DESVENLAFAXINE SUCCINATE
DESVENLAFAXINE SUCCINATE is indicated for the treatment of Major Depressive Disorder.
Details
- Status
- Prescription
- First Approved
- 2015-06-29
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
DESVENLAFAXINE SUCCINATE Approval History
What DESVENLAFAXINE SUCCINATE Treats
1 indicationsDESVENLAFAXINE SUCCINATE is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
DESVENLAFAXINE SUCCINATE Boxed Warning
BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS ( 5.1 )]. In patients of all ages who are started on antidepre...
BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [see WARNINGS AND PRECAUTIONS ( 5.1 )]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see WARNINGS AND PRECAUTIONS ( 5.1 )]. Desvenlafaxine extended-release tablets are not approved for use in pediatric patients [see USE IN SPECIFIC POPULATIONS ( 8.4 ) ] . WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Increased the risk of suicidal thoughts and behaviors in children, adolescents and young adults taking antidepressants ( 5.1 ). • Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ). • Desvenlafaxine extended-release tablets are not approved for use in pediatric patients ( 8.4 ).
DESVENLAFAXINE SUCCINATE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DESVENLAFAXINE SUCCINATE FDA Label Details
Indications & Usage
DESVENLAFAXINE SUCCINATE is indicated for the treatment of Major Depressive Disorder.
BOXED WARNING WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use i...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.