Active substance
Gallium ga 68 gozetotide
- US FDA 7
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| GALLIUM GA 68 GOZETOTIDE | 0.5-5mCi/mL | solution · intravenous | UNIV CA LOS ANGELES | Prescription | 1 Dec 2020 |
| GALLIUM GA 68 GOZETOTIDE | 0.5-5mCi/mL | solution · intravenous | UNIV OF CA SAN FRAN | Prescription | 1 Dec 2020 |
| ILLUCCIX | N/A | powder · intravenous | TELIX | Prescription | 17 Dec 2021 |
| LOCAMETZ | N/A | powder · intravenous | NOVARTIS | Prescription | 23 Mar 2022 |
| GOZELLIX | N/A | powder · intravenous | TELIX INNOVATIONS | Prescription | 20 Mar 2025 |
| GALLIUM GA 68 GOZETOTIDE | 0.5-5mCi/ML | solution · intravenous | IONETIX | Prescription | 14 May 2026 |
| GALLIUM GA 68 GOZETOTIDE | 0.5-5mCi/ML | solution · intravenous | RADIOMEDIX | Prescription | 8 Jun 2026 |
Safety signals and safety-related labeling changes
- US FDA 28 Mar 2025 LOCAMETZ — safety-related labeling change
Labeling sections changed: Adverse Reactions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.