Medmonitor

An up-to-date timeline of U.S. Food and Drug Administration (FDA) approvals that could potentially impact workers' compensation. These include new drug and indication approvals, new dosages or formulations of existing products, and generics introduced to the market. Click through the interactive timeline below, or select the comprehensive list view.
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Medication Type: Mental Health

Exxua (gepirone) extended-release tablets

Approval Date: Sep 2023

Note: New Product

Indicated for the treatment of major depressive disorder (MDD), a first-in-class drug that selectively targets the serotonin 1A receptor

Abilify Asimtufii® (aripiprazole)

Approval Date: Apr 2023

Note: New Formulation

Indicated for the treatment of schizophrenia or as maintenance monotherapy treatment of bipolar I disorder

Uzedy (risperidone) extended-release injectable suspension

Approval Date: Apr 2023

Note: New Formulation

Indicated for the treatment of schizophrenia in adults

Rexulti® (brexpiprazole) tablets

Approval Date: Aug 2022

Note: First-Time Generic

Indicated for the adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD)

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets

Approval Date: Aug 2022

Note: New Product

For the treatment of major depressive disorder, this antidepressant is notable for producing antidepressant results within one week

Igalmi (dexmedetomidine) sublingual film

Approval Date: Apr 2022

Note: New Product

Indicated for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

Paxil (paroxetine) oral suspension

Approval Date: Sep 2021

Note: First-Time Generic

Indicated for the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and PTSD

Trintellix® (vortioxetine) tablets

Approval Date: Sep 2021

Note: First-Time Generic

Indicated for the treatment of major depressive disorder (MDD)

Loreev XR (lorazepam) extended release capsules

Approval Date: Sep 2021

Note: New Product

For the treatment of anxiety disorders in adults receiving stable, evenly divided, three times daily dosing with lorazepam tablets

LYBALVI (OLANZAPINE AND SAMIDORPHAN) TABLETS FOR ORAL USE

Approval Date: May 2021

Note: New Product

A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder

Medication Name

Approval Date

Category

Description

Exxua (gepirone) extended-release tablets

Sep 2023

Indicated for the treatment of major depressive disorder (MDD), a first-in-class drug that selectively targets the serotonin 1A receptor

Note: New Product

Abilify Asimtufii® (aripiprazole)

Apr 2023

Indicated for the treatment of schizophrenia or as maintenance monotherapy treatment of bipolar I disorder

Note: New Formulation

Uzedy (risperidone) extended-release injectable suspension

Apr 2023

Indicated for the treatment of schizophrenia in adults

Note: New Formulation

Rexulti® (brexpiprazole) tablets

Aug 2022

Indicated for the adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD)

Note: First-Time Generic

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets

Aug 2022

For the treatment of major depressive disorder, this antidepressant is notable for producing antidepressant results within one week

Note: New Product

Igalmi (dexmedetomidine) sublingual film

Apr 2022

Indicated for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder

Note: New Product

Paxil (paroxetine) oral suspension

Sep 2021

Indicated for the treatment of major depressive disorder, obsessive compulsive disorder, panic disorder, social anxiety disorder, generalized anxiety disorder, and PTSD

Note: First-Time Generic

Trintellix® (vortioxetine) tablets

Sep 2021

Indicated for the treatment of major depressive disorder (MDD)

Note: First-Time Generic

Loreev XR (lorazepam) extended release capsules

Sep 2021

For the treatment of anxiety disorders in adults receiving stable, evenly divided, three times daily dosing with lorazepam tablets

Note: New Product

LYBALVI (OLANZAPINE AND SAMIDORPHAN) TABLETS FOR ORAL USE

May 2021

A combination antipsychotic and opioid antagonist for the treatment of schizophrenia, bipolar I disorder

Note: New Product
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