Navidea Biopharma Says PDUFA Goal Date for Lymphoseek April 30, 2013Paul QuintaroBenzinga
Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical companyfocused on precision diagnostic radiopharmaceuticals, announced today that theU.S. Food and Drug Administration (FDA) has accepted the filing of theCompany's October 30, 2012 resubmission of its New Drug Application (NDA) forLymphoseek (Technetium Tc 99m Tilmanocept) Injection. In its acknowledgment,FDA noted that it considers the filing a complete, class 2 response to itsSeptember 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 inlymphatic mapping procedures that are performed to help stage cancer.Lymphoseek is designed to identify the lymph nodes that drain from a primarytumor, which have the highest probability of harboring cancer.(c) 2012 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.