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# Trintellix Not Withdrawn Due to Safety/Effectiveness: FDA
- URL: https://www.fdaweb.com/trintellix-not-withdrawn-due-to-safety-effectiveness-fda/
- Published: 2017-11-21T12:00:00.000Z
- Updated: 2026-09-14T23:02:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140179

*Federal Register* notice: FDA has determined that Takeda’s Trintellix (vortioxetine hydrobromide) oral tablet, indicated for treating major depressive disorder, was not withdrawn due to safety or effectiveness concerns. The determination was in response to several citizen petition requests and will allow the agency to approve ANDAs referencing the product if all other legal and regulatory requirements are met. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-11-21/pdf/2017-25156.pdf?ref=fdaweb.com).