FDA clears Covidiens low-enriched uranium based isotope production

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The FDA has approved Covidien’s production of technetium-99m (Tc-99m) derived from the low-enriched uranium molybdenum-99 (Mo-99) isotope.

The approval allows NTP Radioisotopes, located in Pretoria, South Africa, to provide Covidien with the low-enriched uranium-based Mo-99 for generator production of Tc-99m at Covidien’s Maryland Heights, Mo. manufacturing facility. The deal helps Covidien press forward with its partner, Charlotte, N.C.-based Babcock & Wilcox Technical Services Group, to produce low-enriched uranium medical isotopes, which Covidien hopes will provide an efficient domestic supply.

Tc-99m, utilized in more than 30 million nuclear medicine procedures around the world each year (more than half of which occur in the U.S.), is produced when Mo-99 decays following uranium irradiation. Covidien, based in Dublin, said it is also planning to convert another of its Mo-99 processing facilities, this one in Petten, the Netherlands, to facilitate the use of low-enriched uranium.