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RSS FeedsLundbeck and Takeda receive Complete Response Letter from the FDA for Trintellix
(WorldNews Denmark)

 
 

23 june 2017 03:56:58

 
Lundbeck and Takeda receive Complete Response Letter from the FDA for Trintellix
(WorldNews Denmark)
 


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 w ......


 
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