The U.S. Food and Drug Administration (FDA) will now allow Bayer to import a limited quantity of iopromide (Ultravist), initially intended for international markets, for U.S. customers.
Bayer said it asked the FDA to allow this in response to iodinated contrast media shortages caused by supply pressures resulting from COVID-19 lockdowns in China. The imported stock is manufactured at the same site that manufactures the iopromide in Berlin.
The iopromide injection is approved only for intra-arterial and intravenous administration and not for intrathecal use. The company is directing people to the U.S. Prescribing Information page for more information.