News | February 20, 2014

Guerbet Receives FDA Approval for Lipiodol Contrast Agent Manufacturing Plant

Guerbet Lipiodol Contrast Agent Media FDA Approval

February 20, 2014 — Guerbet, a contrast agent specialist for medical imaging, received U.S. Food and Drug Administration (FDA) approval for a manufacturing plant for Lipiodol (ethiodized oil) Injection, in Montreal, Canada.

Lipiodol is indicated for use as a radio-opaque medium for lymphography and hysterosalpingography. It contains 475 mg Iodine/mL organically combined with ethyl esters of the fatty acids (primarily as ethyl monoiodostearate and ethyl diiodostearate) of poppyseed oil. Lipiodol is supplied in a box of one 10 mL ampoule.

FDA approval provides clinicians with additional resource for patient care management.

Guerbet has acquired the Ethiodol NDA effective May 7, 2010 and since then has been working with the FDA to resume manufacturing of Ethiodol to ensure continued availability to U.S. patients. During this interim period, Guerbet, in conjunction with the FDA, maintained a temporary importation of Lipiodol. Lipiodol contains the same drug components as Ethiodol.

Guerbet plans to transition from the temporary importation program as soon as product from the newly approved manufacturing plant is available in the United States.

For more information: guerbet.com

Related Content

Imaging agent helps predict success of lung cancer therapy
News | Oncology Diagnostics | March 08, 2018
March 8, 2018 – Doctors contemplating the best therapy for...
OptiStar Elite injector
Feature | Contrast Media Injectors | March 07, 2018 | Grand View Research Inc.
The global contrast media injectors market is expected to reach $1.4 billion by 2025, growing at a compound annual...
TriHealth in Cincinnati

TriHealth in Cincinnati.

Sponsored Content | Case Study | Contrast Media Injectors | March 06, 2018
The continuing search for advantages to improve workflow has radiology departments constantly searching for new...
Guerbet Presents Contrast&Care Injection Management Solution at ECR 2018
News | Contrast Media | February 28, 2018
February 28, 2018 — Guerbet will present its new Contrast&Care application, as well as other...
A brain MRI. Gadolinium contrast agents (GBCAs) are partly retained in the brain, raising safety concerns. Gadolinium deposition in the brain has raised concerns about Gadolinium toxicity.

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

Feature | Magnetic Resonance Imaging (MRI) | February 16, 2018 | Dave Fornell
One of the biggest concerns in radiology in recent years is the safety of gadolinium-based contrast agents (GBCAs) us
ACR Introduces New Contrast Reaction Card
News | Contrast Media | February 07, 2018
The American College of Radiology (ACR) introduced a new contrast reaction card that summarizes important steps to be...
Bracco Diagnostics' MultiHance Contrast Agent Earns Expanded Approval for Pediatric MRI
News | Contrast Media | January 30, 2018
Bracco Diagnostics Inc. announced the labeling of its contrast agent MultiHance has obtained U.S. Food and Drug...
Study Finds No Evidence that Gadolinium Causes Neurologic Harm

MR images through, A, C, E, basal ganglia and, B, D, F, posterior fossa at level of dentate nucleus. Images are shown for, A, B, control group patient 4, and the, C, D, first and, E, F, last examinations performed in contrast group patient 13. Regions of interest used in quantification of signal intensity are shown as dashed lines for globus pallidus (green), thalamus (blue), dentate nucleus (yellow), and pons (red).

News | Contrast Media | January 11, 2018
January 11, 2018 — There is no evidence that accumulation in the brain of the element gadolinium speeds cognitive dec
Male Triathletes May Be Putting Their Heart Health at Risk
News | Cardiac Imaging | January 09, 2018
Competitive male triathletes face a higher risk of a potentially harmful heart condition called myocardial fibrosis,...
Overlay Init