LAVAL, QC / ACCESSWIRE / April 11, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced that its topical prescription treatment for acne vulgaris, PrARAZLOTM (tazarotene lotion, 0.045% w/w), is now available to patients through BC PharmaCare, the public drug program of British Columbia.
LAVAL, QC / ACCESSWIRE / April 11, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), and its gastroenterology business Salix Pharmaceuticals, today announced that the U.S. Court of Appeals for the Federal Circuit in the matter of Salix Pharmaceuticals, LTD. et al v. Norwich Pharmaceuticals, Inc., affirmed the May 17, 2023 decision of the U.S. District Court for the District of Delaware that had denied Norwich Pharmaceuticals, Inc.'s motion for modification of the court's final order preventing the U.S. Food and Drug Administration (FDA) from approving its abbreviated new drug application (ANDA) for XIFAXAN (rifaximin) 550 mg before Oct. 2, 2029. The Court of Appeals also affirmed the August 10, 2022 decision of the District Court that invalidated certain U.S. Patents protecting the composition and use of XIFAXAN® for treating IBS-D. As a result of the Federal Circuit's decision, Norwich's abbreviated new drug application for XIFAXAN (rifaximin) 550 mg remains barred from approval by the U.S. Food and Drug Administration until Oct. 2, 2029.
LAVAL, QC / ACCESSWIRE / April 11, 2024 / Bausch Health Companies Inc. (NYSE:NHC)(TSX:BHC) will release first-quarter 2024 financial results on Thursday, May 2, 2024. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call.
LAVAL, QC / ACCESSWIRE / April 5, 2024 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) along with its gastroenterology business, Salix Pharmaceuticals, Inc., announced that it filed a lawsuit today in the United States District Court for the District of New Jersey against Amneal Pharmaceuticals of New York, LLC, Amneal EU, Limited, Amneal Pharmaceuticals, LLC, Amneal Pharmaceuticals Private Limited, and Amneal Pharmaceuticals, Inc. This lawsuit follows receipt of a Notice of Paragraph IV Certification stating that Amneal submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of XIFAXAN® (rifaximin) 550 mg tablets. Amneal asserts that certain patents listed in the FDA's Orange Book for XIFAXAN® are unenforceable, invalid, and/or not infringed by Amneal's ANDA product. This action formally initiates the litigation process under the Hatch-Waxman Act and triggers a 30-month stay of any potential FDA approval for Amneal's ANDA.
LAVAL, QC / ACCESSWIRE / April 3, 2024 / Bausch Health, Canada Inc., part of Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC), today announced the first public drug plan listings for PrUCERIS® (budesonide) aerosol foam to treat mild to moderate distal ulcerative colitis in adults.1
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