FDA Accepts Resubmitted NDA for Lymphoseek
Navidea Biopharmaceuticals announced that the 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. Lymphoseek is a novel, receptor-targeted, small-molecule, investigational radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage cancer.
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 designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.For more information call (800) 793-0079 or visit www.navidea.com.