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U.S. District Court Dismisses Norwich's Lawsuit Against the FDA
LAVAL, QC / ACCESSWIRE / November 1, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), an...
About this update from Bausch Health Companies Inc.
[{"type":"text","content":"U.S. District Court Dismisses Norwich's Lawsuit Against the FDA LAVAL, QC / ACCESSWIRE / November 1, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, Inc., today announced that the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals, Inc. v. Becerra, et al. (Case No. 23-cv-01611), denied Norwich Pharmaceuticals, Inc.'s (Norwich) motion in their lawsuit against the U.S. Food and Drug Administration (FDA). Norwich had asked the District Court to direct the FDA to immediately grant Final Approval to Norwich's Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg.Today, the District Court denied Norwich's motion and granted summary judgment in favor of the FDA and Salix.The Company is pleased with this outcome at the District Court. Its appeal of the final judgment in the matter of Salix Pharmaceuticals, Ltd. et al. v. Norwich Pharmaceuticals, Inc. (Case No. No. 22-2153) remains pending at the U.S. Court of Appeals for the Federal Circuit. The Company expects a decision on the appeal from the Federal Circuit in Q1 2024.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 Bridgewater, New Jersey. For more information about Salix, visit www.Salix.com and connect with us on Twitter and LinkedIn.About Bausch HealthBausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in...