AN-SULFUR COLLOID (technetium tc-99m sulfur colloid kit)
Technetium Tc 99m Sulfur Colloid is a radioactive diagnostic agent used for various imaging and localization procedures in adults and pediatric patients. In adults, it is specifically indicated to assist in localizing lymph nodes draining primary tumors in breast cancer or malignant melanoma and to evaluate the patency of peritoneo-venous (LeVeen) shunts. In both adults and children, it is used to image functioning reticuloendothelial cells in the liver, spleen, and bone marrow. Additionally, it is used to study esophageal transit, evaluate gastroesophageal reflux, and detect the pulmonary aspiration of gastric contents.
How AN-SULFUR COLLOID Works
Technetium Tc 99m is a radionuclide that decays by isomeric transition, emitting a photon (gamma radiation) that is detected by imaging equipment. The diagnostic utility of the sulfur colloid depends on its route of administration: * **Intravenous:** The colloid particles are taken up by the reticuloendothelial system (RES), allowing for visualization of the liver, spleen, and bone marrow. * **Subcutaneous:** The agent enters lymphatic capillaries and is transported to regional lymph nodes. * **Intraperitoneal:** The agent mixes with peritoneal fluid; the rate at which it clears into systemic circulation is used to assess the patency of peritoneo-venous shunts. * **Oral:** The agent is not absorbed by the gastrointestinal tract, which allows for the scintigraphic evaluation of esophageal transit, gastroesophageal reflux, and pulmonary aspiration.
Details
- Status
- Prescription
- First Approved
- 1978-04-17
- Routes
- INJECTION, ORAL
- Dosage Forms
- SOLUTION
AN-SULFUR COLLOID Approval History
What AN-SULFUR COLLOID Treats
4 indicationsAN-SULFUR COLLOID is approved for 4 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Melanoma
- Gastroesophageal Reflux
- Pulmonary Aspiration
AN-SULFUR COLLOID Competitive Set
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Indication competitors
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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 AN-SULFUR COLLOID's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AN-SULFUR COLLOID treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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Key Completed Trials
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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.
AN-SULFUR COLLOID FDA Label Details
Indications & Usage
FDA Label (PDF)AN-SULFUR COLLOID is indicated for the treatment of Breast Cancer; Melanoma; Gastroesophageal Reflux; Pulmonary Aspiration.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.