The companies have completed a phase III clinical trial of the agent, which is being evaluated for the detection of neuroendocrine tumors. They expect to file a new drug application (NDA) with the FDA this year.
Curium and RadioMedix announced an exclusive agreement to develop and commercialize Cu-64 DOTATATE in August 2018.
The FDA's decision "highlights the public health need by enhancing the availability of diagnostic radiopharmaceuticals for patients with neuroendocrine tumors," said Dr. Ebrahim Delpassand, CEO of RadioMedix, in a statement. "This will address the shortage or lack of availability of somatostatin analogue PET agents that many geographies in the U.S. are experiencing."
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