Bausch Health announced that the U.S. District Court for the District of Columbia in the matter of Norwich Pharmaceuticals versus Becerra denied Norwich’s motion in its 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. The district court denied Norwich’s motion and granted summary judgment in favor of the FDA and Bausch Health’s Salix, the company said in a statement. “The Company is pleased with this outcome at the District Court. Its appeal of the final judgment in the matter of Salix Pharmaceuticals, Ltd. et al. v. Norwich Pharmaceuticals, Inc. 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,” it added.
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