Covidien has received the US Food and Drug Administration (FDA) approval for the use of medical isotope molybdenum-99 (Mo-99) derived from low-enriched uranium (LEU) in the production of technetium-99m (Tc-99m) generators.
Tc-99m is utilized in over 80% of all nuclear medicine studies, supplied to hospitals and nuclear pharmacies by Covidien‘s Mallinckrodt business.
The approval by the FDA allows use of LEU-based Mo-99 supplied by South Africa’s NTP Radioisotopes, a subsidiary of the Nuclear Energy Corporation of South Africa, in Tc-99m generator production at Covidien’s Maryland Heights, MO, manufacturing facility.
Tc-99m is a critical medical isotope used in diagnostic and functional studies of organs and anatomical systems.
The information from the studies is used by many medical specialists (including radiologists, cardiologists, nephrologists and oncologists) to better diagnose and treat patients.