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FDA grants import discretion of Bracco's iodinated contrast medium Iomeron (iomeprol injection) to address supply shortages

Press releases may be edited for formatting or style | July 27, 2022 CT MRI X-Ray
MILAN, July 27, 2022 /PRNewswire/ -- Bracco Diagnostics Inc., a U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced that the U.S. Food and Drug Administration (FDA) granted import discretion of Iomeron® (iomeprol injection) into the U.S. to address the ongoing iodinated contrast media shortage.

Iomeron® (iomeprol injection) is a nonionic iodinated contrast medium for intravascular use in adults in various imaging procedures. Currently registered in over 50 countries in Europe and Asia, it is not approved for use in the United States.

The product addresses the need for the most advanced diagnostic imaging standards and will be temporarily available in the U.S. market starting at the end of August 2022. It is manufactured at two Bracco locations: BIPSO GmbH, Singen (Germany), and Patheon Italia S.p.A., Ferentino (Italy).

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Jeff Fleming, Chief Executive Officer, Bracco Diagnostics Inc., said, "Throughout its 95-year history, Bracco has always put people and innovation at the core of its business, and focused ongoing attention on patient health, safety, and quality of care. 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."

About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology dedicated to advancing next generation targeted radiotherapeutics to treat patients who have cancer.

SOURCE Bracco Diagnostics Inc.

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