NorthStar Medical Radioisotopes said today it won FDA approval for its Beloit, Wisc.-based manufacturing facility to begin producing its RadioGenix system and associated materials.
The approval was made through a Prior Approval Supplement to the company’s recently approved RadioGenix system new drug application 202158, NorthStar said, and serves as the first step in expanding its Beloit manufacturing facilities.
“NorthStar has quickly achieved several key milestones in advancing our strategically planned RadioGenix System roll-out. First, the FDA approval of our Beloit manufacturing facility enables us to scale up production and expand capacity to meet anticipated customer demand. The approval came well in advance of the anticipated FDA action date. Second, we are also very pleased to announce that the commercial launch of the RadioGenix System has commenced, with the first contract signed and the first installation scheduled at a customer site. This important event marks another milestone in NorthStar’s commitment to provide the United States healthcare system with a reliable, domestic non-uranium based Mo-99 supply for production of the important medical diagnostic imaging radioisotope, technetium-99m. We anticipate shipping additional RadioGenix Systems as potential customers receive licensing amendments for their sites, and look forward to sharing our progress,” chair & CEO George Messina said in prepared remarks.
NorthStar said that in addition to the manufacturing approval, it initiated a commercial launch of its RadioGenix system.
“FDA approval for manufacturing in Beloit, Wis., means that NorthStar now has the capability to scale up and expand our RadioGenix manufacturing volume four-fold. The cGMP facility houses the manufacturing and quality control operations required to produce RadioGenix Systems, consumable kits and spare parts. Also, as recently announced, we have begun construction of additional manufacturing space for activities related to the processing of Mo-99, the material used by the RadioGenix System to generate the medically important isotope Tc-99m,” prez & COO Stephen Merrick said in a press release.
In February, NorthStar won clearance for its RadioGenix system to produce sodium pertechnetate Tc-99m to be injected intravenously, instilled into the bladder or eye or used with other FDA approved imaging drugs, the NRC said.