FDA approves first American source for Tc-99m isotopes


FDA approves first American source for Tc-99m isotopes

Until the approval, the imaging tracer was only available from foreign suppliers, often limiting supplies of Tc-99m, which, according to the FDA, is used in more than 80 percent of nuclear imaging procedures in the USA, along with its parent element molybdenum-99.

The U.S. Food and Drug Administration announced today that it has approved a new technology to produce the country's own supply of the substance - a radioisotope called Technetium-99m, or Tc-99m.

"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 USA -based manufacturing capacity that is less vulnerable to supply disruptions", Gottlieb said in the statement.

A system for producing medically important technetium-99m isotopes within the US without relying on highly enriched uranium as source material won FDA approval Thursday, the agency announced. That's because all reactors that produced Tc-99m were in other countries, "creating a complicated, at times uncertain and potentially risky supply chain" that also was costly, he said.

The radioisotope plays a crucial role in nuclear imaging studies for a wide range of uses, including cancer and cardiology.

"While we needed to preserve the availability of Tc-99m for its important medical goal, it was critical that we find a more stable, secure and sustainable technology for production", Gottlieb said, and that's where the RadioGenix System came in.

The approval was granted to NorthStar Medical Radioisotopes in Beloit, Wisc.

According to the FDA's release, the U.S. Department of Energy has been working with the private sector to encourage domestic production of Molybdenum-99 (Mo-99) since Congress signed the American Medical Isotopes Production Act in 2012. "And today's approval will have an enduring benefit across the patient communities and toward strengthening our national security".