Orphan Designation: For use in sentinel lymph node
Post# of 47
Posted On: 09/18/2014 3:04:43 PM
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
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
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