Norwich Fails to Force FDA to OK Copy of Bausch’s Xifaxan (2)

Norwich Pharmaceuticals Inc. lost its bid for a judgment forcing regulatory approval of a copy of Bausch Health Cos.’ Xifaxan 550-milligram tablet, as a federal judge said it “needs a time machine” to achieve the remedy it sought.

Judge Beryl A. Howell also denied Norwich’s request for a hearing and additional arguments because she deemed the existing record sufficient, according to her redacted opinion issued April 18 in the US District Court for the District of Columbia.

Norwich, an Alvogen Group Inc. subsidiary, sued the US Food and Drug Administration in January alleging the decision to grant only tentative approval ...