FDA gives nod to Bracco to import Iomeron to U.S.

In a move to alleviate the ongoing shortage of iodinated contrast media, the U.S. Food and Drug Administration (FDA) has allowed Bracco Diagnostics to import its Iomeron (iomeprol) contrast agent into the U.S.

Iomeron is sold in 50 countries worldwide but does not have approval to be sold in the U.S. The agent is indicated for intravascular use in adults with various imaging procedures.

Iomeron is manufactured at facilities in Germany and Italy; it will be available in the U.S. on a temporary basis starting at the end of August 2022, according to Bracco Diagnostics, a subsidiary of Bracco Imaging in Italy.

Medical imaging facilities have been coping with a shortage of contrast media in the U.S. since a factory in Shanghai, China, that makes contrast for GE Healthcare was shut down earlier this year due to COVID-19 lockdown rules. While the factory is returning to full production, contrast shortages continue to ripple throughout U.S. radiology.