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.

About E-Z-HD
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.

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