Lipiodol Transitions from Temporary Importation to Regular Supply
Guerbet Announces Transition from Temporary Importation to Regular Supply for Lipiodol® (ethiodized oil) Injection; also introduces new glass vial container. U.S. manufacturing change from ampoules to vials reflect Guerbet’s commitment to patient safety and innovation in contrast imaging.
PRINCETON, N.J., April 1, 2019 – Guerbet LLC USA, the U.S. affiliate of the global specialist in contrast media products and solutions for diagnostic and interventional imaging, today announced the end of temporary importation status for Lipiodol® (ethiodized oil) Injection and the manufactured availability of the product in the United States. Guerbet has maintained the U.S. product supply of Lipiodol® Ultra Fluid through temporary importation from Delpharm Tours, located in France. The importation remained in effect through February 2019, while Guerbet qualified a new FDA registered manufacturing site.
The newly manufactured Lipiodol® will additionally be packaged in new glass vials, as opposed to glass ampoules. These new Lipiodol® vials eliminate the risk of glass breakage and cracking problems that can be associated with use of glass ampoules.
“Guerbet has spent the last ten years investing in best practices and procedures to ensure the availability of Lipiodol® to all U.S. patients,” said Massimo Carrara, Guerbet Vice President for North America. “The new FDA registered manufacturing site, along with our new packaging, ensures critical availability of the product in a preferred vial format.”
Lipiodol®, is the world’s first oil-based iodinated contrast agent, for both radiologists and patients.
The newly manufactured shipment of Lipiodol® in the new vial container closure system will be delivered to customers during the week of April 1, 2019.
Guerbet is a pioneer in the contrast-agent field, with more than 90 years’ experience, and is a leader in medical imaging worldwide. It offers a comprehensive range of pharmaceutical products, medical devices, and services for diagnostic and interventional imaging to improve the diagnosis and treatment of patients. With 8% of revenue dedicated to R&D and more than 200 employees distributed across its four centers in France, Israel, and the United States, Guerbet is a substantial investor in research and innovation. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €790 million in revenue in 2018. For more information about Guerbet, please visit www.guerbet.com
Please click here for the Lipiodol® Prescribing Information.