By Robb M. Stewart

Bausch Health's shares were down sharply Tuesday after a lawsuit was filed against the U.S. Food and Drug Administration in an attempt to overturn its judgement preventing an application for a rival generic irritable bowel syndrome drug from gaining approval before 2029.

In morning trading, the shares were 12% lower at C$9.44 on the Toronto Stock Exchange and down 11% at $7.07 in New York.

Bausch said Norwich Pharmaceuticals has sued the FDA in the District Court for the District of Columbia requesting the court direct the FDA to immediately grant final approval of its abbreviated new drug application.

Bausch said it intends to intervene in Norwich's lawsuit against the FDA and will continue to take all steps to vigorously defend its intellectual property.

In May, a U.S. district court stuck with an earlier judgment that prevented the application for a rival generic version of Bausch's Xifaxan from getting FDA approval until 2029. At the time, the company and its gastroenterology business Salix Pharmaceuticals said that the U.S. District Court of Delaware denied a motion by Norwich to alter the court's final judgment on the matter. The ruling stems from a patent-infringement lawsuit against Norwich brought by Bausch and Salix in 2020.

Bausch on Tuesday said it understands that the FDA this month granted Norwich tentative approval of its abbreviated new drug application but confirmed it can't grant final approval until Oct. 2, 2029.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

June 06, 2023 11:15 ET (15:15 GMT)

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