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LYMPHAZURIN

NDA

ISOSULFAN BLUE | N018310 | COVIDIEN

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Lachman Consulting Services, Inc FDA-2023-P-4328 · 8 docket documents Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to file an ANDA for Isosulfan Blue Injection, 1%, 3 mL prefilled syringe, a new strength product based on the reference listed drug LYMPHAZURIN (Isosulfan Blue), 1%, 5	Suitability	2023-10-05	Granted	Lachman Consulting Services, Inc
Suitability Petition from Lachman Consulting Services, Inc. FDA-2023-P-4297 · 8 docket documents Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client pursuant to Section 505(j)(2)(C) of the FD&C Act requesting FDA approval to declare Isosulfan Blue Injection, 1%, 1 mL prefilled syringe suitable for ANDA submission based on the listed reference drug LYMPHAZURIN	Suitability	2023-10-03	Granted	Lachman Consulting Services, Inc.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

17 trials from ClinicalTrials.gov, 1 active, 11 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Axillary Reverse Mapping in Preventing Lymphedema in Patients With Breast Cancer Undergoing Axillary Lymph Node Dissection NCT03927027	Phase 3	Active	Alliance for Clinical Trials in Oncology	534	2019-07-29 → 2027-01
Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma NCT01898403	N/A	Completed	Stanford University	50	2013-06 → 2015-04
Lymphoscintigraphy to Detect Early Metastases in Patients With Cancer of the Mouth or Throat NCT00012168	N/A	Completed	NYU Langone Health	—	1999-05
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG NCT02068820	N/A	Completed	AdventHealth	200	2012-09 → 2015-01
A Study of Lymphoseek® as a Lymphoid Tissue Targeting Agent in Pediatric Patients With Melanoma, Rhabdomyosarcoma, or Other Solid Tumors Who Are Undergoing Lymph Node Mapping NCT02509598	Phase 2	Completed	Cardinal Health 414, LLC	24	2015-08 → 2019-03-06
SentiMag® Intraoperative Comparison in Breast Cancer NCT02336737	N/A	Completed	Endomagnetics Inc	160	2015-01 → 2015-12
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer NCT01771666	Phase 2	Completed	Stanford University	23	2012-07 → 2015-03-17
Injection Methods in Finding the Sentinel Lymph Node During Lymphatic Mapping and Sentinel Lymph Node Biopsy in Patients With Invasive Breast Cancer NCT00438477	N/A	Completed	M.D. Anderson Cancer Center	74	2005-06 → 2008-04
Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer NCT00003186	N/A	Completed	Roswell Park Cancer Institute	—	1997-04
Lymph Node Mapping in Patients With Endometrial Cancer NCT01818739	N/A	Completed	Ohio State University Comprehensive Cancer Center	204	2013-03 → 2017-03-31

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain8 active DMFs1 inactive

8 active API suppliers hold Drug Master Files for this ingredient.

MYLAN PHARMACEUTICALS INC A VIATRIS COISOSULFAN BLUE

DMF 218832008

APITORIA PHARMA PRIVATE LTDISOSULFAN BLUE

DMF 277952013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDISOSULFAN BLUE

DMF 298292015

DISHMAN CARBOGEN AMCIS LTDISOSULFAN BLUE

DMF 312262016

EMCURE PHARMACEUTICALS LTDISOSULFAN BLUE

DMF 331992018

MSN LABORATORIES PRIVATE LTDISOSULFAN BLUE

DMF 347172020

AGNO PHARMAISOSULFAN BLUE

DMF 349752020

SUVEN PHARMACEUTICALS LTDISOSULFAN BLUE

DMF 372582022

SAFC PHARMAInactiveISOSULFAN BLUE

DMF 208912007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 8, 2007	SUPPL -11	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;SUBCUTANEOUS | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.