On January 6, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radiopharmaceuticals used for medical imaging and therapeutic treatments, reported that the U.S. Food and Drug Administration (FDA) has approved its application for producing Mo-99 from concentrated Mo-98 (cMo-98) and related software updates for the RadioGenix System (technetium Tc 99m generator) (Press release, NorthStar Medical Radiostopes, JAN 6, 2021, View Source [SID1234573580]). Processing of cMo-98 targets increases production capacity of the important medical radioisotope, molybdenum-99 (Mo-99), up to four times above that of current NorthStar technology, and enables NorthStar to provide customers with higher activity source vessels, which will support enhanced radiopharmacy efficiencies. FDA approval was granted through a Prior Approval Supplement (PAS) to NorthStar’s original RadioGenix System (technetium Tc 99m generator) New Drug Application, which was approved in 2018. The RadioGenix System is an innovative, high tech radioisotope separation platform for use in producing the widely used medical radioisotope technetium-99m (Tc-99m) from domestically-produced, non-uranium based Mo-99. NorthStar expects to begin shipments of larger capacity, multi-sized source vessels to customers in the coming days.
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"NorthStar, and its partners at the University of Missouri Research Reactor (MURR), are proudly leading the way as the only commercialized producer of Mo-99 in the United States," said Stephen Merrick, President and Chief Executive Officer of NorthStar. "This approval of production utilizing cMo-98 and the related RadioGenix System software updates is a transformational event for NorthStar Medical Radioisotopes and a key milestone in significantly increasing domestic production and capacity of non-uranium based Mo-99 for the United States. It enables a near four-fold increase in U.S. Mo-99 production capacity for NorthStar to meet customer demand. The ability to provide our customers with a range of higher activity source vessels (7.5 Ci, 12 Ci, 15 Ci and 19 Ci) will help drive efficiencies in radiopharmacy operations and patient access to Tc-99m, which informs more than 40,000 U.S. healthcare decisions daily. To further maximize radiopharmacy efficiencies, and unique to the industry, NorthStar can now also provide a 21-day expiration for our Mo-99 source vessels and a 24-hour Beyond Use Date (BUD) for Tc-99m generated using the RadioGenix System. In conjunction with this approval, we also wish to recognize the important support that our partners at MURR, with whom we jointly produce Mo-99 in Columbia, Mo., have had in helping to progress cMo-98 development."
Mr. Merrick continued, "We continue to successfully deliver on our Mo-99 production plans and RadioGenix System enhancement roadmap, with this cMo-98 approval marking the fifth FDA approval for the RadioGenix System and non-uranium-based Mo-99 production since 2018. The RadioGenix System is changing the way that radiopharmacies plan for having reliable, domestic Mo-99 supply on time and when needed. We are pleased to note that NorthStar has now achieved two years of reliable commercial production. Our active expansion to ensure continued, reliable domestic Mo-99 supply through establishing dual production and processing hubs for additional capacity and scheduling flexibility remains on track. Equipment installation, testing and qualification is proceeding on schedule, and upon appropriate licensure and FDA approval, our Isotope Processing facility in Beloit, Wis., will augment current processing in Columbia, Mo. Our Accelerator Production facility construction in Beloit, which will enable additional production of Mo-99 using "neutron knock-out" technology continues on track, with the initial pair of accelerators undergoing final testing prior to shipment to the United States, where we expect them to be installed in early 2021."
"NorthStar is the first company to deploy innovative cMo-98 technology for radioisotope production on a commercial scale," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar. "The process uses natural molybdenum, which is approximately 24% Mo-98, that has been concentrated to be up to 98% Mo-98 (cMo-98), to produce Mo-99 using neutron capture technology."
About the RadioGenix System (Technetium Tc 99m Generator)
The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium based molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.
Indication and Important Risk Information about the RadioGenix System and Sodium Pertechnetate Tc 99m Injection USP
The RadioGenix System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.
Sodium Pertechnetate Tc 99m Injection is also indicated in
Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.
IMPORTANT RISK INFORMATION
Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.
Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.
Unintended Re-186 Exposure: Discard the first eluate from every new Potassium Molybdate Mo-99 Source Vessel to minimize the risk of unintended radiation exposure from Rhenium Re-186.
Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.
Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.
Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kit/packs, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 24 hour expiration time from elution is reached, whichever occurs earlier.