NorthStar gets FDA nod to produce Mo-99 from cMo-98

By staff writers

January 6, 2021 -- NorthStar Medical Radioisotopes has received U.S. Food and Drug Administration (FDA) approval to produce molybdenum-99 (Mo-99) from concentrated molybdenum-98 (cMo-98).

The company's process enables a fourfold increase in the production of Mo-99, a precursor to technetium-99m (Tc-99m). This is the first and only commercial-scale application of the cMo-98 technology, according to the company.

Technetium-99m is a radiotracer that's widely used in nuclear medicine, such as for cardiac SPECT studies of heart function. The industry's ability to supply technetium-99m is frequently strained by interruptions in Mo-99 production, making it desirable to develop new sources for the radioisotope.

The FDA also approved related software updates for NorthStar's RadioGenix radioisotope separation system, which is used to produce Tc-99m. NorthStar expects to begin shipments of larger capacity, multisized source vessels to customers in the near future.

Copyright © 2021

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