FDA to Allow Bracco to Import Iomeron Iodinated Contrast Media as Shortage Drags On
The imaging agent is approved for use in 50 countries in Europe and Asia, but is not currently approved in the US.
In the latest move to further relieve the burden of the ongoing shortage of iodinated contrast media, the US FDA has granted import discretion to Bracco Diagnostics for its nonionic iodinated contrast media agent Iomeron (iomeprol injection) for use in imaging procedures in adults.
As a result of the discretion, the product will be temporarily available in the US starting at the end of August.
"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," said Bracco Diagnostics chief executive officer Jeff Fleming, in a statement.
Iomeron is indicated for use in numerous types of angiography, CT, and urography, including cerebral angiography, thoracic angiography, abdominal angiography, peripheral angiography, intravenous digital subtraction angiography, intraarterial digital subtraction, visualization in computed tomography and intravenous urography.
The agent, which is manufactured in Germany and Italy alongside Bracco's FDA-approved iodinated contrast media agent iopamidol (Isovue), will be availabe in the US in concentrations ranging from 250 mg iodine/mL to 400 mg iodine/mL. Notably, in a letter to health care providers, Bracco points out differences in indications and physico-chemical properties between Iomeron and FDA-approved agents iohexol (Omnipaque), iodixanol (Visipaque), iopromide (Ultravist), ioversol (Optiray), and iopamidol (Isovue).
Earlier this month, the FDA also granted Bayer the ability to import and distribute foreign-labeled iopromide (Ultravist) in the US.
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