Technology | April 18, 2014

FDA Approves Lipiodol (Ethiodized Oil) to Image Tumors in Adults With Known Hepatocellular Carcinoma

FDA Approves Lipiodol (Ethiodized Oil) to Image Tumors in Adults With Known Hepatocellular Carcinoma

April 18, 2014 — Guerbet announced that Lipiodol was approved by the U.S. Food and Drug Administration (FDA), indicated for selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC). HCC is the most common primary liver tumor and represents the third-leading cause of cancer-related death in the world, with prevalence in the United States estimated to affect in the range of 35,000 patients in 2013. As previously announced in October 2013, Lipiodol has received an orphan-drug designation for management of patients with known HCC.

"Guerbet is pleased to have been granted approval for use of Lipiodol in patients with known HCC. This product has been supplied during the past three years under a temporary importation program. Guerbet's efforts to improve the availability of Lipiodol in the U.S. are in line with our company mission of offering reliable and innovative solutions to improve the efficacy of interventional radiology procedures," said Massimo Carrara, Guerbet U.S. general manager.

This approval was received shortly after FDA granted approval to a new site to manufacture Lipiodol, validated for U.S. distribution only (Jubilant HollisterStier, Canada). Guerbet plans to transition from the temporary importation program as soon as product from the newly approved manufacturing plant will be available in the U.S.

Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding. It is indicated for hysterosalpingography in adults, lymphography in adults and children, and selective hepatic intra-arterial use for imaging tumors in adults with known HCC.

For more information: www.guerbet.com

Related Content

Videos | Radiation Oncology | November 06, 2018
Genomics can be used to assess a patient's radiosensitivity, which can be used to increase or decrease the radiation
Osprey Medical and GE Healthcare Launch Acute Kidney Injury Educational Program
News | Angiography | September 25, 2018
September 21, 2018 — Osprey Medical announced a collaboration with GE Healthcare on Osprey’s Be Kind to Kidneys campa
News | Radiation Dose Management | September 24, 2018
AngioDynamics Inc. announced an agreement to acquire RadiaDyne, a privately held medical diagnostic and device company...
Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns, as seen in this MRI.

News | Contrast Media | September 12, 2018
In February 2018, a workshop was held at the National Institutes of Health (NIH) in Bethesda, Maryland, to explore co
Scientists Develop New MRI Tool for Cancer Diagnosis and Therapy

Researchers in the laboratory ‘Biomedical Nanomaterials’ of NUST MISIS. Image courtesy of PR Newsfoto/NUST MISIS.

News | Oncology Diagnostics | August 24, 2018
A European research group has developed a system that allows doctors to both improve the accuracy of diagnosing...
Iron Outperforms Gadolinium as MRI Contrast Agent

Scientists at Rice's Laboratory for Nanophotonics added iron chelates (blue) and fluorescent dye (red) to multi-layered gold nanomatryoshkas to create particles that can be used for disease therapy and diagnostics. The "theranostic" nanoparticles have a core of gold (left) that is covered by silica containing the diagnostic iron and dye, which is covered by an outer shell of gold. The particles are about 20 times smaller than a red blood cell, and by varying the thickness of the layers, LANP scientists can tune the nanomatryoshkas to convert light into cancer-killing heat. (Image courtesy of Luke Henderson/Rice University)

News | Contrast Media | August 22, 2018
Rice University nanoscientists have demonstrated a method for loading iron inside nanoparticles to create magnetic...
Guerbet Partners With Imalogix on Dose Optimization With Artificial Intelligence
News | Radiation Dose Management | August 14, 2018
August 14, 2018 — Guerbet LLC USA announced a commercial partnership with Imalogix, a provider of...
Videos | Contrast Media | August 03, 2018
Lawrence Tanenbaum, M.D., FACR, vice president and director of advanced imaging at RadNet, discusses the latest resea
Guerbet, IBM Watson Health Partner on Artificial Intelligence for Liver Imaging
News | Clinical Decision Support | July 10, 2018
Guerbet announced it has signed an exclusive joint development agreement with IBM Watson Health to develop an...
Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...