Bausch Health Responds to Norwich Pharmaceuticals Tentative FDA Approval for a 200 mg Rifaximin
Bausch Health Companies Inc. (NYSE/TSX: BHC) announced the FDA's tentative approval of Norwich Pharmaceuticals' rifaximin 200 mg product, classified under a Paragraph III filing. The approval will not lead to full authorization until July 24, 2029, when the last of Bausch's patents for XIFAXAN expires. Currently, XIFAXAN contributes less than 1% of Salix's revenues. XIFAXAN is used to treat travelers' diarrhea and has additional indications for major gastrointestinal conditions.
- FDA's tentative approval may set the stage for future market entry of rifaximin.
- XIFAXAN is indicated for gastrointestinal conditions, potentially widening its market appeal.
- Full approval is contingent upon the expiration of patents, limiting immediate revenue potential.
- XIFAXAN currently contributes less than 1% of Salix revenues, indicating limited impact on overall sales.
LAVAL, QC, Sept. 9, 2022 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("the Company"), and its gastroenterology business Salix Pharmaceuticals, today responded to the U.S. Food and Drug Administration's (FDA) tentative approval of the Norwich Pharmaceuticals rifaximin 200 mg product.
The Company understands this was a Paragraph III filing. A Paragraph III filing is made when an Abbreviated New Drug Application (ANDA) applicant does not intend to market its generic product until the patent expiration. The FDA will therefore not grant full approval until the expiry of the last of the Company's Orange Book listed patents for the XIFAXAN® (rifaximin) 200 mg product on July 24, 2029.
XIFAXAN 200 mg is indicated for travelers' diarrhea and currently contributes less than 1 percent of Salix revenues.
XIFAXAN (rifaximin) 200 mg tablets are indicated for travelers' diarrhea.
XIFAXAN (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.
Salix 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.
Bausch 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 gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our approximately
This news release may contain forward-looking statements about the future performance of Bausch Health, which may generally be identified by the use of the words "anticipates," "hopes," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "subject to" and variations or similar expressions, including statements about the Company's intentions to file an appeal with respect to, and take actions to vigorously defend, its intellectual property. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In particular, Bausch Health can offer no assurance as to the timing of any approval by the FDA of any ANDA or amended ANDA and as to the outcome of any appeal. Actual results are subject to other risks and uncertainties that relate more broadly to Bausch Health's overall business, including those more fully described in Bausch Health's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian securities administrators, which factors are incorporated herein by reference.
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