Norwich Bruised As Failed US Rifaximin Appeal Bars Approval Until 2029
Sandoz, Teva Among Settled ANDA Sponsors; Xifaxan Brand Worth $1.6bn Annually
Norwich Pharmaceuticals looks set for a five-year wait to launch its generic version of Bausch Health’s core Xifaxan, after the Federal Circuit shot down its appeal to a bar on US FDA approval. The generics manufacturer has previously sought to supercharge its approval by carving a patent-protected indication from the label.