ROBAXIN (methocarbamol) · ENDO OPERATIONS
The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
Details
- Status
- Discontinued
- First Approved
- 1957-07-16
- Routes
- ORAL, IM-IV
- Dosage Forms
- TABLET, SOLUTION
ROBAXIN Approval History
What ROBAXIN Treats
1 indicationsROBAXIN is approved for 1 conditions since its original approval in 1957. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Musculoskeletal Conditions
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05603832 | 100-CIP02-P | Ph 3 | completed | A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement |
| NCT05388929 | 1913843 | Ph 4 | active not recruiting | Methocarbamol in Ventral and Inguinal HR |
| NCT05076110 results posted | 21-003441 | Ph 4 | completed | Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures |
| NCT02432456 results posted | PRO00024679 | Ph 4 | completed | Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients |
| NCT02831569 results posted | 1387.1 | Ph 3 | completed | Japanese IP-TN Trial |
| NCT02665286 results posted | 2015-5903 | Ph 4 | completed | Orphenadrine and Methocarbamol for LBP |
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.
ROBAXIN FDA Label Details
Indications & Usage
FDA Label (PDF)The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.