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Data updated: Jun 28, 2026

DESVENLAFAXINE (desvenlafaxine fumarate) · Sun Pharma

CNS Approved 2013-03-04
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
13
Years on Market

Details

Status
Discontinued
First Approved
2013-03-04
Routes
ORAL
Dosage Forms
TABLET, EXTENDED RELEASE

Companies

Sun Pharma Teva ALEMBIC PHARMS LTD ANCHEN PHARMS
Active Ingredient: DESVENLAFAXINE FUMARATE

DESVENLAFAXINE Approval History

2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
40 FDA actions from 2013 to 2023
Aug 2023 SUPPL
Label · Labeling
FDA Letter Label
Sep 2021 SUPPL
Label · Labeling
FDA Letter Label
Dec 2019 SUPPL
Label · Labeling
FDA Letter Label

What DESVENLAFAXINE Treats

3 FDA approvals

Originally approved for its first indication in 2013 . Covers 3 distinct patient populations.

  • Other (3)

Sun Pharma's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

LEQSELVI
2024
DEURUXOLITINIB PHOSPHATE
1 designation
WINLEVI
2020
CLASCOTERONE
1 designation
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Clinical Trial Registry

9 trials
Trial Sponsor ID Phase Status Title
NCT04476030 results posted 217-MDD-305 Ph 3 completed A Comparative Study of Sage-217 Plus an Antidepressant (ADT) Versus Placebo Plus an ADT in Adults With Major Depressive Disorder
NCT04448431 VIVRE 18498A Ph 4 completed Comparison of Vortioxetine and Desvenlafaxine in Adult Patients Suffering From Depression
NCT02859103 DVS-01 Ph 4 completed Dimensional Approach to Evaluate Reward Processing in Major Depressive Disorder Pre- and Post-Desvenlafaxine Treatment
NCT01975480 WS2382578 Ph 4 completed Efficacy of SNRI Treatment on Prefrontality in Patients With GAD and Other Comorbities
NCT02200406 WI187002 Pfizer Reference Award Number Ph 4 completed Desvenlafaxine in Opioid-Dependent Patients
NCT01803711 results posted OmegaDVS Ph 2, Ph 3 terminated Omega 3 FA Supplements as Augmentation in the Treatment of Depression
NCT01537068 results posted #6457 Pfizer-WS1895577 Ph 4 completed Desvenlafaxine vs. Placebo Treatment of Chronic Depression
NCT01527786 PRISTIQ IOP # 3151A1-44 Ph 3 completed Functional Outcome in Postpartum Depression in Women Treated With Desvenlafaxine
NCT01443208 B2061137 Ph 1 completed Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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.

DESVENLAFAXINE FDA Label Details

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Data Sources

FDA Approval: NDA205583 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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