FDA Says Norwich Lacks Standing in Clash Over Xifaxan Copy

The US Food and Drug Administration urged a federal judge to reject Norwich Pharmaceuticals Inc.’s bid to force regulatory approval of a Xifaxan copy carving a patent-infringing use from the generic’s label while their case continues, calling the “collateral attack” on another court’s judgment “as extraordinary as it is baseless.”

“Norwich lacks standing because its present inability to market rifaximin”—the active ingredient in Bausch Health Cos.’ blockbuster drug—"is traceable to the Delaware Court’s Patent Orders and not FDA,” according to a combined opposition to Norwich’s motion for a preliminary injunction and for summary judgment, filed Wednesday in the US District ...