FDA grants tentative approval for Amneal generic of Bausch Health's Xiafan

 

• The U.S. FDA has granted tentative approval to an abbreviated new drug application from Amneal Pharmaceuticals (NASDAQ:AMRX) for a generic of Bausch Health's Xifaxan (rifaximin).
• The drug is indicated for reduction in risk of overt hepatic encephalopathy recurrence in adults and irritable bowel syndrome with diarrhea.
• The agency previously granted tentative ANDA approvals for rifaximin to Sandoz and Norwich Pharmaceuticals.
• In April 2024, Bausch sued Amneal to prevent the launch of its version of rifaximin.
• Bausch has also filed a patent infringement suit against Norwich.

https://www.msn.com/en-us/health/other/fda-grants-tentative-approval-for-amneal-generic-of-bausch-health-s-xiafan/ar-AA1xkEFx