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# Complete Response Letter for Brintellix sNDA
- URL: https://www.fdaweb.com/complete-response-letter-for-brintellix-snda/
- Published: 2016-03-29T12:00:00.000Z
- Updated: 2026-09-14T20:51:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135221

> FDA has issued Takeda Pharmaceutical Co. and H. Lundbeck A a complete response letter for a supplemental NDA for Brintellix (vortioxetine) that sought to include new data in the drug’s clinical trials labeling section for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). The agency originally approved Brintellix 9/2013 for treating MDD in adults.  
>  
> The letter comes as a surprise to the companies considering that FDA’s Psychopharmacologic Drugs Advisory Committee last month voted 8 to 2 to recommend approving the sNDA. Before voting, panel members agreed that cognitive dysfunction in MDD is an appropriate drug target ([see earlier story](http://fdaweb.com/login.php?sa=v&aid=D5134629&cate=&stid=%241%24wR%2F.3U5.%247DFfRlWvYSfbZRm7c973H%2F&ref=fdaweb.com)). As a recommended endpoint in such studies, the panel said the Digital Symbol Substitution Test combined with outcomes from secondary endpoints could support a claim for improving cognition.  
>  
> Takeda and Lundbeck say they plan to review the letter’s contents with the agency to determine the appropriate path forward.