BWXT Medical submits Tc-99m generator application to FDA

September 14, 2022, 3:02PMNuclear News

BWXT Medical has submitted a new drug application to the U.S. Food and Drug Administration to request approval of its technetium-99m generator for medical imaging. A daughter isotope of molybdenum-99, Tc-99m is used in more than 40 million diagnostic procedures annually. BWXT Medical is a subsidiary of Lynchburg, Va.-based BWX Technologies.

If approved for commercial production by regulatory bodies, the new technology will be used to irradiate molybdenum targets at an Ontario Power Generation reactor (to be named later) and to process Mo-99. Subsequently, the material will be incorporated into Tc-99m generators at BWXT Medical’s Kanata, Ontario, facility for delivery to radiopharmacies and hospitals across the United States and Canada.

The process: Historically, Mo-99 has been produced by research reactors using uranium as a starting material. Alternatively, BWXT's Tc-99m will be produced from natural molybdenum targets irradiated at a commercial power reactor, which the company says will greatly reduce complex waste by-products. The molybdenum targets will be processed into the finished active pharmaceutical ingredient and then loaded into generators that have the function and form of generators already used at radiopharmacies and hospitals today.

“We are excited to reach this key milestone for BWXT Medical, putting us one step closer toward our aspiration of global leadership in nuclear medicine manufacturing,” said Rex D. Geveden, BWXT’s president and chief executive officer. “Our Tc-99m generator product is a lower cost, more reliable, drop-in replacement to current generators, and we see it as a key component of our medical portfolio.”

Business strategy: BWXT Medical has published an investor presentation highlighting the company’s Tc-99m generator strategy, its growing nuclear medicine product portfolio, and future opportunities in therapeutic radioisotopes. The presentation can be found here.

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