Actinium-225 (Thorium-229 Derived) Drug Master File Accepted by the FDA
The DOE Isotope Program is pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted its Type II Drug Master File (DMF) submission for Actinium-225 Nitrate (thorium-229 derived). The alpha-emitting radionuclide and its decay product bismuth-213 have gained considerable interest within the medical community for targeted radiotherapy of cancer and other diseases.
The material is derived from thorium-229 stocks maintained at Oak Ridge National Laboratory. Ac-225 is one of the key radioisotopes that occur as the thorium decays. A byproduct from past nuclear programs, the thorium material is processed regularly to separate the Ac-225 for distribution. Due to the high demand for Ac-225, the quantity of Ac-225 available by this route is fully committed this year; however, the DOE IP is pursuing multiple other production routes for the isotope including accelerator-produced Ac-225.
A DMF is a confidential, detailed document that is submitted to the FDA with information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. An active DMF enables clinical investigators or pharmaceutical companies to reference the filing in their regulatory submissions.
For more information on this DMF, follow the link below to read the full article at ORNL.gov. If you have questions regarding Th-229 derived Ac-225, email firstname.lastname@example.org.