DURACLON
Details
- Status
- Prescription
- First Approved
- 1996-10-02
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DURACLON Approval History
What DURACLON Treats
4 indicationsDURACLON is approved for 4 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cancer
- Neuropathic Pain
- Somatic Pain
- Visceral Pain
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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.
DURACLON FDA Label Details
ProIndications & Usage
FDA Label (PDF)Duraclon is indicated in combination with opiates for the treatment of severe pain in cancer patients that is not adequately relieved by opioid analgesics alone. Epidural clonidine is more likely to be effective in patients with neuropathic pain than somatic or visceral pain (see Clinical Trials ). The safety of this drug product has only been established in a highly selected group of cancer patients, and only after an adequate trial of opioid analgesia. Other use is of unproven safety and is not recommended. In a rare patient, the potential benefits may outweigh the known risks (see WARNINGS ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.