FDA gives Covidien plant OK for rare medical isotope

The FDA approved a Covidien plc plant in Missouri for the manufacture of a rare medical isotope using a South African source.

The FDA gave Covidien plc (NYSE:COV) the go-ahead to begin making a rare medical isoptope at a plant in Marland Heights, Mo.

The Food & Drug Administration gave the Mansfield, Mass.-based medical products conglomerate permission to use molybdenum-99 from by South Africa's Nuclear Energy Corp. to make technetium-99.

Check out more of MassDevice's comprehensive coverage of Covidien

Molybdenum-99, which has a half-life of just 2.74 days and is very rare, got even scarcer in 2009 after the shutdown for repairs of the Canadian reactor that produced a third of the global supply in May 2009. Later, a second reactor in the Netherlands also shut down for repairs.

Tc-99m* is used in more than 80 percent of the more than 30 million nuclear medicine procedures performed worldwide each year, more than half in the U.S., according to Covidien.

In March 2010 the company won clearance from the FDA and its counterpart north of the border, Health Canada, to begin using a Polish nuclear reactor to supply technetium 99.

Billerica, Mass.-based Lantheus Medical Imaging Inc. is also in the rare isotope game, winning increased access to Mo-99 in May 2010 from the Nuclear Reactor Institute as part of a pact between the Institute for Radioelements in Fleurus, Belgium, and the Rez, Czech Republic-based Nuclear Research Institute. In July 2010, Lantheus arranged another new manufacturing and supply deal for Mo-99, with Ottawa-based MDS Nordion.

*Correction, March 14, 2011: This article originally referred to technetium-99 as Te99, rather than Tc99m (an important distinction because the Tc-99 isotope is not used medically). Return to the corrected sentence.