Lantheus Medical Imaging of North Billerica, MA, has won approval from the U.S. Food and Drug Administration (FDA) and Health Canada to offer technetium-99m (Tc-99m) in the U.S. and Canada.
The company submitted a supplemental new drug application to the FDA and Health Canada to qualify the Australian Nuclear Science and Technology Organisation (ANSTO) as a valid supplier for molybdenum-99 derived from low-enriched uranium in the U.S. and Canada. Molybdenum-99 is the parent isotope of Tc-99m.
Lantheus anticipates regular supply from ANSTO within the next several weeks for use in its TechneLite generator line, the company said.
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