THALLOUS CHLORIDE TL 201 (thallous chloride tl-201) · GE HEALTHCARE
Thallous Chloride Tl 201 is a radioactive diagnostic agent used with planar scintigraphy or single-photon emission computed tomography (SPECT) for myocardial perfusion imaging and parathyroid localization in adults. It is indicated for the diagnosis of coronary artery disease by identifying non-reversible defects (myocardial infarction) and reversible defects (ischemia) when used in conjunction with exercise or pharmacologic stress. It is also used to localize sites of parathyroid hyperactivity, both pre- and post-operatively, in patients with elevated serum calcium and parathyroid hormone levels.
How THALLOUS CHLORIDE TL 201 Works
Thallous chloride Tl 201 accumulates in viable myocardium in a manner analogous to potassium, with its distribution correlating directly with regional myocardial perfusion. In clinical imaging, areas of infarction or restricted blood flow appear as "cold" spots (nonlabeled regions). This allows for the identification of permanent tissue damage or transient ischemia when administered during exercise or pharmacologic stress testing.
Details
- Status
- Discontinued
- First Approved
- 1977-12-16
- Routes
- INJECTION, INTRAVENOUS
- Dosage Forms
- INJECTABLE
THALLOUS CHLORIDE TL 201 Approval History
What THALLOUS CHLORIDE TL 201 Treats
4 indicationsTHALLOUS CHLORIDE TL 201 is approved for 4 conditions since its original approval in 1977. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary artery disease
- Myocardial infarction
- Myocardial ischemia
- Parathyroid hyperactivity
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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.
THALLOUS CHLORIDE TL 201 FDA Label Details
Indications & Usage
FDA Label (PDF)Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels Thallous Chloride Tl 201 Injecti...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.