DRAX EXAMETAZIME (technetium tc-99m exametazime kit)
Drax Exametazime is a radioactive diagnostic tool used to help locate areas of infection or inflammation within the abdomen. It works by labeling a patient's white blood cells, allowing healthcare providers to visualize specific sites of concern, such as intra-abdominal infections or inflammatory bowel disease. This agent is typically used alongside other diagnostic methods to pinpoint the exact location of these conditions.
How DRAX EXAMETAZIME Works
This agent works by forming a fat-soluble complex that is easily absorbed and held within the patient's white blood cells. Once these labeled cells are reintroduced into the body, they naturally migrate to sites of infection or inflammation, where the radioactive component allows for clear imaging.
Details
- Status
- Prescription
- First Approved
- 2017-08-17
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
DRAX EXAMETAZIME Approval History
What DRAX EXAMETAZIME Treats
2 indicationsDRAX EXAMETAZIME is approved for 2 conditions since its original approval in 2017. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Intra-Abdominal Infection
- Inflammatory Bowel Disease
DRAX EXAMETAZIME 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 DRAX EXAMETAZIME's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications DRAX EXAMETAZIME treats. First-in-class if their pivotal trials read out positive.
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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.
DRAX EXAMETAZIME FDA Label Details
Indications & Usage
FDA Label (PDF)DRAX EXAMETAZIME is indicated for the treatment of Intra-Abdominal Infection; Inflammatory Bowel Disease.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.