FDA to Allow Bracco to Import Iomeron Iodinated Contrast Media as Shortage Drags On

Article

The imaging agent is approved for use in 50 countries in Europe and Asia, but is not currently approved in the US.

In the latest move to further relieve the burden of the ongoing shortage of iodinated contrast media, the US FDA has granted import discretion to Bracco Diagnostics for its nonionic iodinated contrast media agent Iomeron (iomeprol injection) for use in imaging procedures in adults.

As a result of the discretion, the product will be temporarily available in the US starting at the end of August.

"We are proud that the company has worked proactively with the FDA to address the shortage of iodinated contrast agents in the U.S. market," said Bracco Diagnostics chief executive officer Jeff Fleming, in a statement.

Iomeron is indicated for use in numerous types of angiography, CT, and urography, including cerebral angiography, thoracic angiography, abdominal angiography, peripheral angiography, intravenous digital subtraction angiography, intraarterial digital subtraction, visualization in computed tomography and intravenous urography.

The agent, which is manufactured in Germany and Italy alongside Bracco's FDA-approved iodinated contrast media agent iopamidol (Isovue), will be availabe in the US in concentrations ranging from 250 mg iodine/mL to 400 mg iodine/mL. Notably, in a letter to health care providers, Bracco points out differences in indications and physico-chemical properties between Iomeron and FDA-approved agents iohexol (Omnipaque), iodixanol (Visipaque), iopromide (Ultravist), ioversol (Optiray), and iopamidol (Isovue).

Earlier this month, the FDA also granted Bayer the ability to import and distribute foreign-labeled iopromide (Ultravist) in the US.


Recent Videos
Study: MRI-Based AI Enhances Detection of Seminal Vesicle Invasion in Prostate Cancer
Can AI Assessment of Longitudinal MRI Scans Improve Prediction for Pediatric Glioma Recurrence?
A Closer Look at MRI-Guided Adaptive Radiotherapy for Monitoring and Treating Glioblastomas
Incorporating CT Colonography into Radiology Practice
What New Research Reveals About Computed Tomography and Radiation-Induced Cancer Risk
Can Deep Learning Provide a CT-Less Alternative for Attenuation Compensation with SPECT MPI?
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
Related Content
© 2025 MJH Life Sciences

All rights reserved.