NorthStar’s recent FDA approval enables a fourfold increase in Mo-99 production

Nuclear medicine firm NorthStar Medical Radioisotopes on Wednesday received federal approval for its new molybdenum-99 application that enables a nearly fourfold increase in the production of Mo-99.

The U.S. Food & Drug Administration’s greenlight specifically applies to NorthStar’s process of producing Mo-99 from concentrated molybdenum-98 (cMo-98). The former radioisotope is crucial for developing radiotracers used in medical imaging exams.

This marks the first and only commercial-scale application of cMo-98 technology, according to the Beloit, Wisconsin-based company.

The FDA also approved updates to NorthStar’s RadioGenix System, which is used to produce technetium-99m (Tc-99m) and required for generating Mo-99.

“This approval of production utilizing cMo-98 and the related RadioGenix System software updates is a transformational event for NorthStar Medical Radioisotopes and a key milestone in significantly increasing domestic production and capacity of non-uranium based Mo-99 for the United States,” President and CEO Stephen Merrick said in a statement.

NorthStar first partnered with the University of Missouri Research Reactor, or MURR, to begin producing Mo-99 in Columbia, Missouri. Merrick specifically thanked the facility for its help in the process.