To address the ongoing COVID-19-related shortage of iodinated contrast media, the Food and Drug Administration (FDA) has allowed for temporary importation of Bracco Diagnostics’ Iomeron® (iomeprol injection) into the United States.
Iomeron is a nonionic iodinated contrast medium for intravascular use in adults for various imaging procedures. The product is manufactured by BIPSO GmbH in Germany and Patheon Italia S.p.A in Italy, but is not FDA approved for use in the US. These facilities are also used to manufacture Bracco Diagnostics’ FDA-approved intravascular iodinated contrast medium, Isovue® (iopamidol injection).
Iomeron will be available in the US starting at the end of August 2022. Product details, including presentations, physico-chemical properties, and approved uses, can be found here.
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Reference
FDA grants import discretion of Bracco’s iodinated contrast medium Iomeron® (iomeprol injection) to address supply shortages. News release. Bracco Diagnostics Inc. Accessed July 27, 2022. https://www.prnewswire.com/news-releases/fda-grants-import-discretion-of-braccos-iodinated-contrast-medium-iomeron-iomeprol-injection-to-address-supply-shortages-301593791.html
This article originally appeared on MPR
