Bausch Health Responds to Norwich Pharmaceuticals Analyst’s FDA Response to 200 Mg Rifaximin


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LAVAL, QC, September 9, 2022 /PRNewswire/ — Bausch Health Companies, Inc. 200 mg product.

The Company understands that this is an Article III filing. An Article III file is an Abbreviated New Drug Application (ANDA) if the applicant does not intend to commercialize the generic product until the patent expires. Therefore, the FDA will not grant full approval to the company’s Orange Book patent applications for the XIFAXAN® (rifaximin) 200 mg product until the deadline has passed. July 24, 2029.

XIFAXAN 200 mg is known for traveler’s diarrhea and currently contributes less than 1 percent of Salix’s revenue.


XIFAXAN (rifaximin) 200 mg tablets are indicated for traveler’s diarrhea.
XIFAXAN (rifaximin) 550 mg tablets are prescribed to reduce the risk of recurrence of overt hepatic encephalopathy (HE) in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

About Salix

Salix Pharmaceuticals is one of the world’s leading specialty pharmaceutical companies dedicated to the prevention and treatment of gastrointestinal disorders. For more than 30 years, Salix has licensed, developed and commercialized innovative products to improve patients’ lives and equip them with life-changing solutions for many chronic and debilitating conditions. Salix currently markets its product line to US healthcare providers through an expanded sales force focused on gastroenterology, hepatology, pain specialties and primary care. Salix is ​​in the headquarters. Bridgewater, New Jersey. For more information about Salix, visit And connect with us on Twitter and LinkedIn.

About Bausch health

Bausch Health Companies Inc. We, 90% owned by Bausch + Lomb Corporation, develop, manufacture and market a variety of products primarily in the fields of gastroenterology, hepatology, neurology, dermatology, global pharmaceuticals and eye health. With our leading sustainable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit And connect with us Twitter And LinkedIn.

Forward-looking statements

This news release may contain forward-looking statements about Bausch Health’s future performance, which are generally identified by the use of the words “expects,” “expects,” “expects,” “intends,” “plans,” “may,” “could.” may” “believes” “applies” and variations or similar statements, including statements about the Company’s intention to file an appeal, and will take steps to vigorously defend it. Intellectual Property Registration. These statements are based on management’s current expectations and beliefs and may include forward-looking statements. Actual results are subject to certain risks and uncertainties that may differ materially from those expressed. In particular, Bausch Health makes no assurances regarding the timing of FDA approval of any ANDA or any amended ANDA and the outcome of any appeal. Actual results are subject to other risks and uncertainties associated with Bausch Health’s overall business. , including those detailed in Bausch Health’s most recent annual report on Form 10-K and in other filings from time to time by Bausch Health with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which conditions are incorporated by reference.

Source Bausch Health Companies Inc.


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