On January 7, 2020 RadioMedix Inc. and its commercial partner Curium reported that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA) (Press release, RadioMedix, JAN 7, 2020, View Source [SID1234552785]). Copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection.

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"If approved, we expect that copper Cu 64 dotatate injection will be the first FDA approved Cu 64 labeled radiopharmaceutical for PET/CT imaging. In addition, this drug will provide an exciting new imaging agent for NET physicians, patients and caregivers," said Ebrahim Delpassand, MD, CEO of RadioMedix. "Copper Cu 64 dotatate injection will be the first neuroendocrine PET diagnostic agent available to all medical centers with PET capability across the country. This will alleviate the scheduling and supply challenges many geographies have experienced with other somatostatin analogue PET agents. We are currently pursuing a Priority Review with the FDA to expedite commercial availability."

"If approved, the clinical utility of this new agent will allow Curium to enhance patient care in the U.S. by bringing the accuracy of PET SSTR to all hospitals and imaging centers," said Curium CEO, North America, Dan Brague. "Our ability to manufacture copper Cu 64 dotatate injection at a central location and distribute quantities to meet the needs of hospitals and imaging centers demonstrates our continued focus on patients with neuroendocrine tumors. We are excited to be bringing Cu 64, an exciting new isotope for PET imaging, to the market. We look forward to exploring additional applications that can help patients and physicians."