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The Food and Drug Administration (FDA) has given the green light to Bayer to import foreign-labeled iopromide (Ultravist) to help alleviate ongoing supply challenges with iodinated contrast media in the United States.
In light of continued supply issues with iodinated contrast media stemming from a temporary COVID-19-related shutdown of a GE Healthcare manufacturing plant in Shanghai earlier this year, the Food and Drug Adminstration (FDA) is allowing Bayer to import and distribute foreign-labeled iopromide (Ultravist) in the United States.
Bayer emphasized that Ultravist is indicated for intra-arterial and intravenous administration. The modality is contraindicated for intrathecal administration, according to Bayer.
The company added that clinicians should be aware of differences between the package inserts for the foreign-labeled iopromide and the U.S. version, and defer to the U.S. prescribing information for iopromide.
For additional questions about the use of iopromide, one may contact Bayer Healthcare Pharmaceuticals at (888) 842-2937.
(Editor’s note: For related content, see “Iodinated Contrast Media Shortage: Practical Solutions and Applications in Radiology,” “Lessons Learned from the Iodinated Contrast Media Shortage: A Neuroradiologist’s Perspective,” “Emerging Strategies for Managing the Acute Shortage of Iodinated Contrast Media” and “Iodinated Contrast Media: 15 Recommendations for Addressing the Shortage.”)