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H Lundbeck A/S and Takeda Pharmaceutical Co Ltd's Filing for Review of Brintellix (Vortioxetine) Accepted by FDA

Wednesday, 12 Dec 2012 02:00pm EST 

H Lundbeck A/S (Lundbeck) announced that the United States (US) Food and Drug Administration (FDA) has accepted the submission of a New Drug Application (NDA) made by Lundbeck and Takeda Pharmaceutical Co Ltd (Takeda) for Brintellix (vortioxetine) for the treatment of major depressive disorder (MDD) in adult patients. Brintellix is the proposed global trade name for vortioxetine. 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. The NDA includes positive data from six short-term studies and one long-term maintenance study. The vortioxetine global clinical development program included more than 7,500 individuals aged 18 to 88 years old exposed to the drug. Major depression, often referred to as depression, is a common, debilitating illness affecting around 15 million Americans and 121 million people worldwide. Depression was the third main contributor to the global burden of disease in 2004 and is projected to be the main contributor to the worldwide burden of disease by 2030. 

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