Bausch Health Responds to Norwich Pharma Tentative FDA Approval for 200 mg Rifaximin

 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.

https://www.biospace.com/article/releases/bausch-health-responds-to-norwich-pharmaceuticals-tentative-fda-approval-for-a-200-mg-rifaximin/