News | July 08, 2009

Lantheus Gets FDA, Health Canada Approval for Australian-Supplied Mo-99

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

Related Content

Researchers Create New Method for Developing Cancer Imaging Isotopes

Prototype fluidic system for zirconium-89 purification. Image taken through a hot cell window at the Department of Radiology, University of Washington. Image courtesy of Matthew O’Hara, Pacific Northwest National Laboratory

News | Radiopharmaceuticals and Tracers | March 14, 2019
A team of researchers at the University of Washington announced they developed a new automated system for producing...
ImaginAb Enrolls First Patient in Phase II PET Agent Clinical Trial
News | Radiopharmaceuticals and Tracers | January 30, 2019
ImaginAb Inc. announced the enrollment of the first patient in the Phase II clinical trial of the company’s CD8+ T Cell...
MIM Software Inc. Receives FDA 510(k) Clearance for Molecular Radiotherapy Dosimetry
Technology | Nuclear Imaging | January 16, 2019
MIM Software Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for molecular radiotherapy...
University of Missouri Research Reactor First U.S. I-131 Supplier in 30 Years

MURR is the only supplier of I 131 in the United States and the first U.S. supplier since the 1980s. Image courtesy of University of Missouri

News | Radiopharmaceuticals and Tracers | November 13, 2018
The University of Missouri Research Reactor (MURR) recently shipped its first batch of Iodine-131 (I-131), a...
MEDraysintell Projects Increasing Mergers and Acquisitions in Nuclear Medicine
News | Nuclear Imaging | November 07, 2018
With the recent announcement by Novartis to acquire Endocyte , interest from the conventional pharmaceutical industry...
CORAR Supports Medicare Diagnostic Radiopharmaceutical Payment Equity Act of 2018
News | Radiopharmaceuticals and Tracers | October 12, 2018
October 12, 2018 — The Council on Radionuclides and Radiopharmaceuticals Inc.
PET Imaging Agent Predicts Brain Tau Pathology, Alzheimer's Diagnosis
News | PET Imaging | September 05, 2018
Eli Lilly and Co. and Avid Radiopharmaceuticals Inc. announced a Phase 3 study of positron emission tomography (PET)...
Abnormal Protein Concentrations Found in Brains of Military Personnel With Suspected CTE

Researchers are using the tracer, which is injected into a patient, then seen with a PET scan, to see if it is possible to diagnose chronic traumatic encephalopathy in living patients. In this image, warmer colors indicate a higher concentration of the tracer, which binds to abnormal proteins in the brain. Credit UCLA Health.

News | PET Imaging | August 24, 2018
August 24, 2018 — In a small study of
PET/CT Changes Care for 59 Percent of Suspected Recurrent Prostate Cancer Cases
News | Prostate Cancer | June 13, 2018
A recently presented investigational clinical trial evaluated the impact of 18F fluciclovine positron emission...
PET Imaging Agent Could Provide Early Diagnosis of Rheumatoid Arthritis

Coronal 18F-FEDAC PET/CT section of a mouse with collagen-induced arthritis. (A) On day 23 and day 37, increased uptake is noted in the front and hind paws of this mouse with collagen-induced arthritis. (B) Predictive performance of day 23 18F-FEDAC uptake for the development of clinical arthritis. ROC = receiver operating characteristic; Sn = sensitivity; Sp = specificity. Credit: Seoul National University and Ewha Womans University, Seoul, South Korea

News | PET Imaging | May 17, 2018
A novel positron emission tomography (PET) tracer developed by Korean researchers can visualize joint inflammation and...