DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the US Food and Drug Administration (FDA) has granted Fast Track designation to Lymphoseek® (technetium 99m tilmanocept) Injection for sentinel lymph node detection in patients with head and neck cancer. Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. Navidea intends to file the supplemental New Drug Application (sNDA) for Lymphoseek before year-end. Lymphoseek was approved by the FDA in March 2013 for use in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma.
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