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REBYOTA is indicated for the prevention of recurrence of Clostridioides difficile infection (CDI).
December 1, 2022
By: Kristin Brooks
Managing Editor, Contract Pharma
Ferring Pharmaceuticals received approval from the U.S. FDA for REBYOTA (fecal microbiota, live-jslm), a novel first-in-class microbiota-based live biotherapeutic 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. The approval is based on results from the clinical program including the Phase 3 PUNCH CD3 trial in which a single dose of REBYOTA demonstrated superiorit...
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