News | Contrast Media | August 02, 2022

FDA Grants Import Discretion of Bracco’s Iodinated Contrast Medium Iomeron (iomeprol injection) to Address Supply Shortages

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.

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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-…