Metrochem Vortioxetine Hydrobromide Metrochem Vortioxetine Hydrobromide

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  • TABLET;ORAL - EQ 10MG BASE
  • TABLET;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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Details:

Vortioxetine is a novel antidepressant with multimodal activity, which is approved to treat Major Depressive Disorder (MDD) in adults. The product is approved in over 80 countries1 , including the US, EU, Canada and Australia.


Lead Product(s): Vortioxetine Hydrobromide

Therapeutic Area: Psychiatry/Psychology Product Name: Vortidif

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: H. Lundbeck AS

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement March 30, 2022

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Details:

USFDA has given tentatively approved ANDA, a therapeutically equivalent reference listed drug product for Vortioxetine-Generic (Vortioxetine), indicated for the treatment of major depressive disorder.


Lead Product(s): Vortioxetine Hydrobromide

Therapeutic Area: Psychiatry/Psychology Product Name: Vortioxetine-Generic

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 07, 2022

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A new study shows that people living with Major Depressive Disorder (MDD) and comorbid Generalized Anxiety Disorder (GAD) benefit from treatment with vortioxetine as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).


Lead Product(s): Vortioxetine Hydrobromide

Therapeutic Area: Psychiatry/Psychology Product Name: Trintellix

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 03, 2021

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Details:

In a new real-world study, the ability of Trintellix/Brintellix® (vortioxetine) to improve functioning in family, social, and work life for people living with Major Depressive Disorder was assessed.


Lead Product(s): Vortioxetine Hydrobromide

Therapeutic Area: Psychiatry/Psychology Product Name: Trintellix

Highest Development Status: ApprovedProduct Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 22, 2021

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