FDA — authorised 25 February 2011
- Application: ANDA079086
- Marketing authorisation holder: PETNET
- Status: supplemented
🇺🇸 FLUDEOXYGLUCOSE F 18 in United States
FDA authorised FLUDEOXYGLUCOSE F 18 on 25 February 2011 · 107 US adverse-event reports
Marketing authorisations
FDA — authorised 29 October 2014
- Application: ANDA203801
- Marketing authorisation holder: TRUSTEES UNIV PA
- Status: approved
FDA — authorised 30 October 2014
- Application: ANDA203816
- Marketing authorisation holder: BRIGHAM WOMENS
- Status: supplemented
FDA — authorised 18 December 2014
- Application: ANDA204264
- Marketing authorisation holder: PHARMALOGIC
- Status: supplemented
FDA — authorised 7 April 2015
- Application: ANDA204546
- Marketing authorisation holder: PRECISION NUCLEAR
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 107
Most-reported reactions
- Cytokine Release Syndrome — 20 reports (18.69%)
- Drug Ineffective — 16 reports (14.95%)
- Off Label Use — 13 reports (12.15%)
- Neutropenia — 10 reports (9.35%)
- Wrong Product Administered — 10 reports (9.35%)
- Nausea — 9 reports (8.41%)
- Product Label On Wrong Product — 8 reports (7.48%)
- Death — 7 reports (6.54%)
- Hypotension — 7 reports (6.54%)
- Rash Maculo-Papular — 7 reports (6.54%)
FLUDEOXYGLUCOSE F 18 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is FLUDEOXYGLUCOSE F 18 approved in United States?
Yes. FDA authorised it on 25 February 2011; FDA authorised it on 29 October 2014; FDA authorised it on 30 October 2014.
Who is the marketing authorisation holder for FLUDEOXYGLUCOSE F 18 in United States?
PETNET holds the US marketing authorisation.