The FDA and Nuclear Regulatory Commission today approved NorthStar Medical Radioisotopes‘ RadioGenix system designed to produce Technetium-99m, which it said is the most widely used radioisotope in medical imaging.
Guidance from the NRC, an independent agency created by congress to license and regulate the civilian use of radioactive materials, was issued to allow the system to produce the Tc-99m for medical purposes.
With the guidance, the RadioGenix system is cleared 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.
The RadioGenix system was created through a collaboration between the federal government and the industry.
“Every day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m. This radioisotope is vital to disease detection, yet health care professionals have faced challenges with adequate supply due to a complex supply chain that sometimes resulted in shortages. Today’s approval has been the result of years of coordination across the FDA and with U.S. government organizations and marks the first domestic supply of Mo-99 – the source of Tc-99m – in 30 years, which will help to ensure more reliable, clean and secure access to this important imaging agent used in nuclear medicine,” FDA Center for Drug Evaluation and Research director Dr. Janet Woodcock said in a press release.
“The system we’ve approved today will not only help save and improve the lives of patients, but will reduce the risk of drug shortages and strengthen our national security by creating a U.S.-based manufacturing capacity that is less vulnerable to supply disruptions. Prior to today, the production process for Tc-99m involved shipping enriched uranium out of the U.S. for irradiation. All of the reactors that produced this source material were located outside of the U.S. creating a complicated, at times uncertain, and potentially risky supply chain. These foreign facilities were vulnerable to unforeseen shutdowns or closures, imperiling the U.S. supply. Additionally, shipping enriched uranium out of the U.S., and shipping materials back (in the form of Molybdenum-99, or Mo-99) was expensive,” FDA head Dr. Scott Gottlieb said in a prepared release.