FDA Grants Import Discretion of Bracco's Iodinated Contrast Medium Iomeron

By News Release

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

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 US 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).

Jeff Fleming, Chief Executive Officer, Bracco Diagnostics Inc., said, "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. 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."

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FDA Grants Import Discretion of Bracco's Iodinated Contrast Medium Iomeron.  Appl Radiol. 

By News Release| July 28, 2022

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