October 31, 2012
NDA Resubmitted for Lymphoseek for ILM
Navidea Biopharmaceuticals announced that it has resubmitted the New Drug Application (NDA) for Lymphoseek (technetium Tc 99m tilmanocept) Injection to the FDA in response to the Complete Response Letter (CRL) received in September 2012.
Lymphatic mapping is a procedure in which lymph nodes that may contain tumor metastases are identified and biopsied to determine if cancer has spread beyond the primary tumor.
Lymphoseek 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, in patients with breast cancer or melanoma.
For more information call (800) 793-0079 or visit www.navidea.com.