FDA Issues Complete Response Letter to NDA for Lymphoseek

Navidea Biopharmaceuticals announced that it received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application (NDA) for Lymphoseek (technetium Tc 99m tilmanocept) Injection.

In the CRL, the FDA noted the decision was focused on issues with third-party Lymphoseek contract manufacturing, and was not related to any efficacy or safety data filed within the Lymphoseek NDA.

Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help stage breast cancer and melanoma. 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.