FDA Approves Actavis’s Viberzi, Valeant’s Xifaxan for IBS-D

The Food and Drug Administration May 27 approved Viberzi (eluxadoline) and Xifaxan (rifaximin), two new treatments, manufactured by two different companies, for irritable bowel syndrome with diarrhea (IBS-D) in adult men and women.

Viberzi, which contains a new active ingredient, is taken orally twice daily with food, the agency said. Viberzi is manufactured by Dublin-based Actavis Plc.

Actavis said in a statement on the approval that the FDA has recommended that Viberzi be classified as a controlled substance and this recommendation has been submitted to the Drug Enforcement Administration.

Once Viberzi receives a final scheduling designation, the updated label will ...