Labopharm Inc. (DDSS,DDS.TO) said Tuesday that it has submitted its response to the U.S. Food and Drug Administration's complete response letter regarding the company's novel formulation of the antidepressant trazodone.
Labopharm previously received a complete response letter from the FDA on July 17, indicating the company's new drug application for its novel trazodone formulation could not be approved in its present form due to deficiencies following the FDA's inspection of the active pharmaceutical ingredient manufacturing facility. The letter did not raise any efficacy or safety issues.
The FDA is expected to notify Labopharm within 14 days as to whether or not the company's response has been accepted for review. Once accepted and in accordance with the Prescription Drug User Fee Act, the FDA will assign Labopharm a new action date.
For comments and feedback contact: editorial@rttnews.com
June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.