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Data updated: Mar 10, 2026

VENLAFAXINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE
Neurology Approved 2006-08-03
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
39
Indications
--
Phase 3 Trials
19
Years on Market

Details

Status
Prescription
First Approved
2006-08-03
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE, TABLET, EXTENDED RELEASE, TABLET

Companies

MEDICAP LABS ANNORA PHARMA ASCENT PHARMS INC ALEMBIC Teva PHARMOBEDIENT ALEMBIC PHARMS LTD PRINSTON INC ORBION PHARMS MACLEODS PHARMS LTD AJANTA PHARMA LTD ZYDUS PHARMS VALEANT PHARMS NORTH ZYDUS PHARMS USA INC Aurobindo Pharma NOSTRUM PHARMS LLC CADILA PHARMS LTD SWISS PHARM UNIQUE PLIVA HRVATSKA DOO AMNEAL PHARMS DEXCEL GRANULES Dr. Reddy's YAOPHARMA CO LTD YICHANG HUMANWELL ANCHEN PHARMS HERITAGE ADAPTIS Sun Pharma MPP PHARMA ALKEM LABS LTD ZYDUS PHARMS USA ABON PHARMS LLC TORRENT SCIEGEN PHARMS INVENTIA HLTHCARE SOMERSET THERAPS LLC OSMOTICA PHARM US CHARTWELL RX IMPAX LABS
Active Ingredient: VENLAFAXINE HYDROCHLORIDE

VENLAFAXINE HYDROCHLORIDE Approval History

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What VENLAFAXINE HYDROCHLORIDE Treats

4 indications

VENLAFAXINE 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
Source: FDA Label

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 ...

Drugs Similar to VENLAFAXINE HYDROCHLORIDE

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EFFEXOR XR
VENLAFAXINE HYDROCHLORIDE
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UPJOHN
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CAPLYTA
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CLONAZEPAM
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EMSAM
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FABRE KRAMER
Shared indications:
Major Depressive Disorder
FETZIMA
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AbbVie
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FORFIVO XL
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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

VENLAFAXINE HYDROCHLORIDE FDA Label Details

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Indications & Usage

FDA Label (PDF)

Venlafaxine hydrochloride extended-release capsules are 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 ] Venlafaxine hydrochloride extended-release capsules are 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: ANDA201272 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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