Sodium fluoride
As of the edition of 20 October 2026, Sodium fluoride is a small molecule: marketed, first approved in 1982 (US); no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1994
- Kind
- Small molecule
- Brand name
- Fluorine F-18
- First approved
- 1 January 1982 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- National Institutes Health National Cancer; 6 holders in all
- Registered trials
- 47, 1 stopped early
- Disease areas
- Mouth and teeth; Cancer; Urinary and reproductive; Infections; Lungs and airways; Ear, nose and throat
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 8 | 1 | 0 |
| Phase 1 | 10 | 8 | 1 | 1 |
| Phase 2 | 13 | 10 | 3 | 0 |
| Phase 3 | 10 | 7 | 0 | 0 |
| Phase 4 | 5 | 3 | 1 | 0 |
| All trials | 47 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| National Institutes Health National Cancer | Later holder | 2011 to now |
| GE Healthcare | Applicant |