Business
Bausch Health Announces Updates Related to Norwich XIFAXAN Matters
LAVAL, QC / ACCESSWIRE / May 14, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its...
About this update from Bausch Health Companies Inc.
[{"type":"text","content":"Bausch Health Announces Updates Related to Norwich XIFAXAN MattersLAVAL, QC / ACCESSWIRE / May 14, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business Salix Pharmaceuticals, today announced certain updates related to its litigation with Norwich Pharmaceuticals, Inc.With respect to the April 11, 2024, decision of the US Court of Appeals for the Federal Circuit, both Bausch Health and Norwich have filed petitions for panel rehearing or rehearing en banc. The Company anticipates a decision on whether a rehearing will be granted within the next three months.The Company has also received notice of a new Paragraph IV certification (the \"Notice\"), dated May 10, 2024, from Norwich advising that it has submitted to the U.S. Food and Drug Administration (FDA) an amendment to an Abbreviated New Drug Application (ANDA) requesting approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets for the treatment of irritable bowel syndrome with diarrhea in adults.Bausch Health is reviewing the Notice and has 45 days from receipt of the Notice to commence a patent infringement lawsuit against Norwich. Bausch Health understands that such a lawsuit would automatically preclude the FDA from approving Norwich's ANDA for up to 30 months or until the issuance of a decision by the district court in this matter that is adverse to Bausch Health, whichever occurs first.Bausch Health intends to vigorously enforce its intellectual property rights relating to XIFAXAN®.About XIFAXANXIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.About SalixSalix Pharmaceuticals is one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases. For more than 30 years, Salix has licensed, developed and marketed innovative products to improve patients' lives and arm health care providers with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to U.S. health care providers through an expanded sales force that focuses on gastroenterology, hepatology, pain specialists and primary care. Salix is headquartered in Bridg...