NEW YORK (AP) — Canadian drug maker Labopharm Inc. said Tuesday the U.S. FDA has accepted its response regarding the formula of the antidepressant trazodone, and will decide on the drug’s approval by Feb. 11, 2010. Labopharm intends to launch the drug in the U.S. market shortly after receiving FDA approval. The FDA sent a letter to the drugmaker last month saying Labopharm’s initial application was not approved after the agency inspected the manufacturing facility of the active pharmaceutical ingredient supplier, Angelini. The letter did not raise any issues about the drug’s safety or effectiveness. Angelini submitted an action plan addressing the deficiencies to the FDA a week later.
