TheraRadar
Data updated: May 26, 2026

SODIUM FLUORIDE F-18

Other Approved 2011-01-26

Sodium Fluoride F-18 is a radioactive diagnostic tool used for PET imaging of the skeletal system. It helps healthcare providers identify and define specific areas where bone activity has changed or become irregular. Patients receive this injection to allow for detailed visualization of the bones during diagnostic scans.

Source: FDA Label • NCM USA BRONX LLC

How SODIUM FLUORIDE F-18 Works

This agent works by depositing fluoride F18 ions throughout the skeleton, with higher concentrations typically found in the vertebrae, pelvis, and joints. By accumulating in these areas, the drug allows for the detection of variations in bone formation and activity.

Source: FDA Label
24
Indications
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Phase 3 Trials
1
Priority Reviews
15
Years on Market

SODIUM FLUORIDE F-18 Approval History

2012
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2026
Original
New Indication
New Form
Label Update
26 FDA actions from 2011 to 2022
Dec 2022 ORIGINAL
Update
Jun 2020 SUPPL
Mfg · Manufacturing (CMC)
May 2016 ORIGINAL
Update

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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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT04981509 NCI-2021-07744 NCI-2021-07744, 22-C-0004 Ph 2 recruiting Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer
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Active Pipeline

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Ongoing clinical trials by development phase

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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

Indications & Usage

SODIUM FLUORIDE F-18 is indicated for the treatment of Altered Osteogenic Activity.

Looking for the branded version?

FLUORINE F-18

Full clinical data, patents, trials, and competitive landscape for sodium fluoride f-18.

See FLUORINE F-18

Data Sources

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