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Data updated: Jun 28, 2026

FLUORINE F-18 (sodium fluoride f-18) · GE HEALTHCARE

Other Approved 1972-02-24

FLUORINE F-18 is FDA-approved to treat 1 condition (same as SODIUM FLUORIDE F-18).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
1
Priority Reviews
54
Years on Market

Details

Status
Discontinued
First Approved
1972-02-24
Routes
INTRAVENOUS
Dosage Forms
INJECTABLE

Companies

GE HEALTHCARE
Active Ingredient: SODIUM FLUORIDE F-18

FLUORINE F-18 Approval History

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Original
New Indication
New Form
Label Update
1 FDA actions from 1972 to 1972
Feb 1972 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity

What FLUORINE F-18 Treats

1 indications

FLUORINE F-18 is approved for 1 conditions since its original approval in 1972. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Altered Osteogenic Activity

Same approved indications as SODIUM FLUORIDE F-18 (same active ingredient).

Source: FDA Label

GE HEALTHCARE's other novel FDA approvals

Other CDER-designated drugs from the same sponsor (2016–2025).

CERIANNA
2020
FLUOROESTRADIOL F-18
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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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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

FLUORINE F-18 FDA Label Details

Indications & Usage

FLUORINE F-18 is FDA-approved to treat 1 condition — same approved indications as SODIUM FLUORIDE F-18.

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Data Sources

FDA Approval: NDA017042 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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