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Lymphoseek Approval History

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 for lymphatic mapping in patients with breast cancer or melanoma, and for guiding sentinel lymph node biopsy in patients with squamous cell carcinoma of the oral cavity.

Development History and FDA Approval Process for Lymphoseek

DateArticle
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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