fecal microbiota spores, live-brpk

FDA Drug Profile — VOWST

Drug Details

Generic Name
fecal microbiota spores, live-brpk
Brand Names
VOWST
Application Number
BLA125757
Sponsor
Aimmune Therapeutics, Inc.
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
DONOR HUMAN STOOL SPORES (ETHANOL TREATED)

Indications and Usage

1 INDICATIONS AND USAGE 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). 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). ( 1 ) Limitation of Use: VOWST is not indicated for treatment of CDI. Limitation of Use: VOWST is not indicated for treatment of CDI.