Siemens’ PETNET Solutions announced last week it has received Abbreviated New Drug Application (ANDA) approval from the Food and Drug Administration for its PET radiopharmaceutical sodium fluoride F 18 injection (18F NaF).
The ANDA approval means PETNET Solutions can now proceed with manufacturing and distributing 18F NaF across its network of radiopharmacies in the U.S.
18F NaF is indicated for “bone imaging to define areas of altered osteogenic activity, including metastatic disease from cancer,” according to a statement from Siemens.
PETNET Solutions is a wholly owned subsidiary of Siemens Healthcare.
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