FDA Gives Okay for Bracco to Import Contrast Medium

This follows a move by Bayer to import Ultravist with non-U.S. labeling also to address pandemic-related shortages of iodine-containing contrast media used in imaging procedures.

The FDA has allowed Bracco Diagnostics to import Iomeron (iomeprol injection) into the United States to address the ongoing iodinated contrast media shortage. Iodinated contrast media are contrast agents that contain iodine atoms used for x-ray-based imaging such as computed tomography (CT).

Iomeron is an iodinated contrast medium for intravascular use in adults in various imaging procedures. It is currently registered in more than 50 countries in Europe and Asia, but it is not approved for use in the United States. Iomeron will be temporarily available in the United States at the end of August 2022. It is manufactured at two Bracco locations: BIPSO in Germany and Patheon in Italy.

The FDA is allowing this importation to address shortages of GE Healthcare’s Omnipaque (iohexol injection) and Visipaque (iodixanol injection), as well as Bayer’s Ultravist (iopromide injection).

GE Healthcare, in particular, has experienced challenges related to manufacturing Omnipaque and Visipaque because of the COVID-19 pandemic. The company’s plant is located in Shanghai, which has experienced closures related to China’s COVID-19 policies. This has created supply disruption. In a statement issued July 15, 2022, the company said the Shanghai facility is operating at full capacity but indicated that there will continue to be reduced availability of its iodinated contrast media.

The supply of Bayer’s Ultravist has also experienced disruption because of the pandemic. In June 2022, the company announced it had received approval from the FDA to import Ultravist with non-U.S. labeling. The product to be imported is manufactured at the same site in Germany as the U.S.-label Ultravist, but doesn’t include FDA approved labeling and the package inserts may differ. The bar codes are also different, the company indicated.