Data updated: May 26, 2026
LUVOX CR (fluvoxamine maleate)
CNS
Approved 2008-02-28
1
Indication
--
Phase 3 Trials
18
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-02-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE
LUVOX CR Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
16 FDA actions from 2008 to 2017
What LUVOX CR Treats
1 FDA approvalsOriginally approved for its first indication in 2008 .
- Other (1)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01933919 results posted | M13-970 | Ph 3 | completed | A Phase 3 Study of Fluvoxamine (SME3110) in Pediatric/Adolescent Patients With Obsessive Compulsive Disorder |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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.
LUVOX CR FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.