Lymphoseek Kit

Used in scans for solid tumors. NDA 202207, held by Cardinal Health 414. Technetium Tc-99m Tilmanocept.

As of Nov 13, 2026, NDA 202207 (Lymphoseek Kit), held by Cardinal Health 414, was first approved by FDA on Mar 13, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 13, 2013
Review: Standard
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Lymphoseek 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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below


May 19, 2021	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 14, 2014	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 13, 2014	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 13, 2013	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lymphoseek KitN/A · injectable;injection	Technetium Tc-99m Tilmanocept	RxReference drug

All 8 submissions, including labeling and manufacturing supplements


May 19, 2021	Supplement 12Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 8, 2019	Supplement 9Labeling · Standard review	Approved	Label Letter
Nov 30, 2016	Supplement 6Manufacturing · Standard review	Approved	None posted
Oct 20, 2016	Supplement 5Manufacturing	Approved	Label
Aug 3, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 14, 2014	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 13, 2014	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 13, 2013	Original applicationNew molecular entity · Standard review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 202207
Drugs@FDA: Overview at FDA
Company: Cardinal Health 414

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters