Covidien has received approval from the U.S. Food and Drug Administration (FDA) to use molybdenum-99 (Mo-99) from a South African firm for the production of technetium-99m generators at its Maryland Heights, MO, manufacturing facility.
The FDA cleared Covidien to use molybdenum-99 from NTP Radioisotopes, a subsidiary of the South African Nuclear Energy Corporation (NECSA). NTP's Mo-99 is derived from a low-enriched uranium (LEU) method, in which Mo-99 decays into technetium-99m following uranium irradiation.
Radioisotope producers are investigating LEU production of Mo-99 as an alternative to using highly enriched uranium, which requires the use of a nuclear reactor. Supplies of Mo-99 were severely constrained in 2009 and 2010 after the shutdown of several nuclear reactors that provide much of the world's supply of the radioisotope.
Covidien said the FDA approval represents another step in the company's commitment to move toward LEU conversion for producing Mo-99 and technetium-99m, which is used in more than 80% of all nuclear medicine studies. Covidien supplies the radioisotope to hospitals via its Mallinckrodt business.
Covidien is also pursuing the development of a U.S.-based source of medical isotope production based on LEU technology through a collaboration with Babcock & Wilcox Technical Services Group. Covidien also plans to convert its Mo-99 processing facility in Petten, the Netherlands, to facilitate the use of LEU.
