FDA OKs Covidien's LEU-based isotope production‎

Covidien ($COV) has received FDA approval for 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 used in diagnostic and functional studies of organs and anatomical systems. It will be supplied to hospitals and nuclear pharmacies by Covidien's Mallinckrodt business.

The approval 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.

The rare Mo-99 has a half-life of just 2.74 days and has been extremely hard to obtain since 2009 following the shutdown for repairs of the Canadian reactor that produced a third of the global supply, Mass Device reports. Later, a second reactor in the Netherlands also shut down for repairs. In March 2010, the company won clearance from the FDA and Health Canada to begin using a Polish nuclear reactor to supply Tc-99m.

Covidien is also developing plans for conversion of its Mo-99 processing facility in Petten, the Netherlands, to facilitate use of LEU, the company says in a statement.

- read the Covidien statement
- get more from Mass Device

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