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Data updated: Mar 10, 2026

EFFEXOR XR

VENLAFAXINE HYDROCHLORIDE
Neurology Approved 1997-10-20
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
9
Indications
--
Phase 3 Trials
1
Priority Reviews
28
Years on Market

Details

Status
Prescription
First Approved
1997-10-20
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

UPJOHN
Active Ingredient: VENLAFAXINE HYDROCHLORIDE

EFFEXOR XR Approval History

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What EFFEXOR XR Treats

4 indications

EFFEXOR XR is approved for 4 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Major Depressive Disorder
  • Generalized Anxiety Disorder
  • Social Anxiety Disorder
  • Panic Disorder
Source: FDA Label

EFFEXOR XR 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) ]. Effexor XR is not approved for use in pediatric patients [see Use in Specific Populations (8.4) ]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information f...

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Trial Timeline

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Full development history with FDA approval milestones

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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.

EFFEXOR XR FDA Label Details

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Indications & Usage

FDA Label (PDF)

Effexor XR is indicated in adults for the treatment of: • Major Depressive Disorder (MDD) [see Clinical Studies ] • Generalized Anxiety Disorder (GAD) [see Clinical Studies ] • Social Anxiety Disorder (SAD) [see Clinical Studies ] • Panic Disorder (PD) [see Clinical Studies ] Effexor XR is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: • Major Depressive Disorder (MDD) • Generalized Anxiety Disorder (GAD) • Social Anxiety Disorder (SAD) • Panic Disorder (PD)

⚠️ BOXED WARNING

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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Data Sources

FDA Approval: NDA020699 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.