News | Contrast Media | August 02, 2022

Bracco Diagnostics Inc. has announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage. The product addresses the need for the most advanced diagnostic imaging standards and will be temporarily available in the U.S. market starting at the end of August, 2022.

Bracco Diagnostics has announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron® (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage.

Photo credit: Getty Images


August 2, 2022 – A new update has been announced as the radiology world continues to address supply disruptions of contrast media.

Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A. has announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage, according to a news release issued by the company July 27, from its headquarters in Milan, Italy.

Iomeron (iomeprol injection) is a nonionic iodinated contrast medium for intravascular use in adults in various imaging procedures. Currently registered in over 50 countries in Europe and Asia, it is not approved for use in the United States.

The product addresses the need for the most advanced diagnostic imaging standards and will be temporarily available in the U.S. market starting at the end of August, 2022. It is manufactured at two Bracco locations: BIPSO GmbH, Singen (Germany), and Patheon Italia S.p.A., Ferentino (Italy).

The company offered detailed information on the temporary importation, including Importation Discretion Documentation and a Letter to Healthcare Professionals.

“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 Jeff Fleming, Chief Executive Officer, Bracco Diagnostics Inc. “Throughout its 95-year history, Bracco has always put people and innovation at the core of its business, and focused ongoing attention on patient health, safety, and quality of care,” added Fleming.

The temporary importation being allowed by the FDA addresses shortages of GE Healthcare’s Omnipaque (iohexol injection) and Visipaque (iodixanol injection), and Bayer’s Ultravist (iopromide injection) which resulted from COVID-19 related supply disruptions. 

Related coverage on the contrast media shortage can be found here:

https://www.itnonline.com/content/global-contrast-media-shortage-strate…

https://www.itnonline.com/content/global-contrast-media-shortage-means-…


Related Content

News | Clinical Trials

March 30, 2023 —According to an accepted manuscript published in ARRS’ own American Journal of Roentgenology (AJR) ...

Time March 30, 2023
arrow
News | PET Imaging

March 23, 2023 — Nuclidium announced that the Neuroendocrine Tumors Research Foundation (NETRF) has selected the company ...

Time March 24, 2023
arrow
News | Artificial Intelligence

March 17, 2023 — A new paper published in the Journal of Medical Internet Research describes how generative models such ...

Time March 17, 2023
arrow
News | Artificial Intelligence

March 10, 2023 — Computed tomography (CT) is one of the most powerful and well-established diagnostic tools available to ...

Time March 10, 2023
arrow
News | Contrast Media

March 2, 2023 — GE HealthCare announced at the European Congress of Radiology (ECR) in Vienna, Austria, the completion ...

Time March 02, 2023
arrow
News | SPECT-CT

March 2, 2023 —Royal Philips announced new milestones in the development of the world’s first spectral detector angio CT ...

Time March 02, 2023
arrow
News | X-Ray

March 2, 2023 — Carestream Health is funding and participating in an innovative pilot with the Open Source Imaging ...

Time March 02, 2023
arrow
News | Radiation Oncology

March 2, 2023 — Ascelia Pharma, a biotech company focused on improving the life of people living with rare cancer ...

Time March 02, 2023
arrow
News | Computed Tomography (CT)

March 1, 2023 — According to an accepted manuscript published in ARRS’ American Journal of Roentgenology (AJR), using a ...

Time March 01, 2023
arrow
Videos | Contrast Media

Bracco Diagnostics and Guerbet recently announced they had formed a strategic, global collaboration for the research ...

Time February 27, 2023
arrow
Subscribe Now