VENLAFAXINE HYDROCHLORIDE
Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for use in adult patients. The medication is approved for the treatment of major depressive disorder and generalized anxiety disorder. Additionally, it is utilized in the management of social anxiety disorder and panic disorder in the adult population.
How VENLAFAXINE HYDROCHLORIDE Works
While the exact mechanism of action is unclear, venlafaxine is thought to work by inhibiting the reuptake of serotonin and norepinephrine in the central nervous system. By blocking the reabsorption of these neurotransmitters, the drug potentiates their activity. This increase in serotonin and norepinephrine levels is believed to produce the therapeutic effects necessary for treating depression and anxiety disorders.
Details
- Status
- Discontinued
- First Approved
- 2006-08-03
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET, TABLET, EXTENDED RELEASE
Companies
VENLAFAXINE HYDROCHLORIDE Approval History
What VENLAFAXINE HYDROCHLORIDE Treats
4 indicationsVENLAFAXINE HYDROCHLORIDE is approved for 4 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Social Anxiety Disorder
- Panic Disorder
VENLAFAXINE HYDROCHLORIDE Boxed Warning
SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1 )] . Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients [see Use in Specific Populations (8.4) ] . WARNING: SUICIDAL THOUGHTS AND ...
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.1 )] . Venlafaxine hydrochloride extended-release capsules 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 risk of suicidal thoughts and behavior in pediatric patients and young adults taking antidepressants. Closely monitor all antidepressant-treated patients for clinical worsening and emergence of suicidal thoughts and behaviors (5.1) . • Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients (8.4) .
VENLAFAXINE HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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
Ongoing clinical trials by development phase
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.
VENLAFAXINE HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)VENLAFAXINE HYDROCHLORIDE is indicated for the treatment of Major Depressive Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and emergence of suicidal thoughts and behaviors [see...
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EFFEXOR XR
Full clinical data, patents, trials, and competitive landscape for venlafaxine hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.