FDA, Health Canada greenlight Lantheus' Mo-99 from Australia

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Lantheus Medical Imaging has been granted a supplemental new drug application (sNDA) from the FDA and a supplemental new drug submission (SNDS) from Health Canada to qualify the Australian Nuclear Science and Technology Organization (ANSTO) as a valid supplier for low-enriched uranium (LEU)-derived molybdenum-99 (Mo-99) to the United States and Canada.

Mo-99 is the parent isotope of technetium-99m (Tc-99m), the most widely used medical radioisotope for molecular and nuclear diagnostic imaging procedures.

The North Billerica, Mass.-based Lantheus said the approval notification from the FDA and Health Canada were received within a one-week timeframe of Lantheus' filing of the sNDA and SNDS applications, respectively.

With these approvals, Lantheus said it will offer Tc-99m using Mo-99 derived from LEU targets. The LEU-derived Mo-99 has been tested and validated by Lantheus for use in its TechneLite generator line to ensure consistency and reliability, the firm said.