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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: technetium Tc 99m tilmanocept
Trade Name: LYMPHOSEEK
Date Designated: 09/17/2014
Orphan Designation: Use in sentinel lymph node detection (SLN) with a hand-held gamma-counter, with scintigraphic imaging, in patients with cancer of the head and neck
Orphan Designation Status: Designated/Approved
Cardinal Health 414, LLC
7200 Cardinal Pl
Dublin, Ohio 43017
United States

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

Marketing approved:

1 Generic Name: technetium Tc 99m tilmanocept
Trade Name: LYMPHOSEEK
Marketing Approval Date: 06/13/2014
Approved Labeled Indication: Guiding sentinel lymph node biopsy, using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
Exclusivity End Date: 06/13/2021 
Exclusivity Protected Indication* :  Guiding sentinel lymph node biopsy, using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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