Data updated: May 26, 2026
RELAFEN (nabumetone)
Immunology
Approved 1991-12-24
1
Indication
--
Phase 3 Trials
34
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1991-12-24
- Routes
- ORAL
- Dosage Forms
- TABLET
RELAFEN Approval History
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
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
34 FDA actions from 1991 to 2006
Oct 2001 SUPPL
Label · Labeling
Jun 2001 SUPPL
Mfg
Aug 1999 SUPPL
Mfg
Feb 1998 SUPPL
Mfg
Jul 1996 SUPPL
Mfg
Jun 1996 SUPPL
Mfg
Jul 1995 SUPPL
Mfg
May 1995 SUPPL
Mfg
Jan 1995 SUPPL
Mfg
Oct 1994 SUPPL
Mfg
Sep 1994 SUPPL
Mfg
Nov 1993 SUPPL
Label
Jan 1993 SUPPL
Mfg
Dec 1991 ORIGINAL
New Drug
What RELAFEN Treats
1 FDA approvalsOriginally approved for its first indication in 1991 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 1991)
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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.
RELAFEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.