TECHNETIUM TC 99M SESTAMIBI
Details
- Status
- Prescription
- First Approved
- 2008-09-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
TECHNETIUM TC 99M SESTAMIBI Approval History
What TECHNETIUM TC 99M SESTAMIBI Treats
4 indicationsTECHNETIUM TC 99M SESTAMIBI is approved for 4 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Coronary Artery Disease
- Myocardial Ischemia
- Myocardial Infarction
- Breast Lesions
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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 SESTAMIBI FDA Label Details
ProIndications & Usage
Myocardial Imaging: Kit for the preparation of Technetium Tc 99m Sestamibi Injection is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Technetium Tc 99m Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agents labeling)...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.