July 9, 2009 - The U.S. Food and Drug Administration (FDA) and Health Canada have approved the Lantheus Medical Imaging Inc.’s supplemental New Drug Application (sNDA) for FDA and Supplemental New Drug Submission (SNDS) for Health Canada to qualify the Australian Nuclear Science and Technology Organisation (ANSTO) as a valid supplier for low-enriched uranium (LEU)-derived molybdenum-99 (Mo-99) in the United States and Canada, respectively.
Both the FDA and Health Canada sent approval notifications within a one-week timeframe of Lantheus’ filing of the sNDA and SNDS applications, respectively. The expedited approvals emphasize the urgent need for a reliable supply of the Mo-99 isotope for diagnostic imaging.
Lantheus will be the first U.S. company to offer technetium-99m (Tc-99m) using Mo-99 derived from LEU targets to the U.S. and Canada. Lantheus anticipates receiving regular supply from ANSTO within the next several weeks for use in its TechneLite generator line that is currently distributed to the U.S. and Canadian markets. The LEU-derived Mo-99 has been tested and validated by Lantheus for use in its TechneLite generator line to ensure the consistency and reliability that are the hallmarks of the TechneLite brand.
For more information: www.lantheus.com