Labopharm Inc. (DDSS,DDS.TO) said that the FDA has accepted its response regarding its novel formulation of the antidepressant trazodone as complete and designated it as a Class 2 resubmission.
The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010.
Labopharm 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 manufacturing facility of the active pharmaceutical ingredient (API) supplier, Angelini.
The letter did not raise any efficacy or safety issues. Angelini submitted an action plan addressing the deficiencies to the FDA on July 24.
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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.