Madison-based NorthStar Medical Radioisotopes received approval to begin routine production of molybdenum-99 (Mo-99) at the University of Missouri Research Reactor (MURR) facility in Columbia, Mo. The company will now be able to regularly operate its proprietary aliquoting system at the MURR site to fill source vessels with Mo-99, enabling the company to establish a weekly production schedule and increase its output of the vital medical radioisotope.
Mo-99 is the parent isotope of technetium-99m (Tc-99m), the most widely used radioisotope in medical diagnostic imaging. Currently, nearly all Mo-99 is generated using weapons-useable highly enriched uranium (HEU) at aging facilities located outside of the United States, leading to chronic product shortages and creating safety and national security concerns.
The next significant step in the regulatory approval process will be submission of a final amendment to NorthStar’s New Drug Application (NDA) with the FDA, which is expected to occur late this year.
