Alvogen Sues FDA to Force Final Approval of Its Xifaxan Copy

Alvogen Group Inc.’s Norwich Pharmaceuticals Inc. alleges in a new lawsuit that the US Food and Drug Administration’s refusal to grant final approval of its proposed generic version of Bausch Health Cos.’ blockbuster Xifaxan “subverts its own regulations and directly contradicts” federal law.

The FDA on June 2 only tentatively approved a version of Norwich’s application that carves out the drug’s use for reducing the risk of liver disease complications known as hepatic encephalopathy, or HE, according to a complaint filed Monday in the US District Court for the District of Columbia.

Final approval is required before a company ...