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Navidea Biopharmaceuticals (NAVB) Announces Priority Review For The sNDA To Expand Lymphoseek® Labeling For Sentinel Lymph Node Detection In Patients With Head And Neck Cancer


2/18/2014 8:06:49 AM

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DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Supplemental New Drug Application (sNDA) and granted a Priority Review for the expanded use of Lymphoseek® (technetium 99m tilmanocept) Injection indicated for sentinel lymph node (SLN) detection in patients with head and neck cancer. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target review date for the Lymphoseek sNDA of June 16, 2014. The FDA grants priority review status to drug applications that may offer a significant improvement in treatment over existing options. Lymphoseek is currently approved for use in lymphatic mapping procedures performed to aid in the diagnostic evaluation of lymph nodes draining a primary tumor in patients with breast cancer and melanoma.

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