June 7, 2016 — Blue Earth Diagnostics Ltd. and Siemens’ PETNET Solutions Inc. announced the commercial availability of Axumin (fluciclovine F-18) injection in the United States. Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment.
Axumin was approved by the U.S. Food and Drug Administration (FDA) on May 27, 2016, and is the first FDA-approved F-18 PET imaging agent indicated for use in patients with suspected recurrent prostate cancer.
Axumin will be commercially available through Siemens’ PETNET Solutions, Blue Earth Diagnostics’ manufacturer and exclusive commercial distributor in the United States. Initial commercial production of Axumin will be underway at certain Siemens’ PETNET Solutions radiopharmacies, with increasingly broader availability planned in the coming months.