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Bausch Health Responds to Norwich's ANDA Tentative Approval and Lawsuit Against United States Food and Drug Administration
LAVAL, QC / ACCESSWIRE / June 6, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), and it...
About this update from Bausch Health Companies Inc.
[{"type":"text","content":"Bausch Health Responds to Norwich's ANDA Tentative Approval and Lawsuit Against United States Food and Drug AdministrationLAVAL, QC / ACCESSWIRE / June 6, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, understand that in a June 2, 2023, letter, the U.S. Food and Drug Administration (FDA) granted Norwich Pharmaceuticals Inc. Tentative Approval of its Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg. At the same time, the FDA confirmed in its Letter that it cannot grant Final Approval until Oct. 2, 2029 - the date specified by the presiding judge in his Final Judgment in Salix Pharmaceuticals, LTD et al. v. Norwich Pharmaceuticals, Inc.Having recently failed in its attempt to modify the Final Judgment (see May 17 Press Release), Norwich has now sued the FDA in the United States District Court for the District of Columbia requesting that the Court direct the FDA to immediately grant Final Approval to the ANDA. Like its failed motion for modification of the Final Judgment, Norwich's lawsuit is another attempt to avoid the Final Judgment.Bausch Health intends to intervene in Norwich's lawsuit against the FDA and will continue to take all steps to vigorously defend its intellectual property.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...