FDA accepts Navidea’s resubmitted NDA for Lymphoseek
Published on November 14, 2012 at 1:18 AM
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.
Navidea Biopharmaceuticals, Inc.