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Lymphoseek FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 6, 2021.

FDA Approved: Yes (First approved March 13, 2013)
Brand name: Lymphoseek
Generic name: technetium Tc 99m tilmanocept
Dosage form: Injection
Company: Navidea Biopharmaceuticals
Treatment for: Diagnosis and Investigation

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management.
  • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Development Timeline for Lymphoseek

DateArticle
Jun 10, 2021Approval  Cardinal Health Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New Lymphoseek Pediatric Indication
Jun 13, 2014Approval  FDA Approves Lymphoseek to Help Determine the Extent of Head and Neck Cancer in the Body
Mar 13, 2013Approval  FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers
Nov 13, 2012Navidea Biopharmaceuticals Announces PDUFA Goal Date for Lymphoseek New Drug Application Resubmission
Nov  2, 2012Navidea Biopharmaceuticals Resubmits New Drug Application for Lymphoseek to FDA
Sep 19, 2012Navidea Biopharmaceuticals Receives Complete Response Letter from FDA for Lymphoseek NDA Due to Manufacturing Deficiencies

Further information

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