ETODOLAC
ETODOLAC is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Acute Pain.
Details
- Status
- Discontinued
- First Approved
- 1997-02-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET, TABLET, EXTENDED RELEASE
Companies
ETODOLAC Approval History
What ETODOLAC Treats
3 indicationsETODOLAC is approved for 3 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Osteoarthritis
- Rheumatoid Arthritis
- Acute Pain
ETODOLAC Boxed Warning
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). Etodolac tablets, 400 mg and 500 mg are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). Gastrointestinal Risk...
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS ). Etodolac tablets, 400 mg and 500 mg are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal (GI) events (see WARNINGS ).
ETODOLAC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ETODOLAC's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ETODOLAC treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to ETODOLAC
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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.
ETODOLAC FDA Label Details
Indications & Usage
FDA Label (PDF)ETODOLAC is indicated for the treatment of Osteoarthritis; Rheumatoid Arthritis; Acute Pain.
Cardiovascular Thrombotic Events Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNIN...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.