NaF Documentation Page

Fluorine-18 Sodium Fluoride ([18F] NaF)

New Drug Application (NDA) Approved for Fluorine-18 Sodium Fluoride

The NCI announced on February 1, 2011 that the FDA has approved a NDA from the National Cancer Institute (NCI), part of the National Institutes of Health, for a new strength of a previously discontinued drug, [18F] NaF, for use in bone scans. Unlike the Technetium-99m (Tc-99m) based Tc99m MDP, which was previously the only approved radioactive tracer for bone scans, [18F] NaF is easier to produce and is not subject to the recent nationwide risk of Tc99m shortages. Information related to the [18F] NaF NDA include:

• See a history and rationale behind NCI's filing an NDA for [18F] NaF
• Questions/Answers Regarding the NDA Filing for [18F] NaF
• Prescribing Information for [18F] NaF

Component documents for an IND for [18F] NaF

This posting includes an Investigator Drug Brochure, which has been accepted by the FDA as part of the NCI IND. The sodium fluoride can be prepared on-site or purchased from any vendor which has filed a Drug Master File (DMF) for it. There is a USP monograph for [18F] NaF Injection which establishes appropriate quality standards. Investigators then write and file their own IND with the FDA by supplying the CMC section if locally prepared and adding the Investigator's proposed Clinical protocol. NCI will provide a letter to cross-reference the NCI IND file at FDA for pharmacology, toxicology, dosimetry, previous human experience and reference to commercial drug master files. You may wish to consult these [18F] NaF Frequently Asked Questions before going forward. Documents in this section include:

• The [18F] NaF Frequently Asked Questions
• The Investigator's Drug Brochure Template in Microsoft Word Format or Adobe PDF format
• Comprehensive Adverse Events and Potential Risks List (CAEPR) for [18F] NaF

For additional information, contact:

Ismahan Ugas, B.A.
Email: ugasi@mail.nih.gov
Phone: 240-276-6020