News | Radiopharmaceuticals and Tracers | October 02, 2015

Siemens’ PETNET Solutions Receives ANDA Approval for 18F Sodium Fluoride

Ninety-nine percent of U.S. population will have access to PET radiopharmaceutical for bone imaging

Siemens PETNET Solutions, 18F NaF, ANDA approval, PET radiopharmaceutical

Image courtesy of Siemens Healthcare

October 2, 2015 — Siemens’ PETNET Solutions has received Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) to manufacture and distribute sodium fluoride F 18 injection (18F NaF) across its entire national network of radiopharmacies. The approval for the positron emission tomography (PET) radiopharmaceutical will provide coverage to 99 percent of the U.S. population.

18F NaF is indicated for PET bone imaging to define areas of altered osteogenic activity in the body, including metastatic bone disease from cancer. Multiple clinical studies have demonstrated improved sensitivity and specificity of PET/computed tomography (PET/CT) imaging compared to single-photon emission computed tomography (SPECT)/planar bone imaging. Early identification of patients at higher risk for developing bone metastases enables practitioners to be proactive in their diagnosis and treatment.

PETNET Solutions is a wholly owned subsidiary of Siemens Healthcare.

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