Monday, December 20, 2021

DOE, FDA Announce Sufficient Mo-99 Medical Isotope Supply for Medical Diagnostic Procedures - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

DOE, FDA Announce Sufficient Mo-99 Medical Isotope Supply for Medical Diagnostic Procedures

The Radiopharmaceutical Supply Work Group within the FDA's Center for Drug Evaluation and Research (CDER) has been working with the Department of Energy (DOE) and DOE's National Nuclear Security Administration to achieve a stable domestic supply of the medical isotope molybendum-99 (Mo-99), which is essential to create drugs for medical diagnostic procedures.

Today, DOE announced the national supply of Mo-99 can now meet demand, and the U.S. no longer has to rely on international partners to process highly enriched uranium to produce Mo-99 for domestic use. CDER's work to approve new drugs and production methods for Mo-99 has been instrumental in achieving this milestone. Starting in 2011, these new methods modernized more than six decades of commercial production technology, meeting domestic supply needs without using highly enriched uranium. We are excited to share the DOE's announcement with our stakeholders at FDA.

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