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Data updated: Mar 10, 2026

TECHNETIUM TC 99M SESTAMIBI

TECHNETIUM TC-99M SESTAMIBI KIT Radiopharmaceutical Activity
Oncology Approved 2008-09-22
4
Indications
--
Phase 3 Trials
17
Years on Market

Details

Status
Prescription
First Approved
2008-09-22
Routes
INJECTION
Dosage Forms
INJECTABLE

TECHNETIUM TC 99M SESTAMIBI Approval History

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What TECHNETIUM TC 99M SESTAMIBI Treats

4 indications

TECHNETIUM 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
Source: FDA Label

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Trial Timeline

Full development history with FDA approval milestones

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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.

TECHNETIUM TC 99M SESTAMIBI FDA Label Details

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Indications & 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.