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NorthStar Medical Radioisotopes Announces FDA Approval for Enhanced U.S. Mo-99 Radioisotope Production Capacity

NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radiopharmaceuticals used for medical imaging and therapeutic treatments, announced 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). 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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Source: NorthStar