Isotope technology developer Eckert & Ziegler Radiopharma said it has received a recommendation from the European Medicines Agency for approval of its pharmaceutical gallium-68 generators.
The approval concludes a comprehensive evaluation procedure that led to the approval of the gallium generator for development of highly specific diagnostic agents, the company said, adding that it expects approval covering sales in the countries within the next month or two.
Gallium generators offer an inexpensive way to radiolabel diagnostic PET probes for imaging tissue necrosis, a process used principally in cancer treatment. The radioisotopes are produced using large-scale cyclotrons whose development is capital-intensive, Eckert & Ziegler said.
Upon receipt of final approval, the firm said it will also submit documentation to the U.S. Food and Drug Administration (FDA) to establish a drug master file with the agency that will allow parties interested in developing new drugs to reference the files and use the generator in clinical tests of medications and other products.
