Is Gallium approved by the US FDA?

Drugs@FDA lists 1 application product line for Gallium, including GANITE (Discontinued).

Is Gallium authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 1 product containing Gallium, including GALLIAD, 0.74 -1.85 GBQ, RADIONUCLIDE GENERATOR.

Active substance

Gallium

US FDA 1
UK MHRA 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
GANITE	25MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	CHAPTER 7 TRUSTEE	Discontinued	17 Jan 1991

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
GALLIAD, 0.74 -1.85 GBQ, RADIONUCLIDE GENERATOR	PL 43883/0001	IRE ELIT SA	POM

Combinations containing Gallium

Gallium + germanium

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.