Regulatory briefs on vortioxetine, canagliflozin/metformin combo and Rescula

13 December 2012

Takeda Global Research & Development Center, a unit of Japanese drug giant Takeda Pharma’s (TYO: 4502), and Denmark’s Lundbeck (LUND: DC) jointly announced that the US Food and Drug Administration has accepted for filing their submission of a New Drug Application for vortioxetine for the treatment of major depressive disorder (MDD) in adult patients.

According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is targeted for completion by October 2, 2013. Additionally, Takeda and Lundbeck announced Brintellix as the proposed global trade name for vortioxetine, pending final acceptance by the FDA and other regulatory agencies.

Janssen submits NDA for canagliflozin/metformin combo type 2 diabetes

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