Covidien (NYSE:COV) won clearance from the Food & Drug Administration and its counterpart north of the border, Health Canada, to begin using a Polish nuclear reactor to supply a scarce medical isotope.
The Mansfield, Mass.-based medical products conglomerate can start using molybdenum 99 from the Polish Institute of Atomic Energy’s Maria reactor to make technetium 99, which is used in imaging procedures.
Covidien said it expects to have Te99 from the Polish reactor on the market in the U.S. and Canada later this month. The isotope from the Polish reactor is already available in Europe. Covidien spokesman John Gillespie told MassDevice that the approvals mean the company can sell in the U.S., Canada and Europe Te99 derived from Mo99 made by any of the four reactors currently producing the isotope.
Covidien inked the deal with Polish authorities last month, prompted by the imminent shutdown of a Dutch reactor and the closure of a Canadian reactor last year. At the time, the company said the deal would help “meet the needs of more than one million additional patients” in the six months following the first use of the Polish Mo 99.
The company is the second with roots in the Bay State to seek to alleviate the Mo 99 shortage, following Billerica-based Lantheus Medical Imaging Inc.’s arrangement last summer with an Australian reactor to import the isotope.