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 filing of the
Company's October 30, 2012 resubmission of its New Drug Application (NDA) for
Lymphoseek (Technetium Tc 99m Tilmanocept) Injection. In its acknowledgment,
FDA noted that it considers the filing a complete, class 2 response to its
September 10, 2012 action letter and has set a Prescription Drug User Fee Act
(PDUFA) goal date of April 30, 2013. Lymphoseek ^ is a novel,
receptor-targeted, small-molecule, investigational radiopharmaceutical used in
lymphatic mapping procedures that are performed to help stage cancer.
Lymphoseek is designed to identify the lymph nodes that drain from a primary
tumor, which have the highest probability of harboring cancer.
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