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Trintellix FDA Approval History

FDA Approved: Yes (First approved September 30, 2013)
Brand name: Trintellix
Generic name: vortioxetine
Dosage form: Tablets
Previous Name: Brintellix
Company: Takeda Pharmaceutical Company Limited
Treatment for: Depression

Trintellix (vortioxetine) is a multimodal antidepressant for the treatment of major depressive disorder (MDD).

Trintellix was first approved as Brintellix (vortioxetine) on September 30, 2013.

On May 2, 2016, Takeda Pharmaceuticals U.S.A., Inc. announced that Brintellix (vortioxetine) would be marketed under the new name Trintellix (vortioxetine) effective June 2016. The name change came after reports of name confusion in the marketplace between Brintellix and the anti-blood clotting therapy Brilinta (ticagrelor).

Development timeline for Trintellix

May  2, 2016Approval Brintellix (vortioxetine) Renamed Trintellix (vortioxetine) in U.S. to Avoid Name Confusion
Sep 30, 2013Approval FDA Approves Brintellix to Treat Major Depressive Disorder
Dec 12, 2012FDA Accepts Takeda and Lundbeck's Submission of the New Drug Application for Vortioxetine for the Treatment of Major Depressive Disorder
Oct  1, 2012Takeda and Lundbeck Announce the U.S. Submission of a New Drug Application for Vortioxetine, an Investigational Drug for the Treatment of Major Depressive Disorder

Further information

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