After Canada’s Chalk River reactor was taken offline in May 2009 for more than a year due to a heavy water leak, medical radioisotope suppliers have been looking to expand their sources. Covidien, having received FDA approval a year ago to source molybdenum-99 from Poland’s Maria nuclear research reactor, has now received similar clearance to purchase molybdenum-99 derived from low-enriched uranium from a South African reactor. Molybdenum-99 is used to generate technetium-99m, the radiomarker most commonly used in nuclear medicine.
Tc-99m is produced when Mo-99 decays following uranium irradiation. The approval by the FDA allows use of LEU-based Mo-99 supplied by South Africa’s NTP Radioisotopes, Ltd., a subsidiary of the Nuclear Energy Corporation of South Africa, in Tc-99m generator production at Covidien’s Maryland Heights, MO, manufacturing facility.
In January, 2009, the Company launched a collaborative effort with Babcock & Wilcox Technical Services Group (B&W) to develop solution-based reactor technology for LEU-based medical isotope production, a unique approach designed to provide an efficient domestic supply source. The project combines Covidien’s expertise in radiopharmaceutical production and global regulatory approvals with B&W’s patented liquid phase nuclear technology. Covidien is also developing plans for conversion of its Mo-99 processing facility in Petten, the Netherlands, to facilitate use of LEU.
Press release: Covidien Receives FDA Approval for South African-Produced Medical Isotope Based on Low-Enriched Uranium
Flashbacks: New Radioisotope Supplier to Fill Gaping Hole in Market; Project Aims for Medical Isotope Production Without Use of Nuclear Reactors