Isosulfan blue

Overview

No overview information available.

Indication

Isosulfan Blue is a synthetic visual lymphatic imaging agent. Isosulfan blue upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities.

Associated Conditions

Chylothorax
Chylous Ascites
Chyluria
Secondary and unspecified malignant neoplasm of lymph nodes
Lymph node response to therapeutic modalities
Lymphedema of the extremities

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Axillary Reverse Mapping in Preventing Lymphedema in Patients with Breast Cancer Undergoing Axillary Lymph Node Dissection	2019/04/25	NCT03927027	Phase 3	Active, not recruiting	Alliance for Clinical Trials in Oncology
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery	2013/09/11	NCT01939028	Not Applicable	Terminated	Case Comprehensive Cancer Center
Lymph Node Mapping in Patients With Endometrial Cancer	2013/03/26	NCT01818739	Not Applicable	Completed	Ohio State University Comprehensive Cancer Center
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer	2013/01/18	NCT01771666	Phase 2	Completed	Stanford University
Lymphatic Mapping, Sentinel Lymph Node Analysis, and Blood Tests in Detecting and Predicting Early Micrometastases in Patients With Colorectal Cancer	2008/02/28	NCT00625625	Phase 2	UNKNOWN	Saint John's Cancer Institute
Thoracoscopic Sentinel Lymph Node Biopsy in Patients With Stage I or Stage II Breast Cancer	2007/03/22	NCT00450723	Not Applicable	Completed	University of Miami
Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer	2007/02/22	NCT00438477	Not Applicable	Completed	M.D. Anderson Cancer Center
Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer	2004/05/19	NCT00003186	Not Applicable	Completed	Roswell Park Cancer Institute
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer	2003/10/07	NCT00070317	Not Applicable	Terminated	Gynecologic Oncology Group
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat	2003/01/27	NCT00012168	Not Applicable	Completed	NYU Langone Health

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Isosulfan Blue	AuroMedics Pharma LLC	55150-240	SUBCUTANEOUS	50 mg in 5 mL	12/5/2019
Isosulfan Blue	AnazaoHealth Corporation	51808-206	SUBCUTANEOUS	10 mg in 1 mL	7/9/2012
Isosulfan Blue	Eugia US LLC	55150-240	SUBCUTANEOUS	50 mg in 5 mL	2/15/2024
Isosulfan Blue	Mylan Institutional LLC	67457-220	SUBCUTANEOUS	10 mg in 1 mL	7/19/2017
Isosulfan Blue	Meitheal Pharmaceuticals Inc.	71288-805	SUBCUTANEOUS	10 mg in 1 mL	11/3/2021
LYMPHAZURIN	UNITED STATES SURGICAL CORPORATION	63261-250	SUBCUTANEOUS	10 mg in 1 mL	12/23/2011
Isosulfan Blue	Somerset Therapeutics, LLC	70069-221	SUBCUTANEOUS	10 mg in 1 mL	7/23/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
LYMPHAZURIN 1%	tyco healthcare	00592358	Solution - Subcutaneous	10 MG / ML	12/31/1983

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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