Bausch Health sheds 13% as Norwich sues for final FDA approval of Xifaxan

• Bausch Health (NYSE:BHC) lost ~13% on Tuesday after the Canadian pharma said that generic drugmaker Norwich Pharma filed a lawsuit against the FDA seeking final approval for its version of the company's bowel disease therapy Xifaxan immediately.
• The litigation filed in the District Court for the District of Columbia comes after a federal court judge in Delaware denied a motion to modify a previous ruling that prevented the FDA from approving Norwich's abbreviated new drug application (ANDA) for Xifaxan until 2029.
• However, Bausch Health (BHC) notes that the FDA has issued tentative approval for Norwich's ANDA early this month, indicating that the agency could not grant final approval until Oct. 2, 2029.
• That has led to the latest lawsuit in which Norwich seeks a court directive requiring the FDA to grant final approval for the ANDA immediately. Bausch Health (BHC) said it intends to intervene in Norwich's lawsuit "and will continue to take all steps to vigorously defend its intellectual property."

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