FDA approves Axumin (fluciclovine (18F)) for PET imaging of suspected recurrent prostate cancer.- Blue Earth Diagnostics Ltd
The FDA has approved Axumin (fluciclovine (18F)), a radioactive diagnostic agent for injection from Blue Earth Diagnostics Ltd. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated prostate specific antigen (PSA) levels following prior treatment.
Distributor in the US is Siemens’ PETNET Solutions, Inc.
Blue Earth Diagnostics has in March 2016 submitted an application to the European Medicines Agency (EMA) for an EU/EEA marketing authorisation for fluciclovine (18F) for lesion detection and localisation for prostate cancer patients experiencing biochemical recurrence.
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