MONROE TOWNSHIP, N.J., Feb. 2, 2016 /PRNewswire/ -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) approved E-Z-HD for use in double-contrast radiographic examinations of the esophagus, stomach, and duodenum to visualize the gastrointestinal (GI) tract in patients 12 years and older. This is the first regulatory approval of a barium-based contrast agent in the U.S.
"Barium sulfate contrast agents are critically important and routinely used in medical imaging centers nationwide to help diagnose gastrointestinal tract diseases," said Alberto Spinazzi, MD, Senior Vice President, Global Medical and Regulatory Affairs, Bracco Group. "We are proud to be the first company working collaboratively with the FDA to pave a new regulatory path for this class of products. FDA review is critical to ensuring the quality, safety and efficacy of a medicinal product. E-Z-HD is the first in a series of new drug approvals that Bracco is pursuing for its entire line of barium sulfate contrast agents."
The FDA review and approval process requires that pharmaceutical companies demonstrate that their products are safe and effective, and that their manufacturing processes can reliably produce products of expected identity, strength, quality, and purity.
"I commend Bracco's leadership and commitment to healthcare providers who rely on barium sulfate products to help improve patients' health and well-being," said Marc Levine, MD, Professor of Radiology, at the Hospital of the University of Pennsylvania and Advisory Dean, University of Pennsylvania, Philadelphia, PA. "Bracco has set a new bar by ensuring that a safe and effective barium sulfate product meets today's regulatory standards and will continue to be available in the U.S."
Please see Important Safety Information below.
E-Z-HD is indicated for use in double-contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the gastrointestinal (GI) tract in patients 12 years and older.
IMPORTANT SAFETY INFORMATION:
For Oral Administration Only: This product should not be used in patients with known or suspected perforation or obstruction of the GI tract, those with conditions associated to high risk of aspiration or GI perforation, or hypersensitivity to barium sulfate products. Rarely, severe allergic reactions of anaphylactoid nature have been reported following administration of barium sulfate contrast agents.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
E-Z-HD is manufactured for Bracco Diagnostics Inc. by E-Z-EM Canada Inc.
E-Z-HD is a trademark of E-Z-EM, Inc.
For additional information about Bracco's products, and for full prescribing information, please visit http://imaging.bracco.com/us-en. If you have any questions or require additional information about any Bracco product, please contact Bracco Professional Services at 1-800-257-5181, option 2.
About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world's leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.
Bracco Imaging 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. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.
The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.
Operational investments have been made in order to achieve top quality, compliant and sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.
Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and the USA.
To learn more about Bracco Imaging, visit www.braccoimaging.com.
Bracco Diagnostics Inc.
SOURCE Bracco Diagnostics Inc.