TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

CERETEC

TECHNETIUM TC-99M EXAMETAZIME KIT Radiopharmaceutical Activity
Immunology Approved 1988-12-30
2
Indications
--
Phase 3 Trials
1
Priority Reviews
37
Years on Market

Details

Status
Prescription
First Approved
1988-12-30
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

CERETEC Approval History

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What CERETEC Treats

3 indications

CERETEC is approved for 3 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Stroke
  • Intra-Abdominal Infection
  • Inflammatory Bowel Disease
Source: FDA Label

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Key Completed Trials

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Completed studies with published results, ranked by significance

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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.

CERETEC FDA Label Details

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Indications & Usage

FDA Label (PDF)

Technetium Tc99m exametazime scintigraphy may be useful as an adjunct in the detection of altered regional cerebral perfusion in stroke. Tc99m exametazime is indicated for leukocyte labeled scintigraphy as an adjunct in the localization of intra-abdominal infection and inflammatory bowel disease.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.