Isotope technology firm Eckert & Ziegler received approval from the Federal Institute for Drugs and Medical Devices for its pharmaceutical germanium-68 (Ge-68)/gallium-68 (Ga-68) generator for the German market.
It is the first approved generator to use a radionuclide for PET in the diagnosis of cancer and meets the requirements for pharmacopoeia monographs, according to the firm.
Gallium generators provide an inexpensive alternative for radiolabeling biomolecules using PET. Until now, fluorine-18 or carbon-11 radioisotopes have generally been used to radiolabel biomolecules; the radioisotopes are produced using cyclotrons, large-scale installations that require millions in investment, according to Eckert & Ziegler. The Ge-68/Ga-68 generator is approximately the size of a thermos and can be sourced much more inexpensively, the firm added.
Eckert & Ziegler has submitted its documents for the generator to the U.S. Food and Drug Administration, establishing a Drug Master File with the agency. Approval for sale in additional European countries has already been granted.