LODINE XL (etodolac) · Pfizer
LODINE XL is FDA-approved to treat 3 conditions (same as ETODOLAC).
Development Insights
Details
- Status
- Discontinued
- First Approved
- 1996-10-25
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
LODINE XL Approval History
What LODINE XL Treats
3 indicationsLODINE XL is approved for 3 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Acute Pain
Same approved indications as ETODOLAC (same active ingredient).
Pfizer's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03127592 FDCETCB-III | ETCAPS0317OR-III | Ph 3 | terminated | Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction |
| NCT01198834 | MRX-7EAT-1005 | Ph 3 | completed | MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains |
| NCT02881619 | UFS | Ph 4 | completed | Etodolac and Post-bleaching Sensitivity |
| NCT01118572 | 177-CL-102 | Ph 3 | completed | A Study to Verify the Efficacy of YM177 (Celecoxib) in Postoperative Pain Patients |
| NCT01749228 | Ipca/VIN-11/416 | Ph 1 | completed | Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fed Condition |
| NCT01746719 | Ipca/VIN-11/415 | Ph 1 | completed | Bioequivalence Study of Etodolac Capsules USP 300 mg Under Fasting Condition |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
LODINE XL FDA Label Details
Indications & Usage
FDA Label (PDF)LODINE XL is FDA-approved to treat 3 conditions — same approved indications as ETODOLAC.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment