RadioMedix, Curium file NDA for PET agent

By staff writers

January 8, 2020 -- Biotechnology firm RadioMedix and global nuclear medicine firm Curium have filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for the firms' PET diagnostic radiopharmaceutical copper-64 (Cu-64) DOTATATE.

Cu-64 DOTATATE is a PET diagnostic agent designed to identify the somatostatin receptors of neuroendocrine tumors. The companies announced an exclusive agreement to develop and commercialize Cu-64 DOTATATE in 2018 and received fast-track designation from the FDA for the agent in January last year.

If approved, the agent will be the first Cu-64-labeled radiopharmaceutical for PET/CT imaging, the companies said.

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