“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,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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 NRC will issue guidance advising medical and commercial nuclear pharmacy users on the license amendments required to use the RadioGenix System. Production of Mo-99 will initially be carried out in Columbia, Missouri by NorthStar employees and MURR employees.

The system is approved for the production of Sodium Pertechnetate Tc-99m injection that can be administered intravenously into the bladder or eye, and can be used with other FDA-approved imaging drugs to examine specific tissues and organs.

Approval was not subject to new clinical studies as it relied on safety and efficacy information and data from an FDA-approved Tc-99m generator. Partial funding for it was provided by the U.S. Department of Energy’s National Nuclear Security Administration.

NorthStar expects to begin shipping out the product within the next several weeks.

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