Orphan Designation: For use in sentinel lymph node detection with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck
Orphan Designation Status: Designated



Generic Name: technetium Tc 99m tilmanocept injection
Trade Name: Lymphoseek
Date Designated: 09-17-2014
Orphan Designation: For use in sentinel lymph node detection with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Navidea Biopharmaceuticals
5600 Blazer Parkway, Suite 200
Dublin, OH 43017

The sponsor address listed is the last reported by the sponsor to OOPD.


http://www.accessdata.fda.gov/scripts/opdlist...ber=427814