Bausch Health Comments On Tentative FDA Approval Of Generic Version Of Antibiotic Xifaxan

Bausch Health Companies Inc. (BHC) and its gastroenterology business Salix Pharmaceuticals, on Friday said that a generic version to their oral antibiotic Xifaxan 200 mg will not be allowed to enter the market until the patent expires on July 24, 2029.

Xifaxan in 200 mg dosage is indicated for travelers' diarrhea while Xifaxan in 550 mg dosage is 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.

Norwich Pharmaceuticals' generic version of Xifaxan 200 mg was given tentative approval by the FDA as recently as Sep.2, 2022.

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