US Approval for South Africa-Produced Medical Isotope based on Low-Enriched Uranium

The US Food and Drug Administration (FDA) has approved the use of molybdenum-99 (Mo-99) derived from low-enriched uranium (LEU) in the production of technetium-99m (Tc-99m) generators.

Tc-99m is a medical isotope, utilized in over 80% of all nuclear medicine imaging, supplied to hospitals and nuclear pharmacies by Covidien's (Dublin, Ireland) Mallinckrodt business. 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. (Pretoria, South Africa), a subsidiary of the Nuclear Energy Corp. of South Africa, in Tc-99m generator production at Covidien's Maryland Heights, MO, USA, manufacturing facility.

Tc-99m is an important medical isotope used in diagnostic and functional studies of organs and anatomic systems. The information from these studies is used by many medical specialists (including radiologists, cardiologists, nephrologists, and oncologists) to better diagnose and treat patients. More than 30 million nuclear medicine procedures are performed worldwide each year using Tc-99m, more than half in the United States.

"This FDA approval represents another step in our commitment to move toward LEU conversion in the production of Mo-99 and Tc-99m,” said Elaine Haynes, vice president and general manager, imaging, Americas.

In January 2009, Covidien launched a collaborative effort with Babcock & Wilcox Technical Services Group (B&W; Charlotte, NC, USA) 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.

Related Links:
Covidien
NTP Radioisotopes
Babcock & Wilcox Technical Services Group