Lundbeck and Takeda receive Complete Response Letter from the FDA for Trintellix® (vortioxetine) sNDA
Valby, Denmark and Osaka, Japan, 23 June 2017 - H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) today announced that after providing additional analysis, the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the supplemental new drug application (sNDA) to include new data in the clinical trials section of the U.S. prescribing information of Trintellix (vortioxetine) for treating aspects of cognitive dysfunction in adults with major depressive disorder (MDD). Takeda and Lundbeck are disappointed, but we believe in