District court dismisses GI lawsuit against the FDA

The U.S. District Court for the District of Columbia has denied a request from Norwich Pharmaceuticals that would require the FDA to grant immediate final approval of its new drug application for its gastrointestinal medication Xifaxan. 

In 2022, Bausch Health Cos. and its GI business, Salix Pharmaceuticals, filed a lawsuit against Norwich alleging that the company infringed on Bausch's patents for the drug Xifaxan. 

A U.S. District Court of Delaware decision found that some of Bausch's drug patents were infringed and invalid, and the company is currently appealing the decision to the U.S. Court of Appeals for the Federal Circuit.

By denying Norwich's motion, the District Court granted judgment in favor of both the FDA and Salix, according to a Nov. 1 press release. 

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