Navidea Biopharmaceuticals Resubmits New Drug Application for Lymphoseek® to FDA
Published: Oct 31, 2012
DUBLIN, Ohio--(BUSINESS WIRE)--Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced that on October 30, 2012 it filed the resubmission of its Lymphoseek® New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to the Complete Response Letter (CRL) received in September 2012. Lymphoseek (technetium Tc 99m tilmanocept) Injection 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.