NorthStar Medical Radioisotopes, of Beloit, Wis., has received approval from the the U.S. Food and Drug Administration for its RadioGenix System for production of the medical isotope technetium-99m.
A decay product of the isotope molybdenum-99 , technetium-99m is used for medical imaging for cancer, coronary artery disease, and health threats to the lungs, liver, kidneys, and brain. The United States has not had a domestic production source of molybdenum-99 for over a quarter-century, but several companies are racing to re-establish that capacity.
“Every day, tens of thousands of people in the U.S. undergo a nuclear medical imaging procedure that depends on Tc-99m,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a Feb. 8 press release. “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.”
The Department of Energy’s National Nuclear Security Administration provided some of the funding for development of the system, which uses stable isotopes instead of potentially weapon-usable enriched uranium.
In its own press release, NorthStar called its technology “a technetium Tc 99m generator used to produce sterile, non-pyrogenic Sodium Pertechnate Tc 99m Injection.” It said customers should receive the product in a matter of weeks after FDA approval.
The U.S. Nuclear Regulatory Commission, which oversees domestic use of radioactive substances in medicine, will submit guidance and the license allowing the technetium-99m from NorthStar’s system to be applied for medical purposes, the FDA said.
