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LAVAL, QC / ACCESS Newswire / April 17, 2025 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) (the "Company" or "Bausch Health"), and its gastroenterology business Salix Pharmaceuticals, Inc., today announced the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals, Inc. v. Kennedy, et al. (Case No. 25-cv- 00091), denied Norwich's motion for a preliminary injunction treated as a motion for summary judgment in its lawsuit against the U.S. Food and Drug Administration (FDA).
Norwich had asked the District Court for a judgment declaring the FDA's decision to issue tentative approval for Norwich's Abbreviated New Drug Application (ANDA) for XIFAXAN® (rifaximin) 550 mg and failure to determine Teva Pharmaceuticals USA, Inc. (Teva) had forfeited its 180-day exclusivity were arbitrary, capricious, and contrary to law. Norwich sought an injunction directing the FDA to immediately grant Final Approval to Norwich's ANDA for XIFAXAN® (rifaximin) 550 mg. Norwich argued that if upheld, FDA's determination will prohibit Norwich from marketing those products until at least June 29, 2028, assuming Teva launches its rifaximin product in January 2028.
Today, the District Court denied Norwich's motion and granted summary judgment in favor of the FDA, Salix, and Teva, and closed the case.
"We are pleased with the ruling issued today by the U.S. District Court. We will persist in advocating for the well-being of patients who have greatly benefited from sustained access to XIFAXAN," said Thomas J. Appio, CEO of Bausch Health.
Management will release first quarter financial results after market close on Wednesday, April 30, 2025, followed by a conference call and live webcast at 5:00 p.m. U.S. EDT to discuss results and provide a business update.
About Bausch Health
Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), is a global, diversified pharmaceutical company enriching lives through our relentless drive to deliver better health care outcomes. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, dentistry, aesthetics, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb Corporation. Our ambition is to be a globally integrated healthcare company, trusted and valued by patients, HCPs, employees and investors. For more information about Bausch Health, visit www.bauschhealth.com and connect with us on LinkedIn.
Forward-looking Statements
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