NorthStar Medical Radioisotopes has garnered U.S. Food and Drug Administration (FDA) approval for additional molybdenum-99 (Mo-99) filling lines at its Columbia, MO, facility, paving the way for increased production of the isotope, which is a precursor to technetium-99m.
The FDA approved the additional filling lines via an expedited view of a prior approval supplement to the original new drug application for the company's RadioGenix system, which was approved in 2018.
NorthStar produces nonuranium-based Mo-99 at the Columbia site in collaboration with the University of Missouri Research Reactor.
