TheraRadar

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Data updated: Mar 10, 2026

SODIUM FLUORIDE F-18

SODIUM FLUORIDE F-18
Approved 2011-01-26
24
Indications
--
Phase 3 Trials
1
Priority Reviews
15
Years on Market

SODIUM FLUORIDE F-18 Approval History

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What SODIUM FLUORIDE F-18 Treats

1 indications

SODIUM FLUORIDE F-18 is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Altered Osteogenic Activity
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.

SODIUM FLUORIDE F-18 FDA Label Details

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Indications & Usage

Sodium Fluoride F 18 Injection, USP is indicated for diagnostic positron emission tomography (PET) imaging of bone to define areas of altered osteogenic activity. Sodium Fluoride F 18 Injection, USP is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity .

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Data Sources

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