FDA approves Oleptro

FDA approved an NDA from Labopharm Inc. (TSX:DDS; NASDAQ:DDSS) for Oleptro trazodone extended-release tablets to treat major depressive disorder (MDD). Oleptro's label includes a black box warning about the risk of suicidality associated with antidepressant drugs. Also as part of the approval, Labopharm plans to conduct a postmarketing pediatric study and provide FDA with data from a long-term maintenance study and an additional in vitro alcohol dissolution study. ...