FDA approves NDA for sodium fluoride F18 injection

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The FDA has approved a new drug application (NDA) for use of a new strength of a previously approved drug, sodium fluoride F18 (18F-NaF) injection, in bone scans. The National Cancer Institute and the National Institutes of Health submitted the NDA.

Knoxville, Tenn.-based PETNet Solutions, a wholly-owned subsidiary of Siemens Healthcare, is the only manufacturer included in the NDA for 18F-NaF injection at this time.

PETNet said this could increase its radiopharmaceutical manufacturing and distribution capabilities, and lays the foundation for manufacturing of new molecular imaging biomarkers as they are commercialized. The company operates a network of PET radiopharmaceutical production facilities with 54 production and distribution centers globally.