Fluoride ion F-18

Overview

Sodium Fluoride F 18 Injection is a positron emitting radiopharmaceutical, no-carrier added. It contains radioactive fluoride F 18 that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging and is administered by intravenous injection. Its primary indication is for bone imaging. Increased deposition around joints can occur in arthritis and following trauma and increased deposition in bone has been noted around fracture sites, in osteomyelitis, fibrous dysplasia, spondylitis tuberculosa, and Paget's disease. No adverse reactions have been reported.

Indication

18F is used as a bone imaging agent to define areas of altered osteogenic activity. It has been indicated for back pain and otherwise unexplained bone pain, child abuse, abnormal radiographic or laboratory findings, osteomyelitis, trauma, inflammatory and degenerative arthritis, avascular necrosis. Osteonecrosis of the mandible, condylar hyperplasia, and metabolic bone disease are also among the indications for fluoride imaging.

Associated Conditions

Altered osteogenesis
Altered osteogenic activity

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparing an Investigational Scan (F-18 NaF PET/CT) to Standard of Care Imaging (F-18 FDG PET/CT) for Evaluating Vascular Complications in Patients Receiving Radiation Therapy for Head and Neck Cancer	2025/04/07	NCT06914999	Early Phase 1	Recruiting	Emory University
Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer	2021/07/29	NCT04981509	Phase 2	Recruiting	National Cancer Institute (NCI)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Sodium Fluoride F 18	The University of Utah DBA Cyclotron Radiochemistry Lab Huntsman Cancer Institute	67939-020	INTRAVENOUS	200 mCi in 1 mL	3/3/2022
Sodium FluorideF 18 F 18	Children's Hospital of Michigan	76167-002	INTRAVENOUS	200 mg in 1 mL	10/24/2011
Sodium Fluoride F18	Cardinal Health 414, LLC	65857-300	INTRAVENOUS	200 mCi in 1 mL	10/3/2016
Sodium Fluoride F 18	Biomedical Research Foundation of Northwest Louisiana	24562-002	INTRAVENOUS	200 mCi in 1 mL	1/14/2015
Sodium Fluoride F 18	SOFIE Co. dba SOFIE	49609-002	INTRAVENOUS	200 mCi in 1 mL	5/7/2020
Sodium Fluoride F 18	PETNET Solutions, Inc.	40028-512	INTRAVENOUS	200 mCi in 1 mL	3/9/2023
Sodium Fluoride F 18	BAMF Health Inc.	81759-002	INTRAVENOUS	200 mCi in 1 mL	12/29/2023
Sodium Fluoride F 18	SOFIE Co.	49609-102	INTRAVENOUS	200 mCi in 1 mL	5/8/2018
Sodium Fluoride F 18	Precision Nuclear LLC	52768-125	INTRAVENOUS	200 mCi in 1 mL	12/23/2022
Sodium Fluoride F 18	Kreitchman PET Center	62072-500	INTRAVENOUS	200 mCi in 1 mL	5/24/2016

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
SODIUM FLUORIDE F18 INJECTION 10-200 mCi/ml	SINGAPORE RADIOPHARMACEUTICALS PTE. LTD.	SIN14436P	INJECTION, SOLUTION (RADIOPHARMACEUTICAL)	10-200mCi/ML	11/11/2013

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
No Health Canada approvals found for this drug.

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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