01:03 PM EST, 01/17/2025 (MT Newswires) -- The U.S. Food and Drug Administration has granted a tentative approval to Amneal Pharmaceutical's generic rifaximin (gXifaxan) 550mg abbreviated new drug application (ANDA). RBC notes this is the third such tentative approval for a generic rifaximin 550 mg ANDA.

RBC analyst Douglas Miehm forecasts a generic Xifaxan for the irritable bowel syndrome with diarrhea (IBS-D) indication to launch in Q4/26 and does not think a generic company would wait for an Appellate Court decision, given the previous Xifaxan patent litigation between Norwich and Bausch Health ( BHC ) in which selected IBS-D patents were invalidated.

Bausch Health ( BHC ) is rated Sector Perform, with a target price of US$11.

Price: 11.00, Change: -0.01, Percent Change: -0.09