The approval was based on data from three Phase III studies, TARGET 1, TARGET 2 and TARGET 3 involving more than 3,000 patients.
In these trials, Xifaxan 550mg showed the efficacy and safety of repeat treatment following completion of a two-week course of treatment.
Digestive Disease National Coalition (DDNC) president and member of the Board of Directors Dr Costas Kefalas said: "The Xifaxan 550mg approval gives patients access to a treatment that may alleviate their symptoms.
"This treatment is in line with the DDNC’s mission to provide improved access to quality digestive health care."
Data from TARGET 1 and 2 showed patients treated with Xifaxan 550mg achieved relief of the FDA composite endpoint versus placebo, while TARGET 3 showed that patients who responded to treatment with this drug but experienced recurrent symptoms responded to repeat treatment in the FDA composite endpoint versus placebo.
The company has also secured approval for Xifaxan 550mg for the management of hepatic encephalopathy.