NorthStar Medical Radioisotopes received approval from the U.S. Food and Drug Administration (FDA) the addition of two molybdenum-99 (Mo-99) filling lines at its facility in Columbia, Mo., the company announced today.
“FDA’s expedited review and approval of the additional filling lines in our Columbia, Mo., facility means an immediate increase in Mo-99 production efficiencies in Columbia,” NorthStar Medical Radioisotopes CEO Stephen Merrick said in a statement.
According to a release, NorthStar produces non-uranium based Mo-99 in collaboration with its manufacturing partner, the University of Missouri Research Reactor (MURR), using neutron capture technology.
The approval was made through expedited review of a Prior Approval Supplement to NorthStar’s original RadioGenix System New Drug Application, approved in 2018, for its Beloit, Wis., facility.