TECHNETIUM TC-99M SULFUR COLLOID KIT
Technetium Tc 99m Sulfur Colloid is a radioactive diagnostic agent used for various imaging and functional studies. In adults, it is indicated for the localization of lymph nodes draining primary tumors in patients with breast cancer or malignant melanoma (using a hand-held gamma counter) and for evaluating the patency of peritoneo-venous (LeVeen) shunts. In both adult and pediatric patients, it is indicated for imaging the reticuloendothelial system (liver, spleen, and bone marrow) and for gastrointestinal studies, including esophageal transit, gastroesophageal reflux, and the detection of pulmonary aspiration of gastric contents.
How TECHNETIUM TC-99M SULFUR COLLOID KIT Works
Technetium Tc 99m decays by isomeric transition, emitting a gamma photon that is detectable for diagnostic imaging. The mechanism of action depends on the route of administration: * **Subcutaneous:** The colloid enters lymphatic capillaries and is transported to regional lymph nodes. * **Intraperitoneal:** The agent mixes with peritoneal fluid; its rate of clearance into systemic circulation is used to assess the patency of peritoneo-venous shunts. * **Intravenous:** The particles are phagocytized by the reticuloendothelial system (RES), allowing for the visualization of RES-rich structures such as the liver, spleen, and bone marrow. * **Oral:** The agent is not absorbed by the gastrointestinal tract, allowing for the scintigraphic evaluation of esophageal transit, gastroesophageal reflux, and pulmonary aspiration.
Details
- Status
- Prescription
- First Approved
- 2023-11-09
- Routes
- INJECTION, ORAL
- Dosage Forms
- SOLUTION
TECHNETIUM TC-99M SULFUR COLLOID KIT Approval History
What TECHNETIUM TC-99M SULFUR COLLOID KIT Treats
4 indicationsTECHNETIUM TC-99M SULFUR COLLOID KIT is approved for 4 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
- Melanoma
- Gastroesophageal Reflux
- Pulmonary Aspiration
TECHNETIUM TC-99M SULFUR COLLOID KIT 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 TECHNETIUM TC-99M SULFUR COLLOID KIT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TECHNETIUM TC-99M SULFUR COLLOID KIT 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.
TECHNETIUM TC-99M SULFUR COLLOID KIT FDA Label Details
Indications & Usage
TECHNETIUM TC-99M SULFUR COLLOID KIT is indicated for the treatment of Breast Cancer; Melanoma; Gastroesophageal Reflux; Pulmonary Aspiration.
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AN-SULFUR COLLOID
Full clinical data, patents, trials, and competitive landscape for technetium tc-99m sulfur colloid kit.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.