Alvogen Loses Bid to Force FDA to Approve Xifaxan Copy Carve-Out

Norwich Pharmaceuticals Inc. lost one front of its courtroom quest to force US regulatory approval of a generic version of Bausch Health Cos.’ blockbuster drug Xifaxan.

Judge Randolph D. Moss, in an opinion issued Wednesday in the US District Court for the District of Columbia, rejected the Alvogen Group Inc. unit’s bid to require the US Food and Drug Administration to grant final approval of Norwich’s application that includes treating only irritable bowel syndrome with diarrhea—and which carves out the drug’s use for reducing the risk of liver disease complications known as hepatic encephalopathy.

The US Food and Drug Administration ...