U.S. District Court dismisses Norwich’s lawsuit against the FDA over generic Xifaxan

Bausch Health, and its gastroenterology business Salix Pharmaceuticals announced that the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals v. Becerra, et al. (Case No. 23-cv-01611), denied Norwich’s motion in their lawsuit against the Food and Drug Administration. 

Norwich had asked the District Court to direct the FDA to immediately grant final approval to Norwich's Abbreviated New Drug Application for Xifaxan (rifaximin) 550 mg.

The District Court denied Norwich's motion and granted summary judgment in favor of the FDA and Salix.

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The company said it is pleased with this outcome at the District Court. Its appeal of the final judgment in the matter of Salix Pharmaceutical et al. v. Norwich Pharmaceuticals (Case No. No. 22-2153) remains pending at the U.S. Court of Appeals for the Federal Circuit. The company expects a decision on the appeal from the Federal Circuit in Q1 2024.

Xifaxan (rifaximin) 550 mg tablets are indicated for the reduction in the risk of overt hepatic encephalopathy recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea in adults.