Lymphoseek Approval History

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

Lymphoseek (technetium Tc 99m tilmanocept) Injection is a radioactive diagnostic agent indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.

FDA Approval History for Lymphoseek

Date	Article
Mar 13, 2013	FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers
Nov 13, 2012	Navidea Biopharmaceuticals Announces PDUFA Goal Date for Lymphoseek New Drug Application Resubmission
Nov  2, 2012	Navidea Biopharmaceuticals Resubmits New Drug Application for Lymphoseek to FDA
Sep 19, 2012	Navidea Biopharmaceuticals Receives Complete Response Letter from FDA for Lymphoseek NDA Due to Manufacturing Deficiencies

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Lymphoseek (technetium Tc 99m tilmanocept) Consumer Information

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