tilmanocept
tilmanocept is listed in the FDA National Drug Code directory with 2 NDC codes, marketed under brand name including Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept). Available dosage form: kit.
Drug Details
- Generic Name
- tilmanocept
- Brand Names
- Kit for the preparation of Lymphoseek (technetium Tc 99m tilmanocept)
- Application Number
- NDA202207
- Sponsor
- Cardinal Health 414, LLC
- NDC Codes
- 2
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 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. 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. ( 1 ) • 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. ( 1 )