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Rifaximin is approved by both the U.S. Food and Drug Administration (FDA) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), though with different labeling scopes.
The FDA first approved rifaximin in May 2015 specifically for IBS with diarrhea (IBS-D) in adults. It is a non-systemic antibiotic that modulates gut microbiota and reduces bacterial overgrowth linked to IBS symptoms. The standard approved dose is 550 mg three times daily for 14 days, with the possibility of repeat treatment courses for recurrent symptoms, as demonstrated in the TARGET 3 phase III trial (1, 3, 4, 5)
Its EU authorizations mainly cove…