeutics, Inc |
| Proper Name | fecal microbiota, live-jslm | Fecal Microbiota Spores, Live |
| FDA Approval Date | 2022.11.30 | 2023.04.26 |
| Indication | Prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI | Prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI |
| Limitation of Use | not indicated for treatment of CDI | not indicated for treatment of CDI |
| Dosage Form | Suspension | Capsule |
| Preparation | Prior to use, thaw completely by placing the carton in a refrigerator, 2°C to 8°C(36°F to 46°F), for approximately 24 hours | Prior to taking the first dose (1) Complete antibacterial treatment for rCDI 2 to 4 d before initiating treatment. (2) Drink 296 mL(10 oz) of magnesium citrate on the day before and at least 8 h prior to taking the first dose |
| Single Dose | 150 mL | 4 capsules |
| Storage and handling | Store in the refrigerator at 2 to 8°C (36 to 46°F) and used within 5 days, including thawing time | Store in the original packaging at 2 to 25°C (36 to 77°F) |
| Dosage and Administration | For rectal administration only | 4 capsules taken orally once daily for 3 consecutive days |