FDA Approves Breakthrough Barium-Based Product for Contrast Radiography

The US Food and Drug Administration (FDA) has approved a Barium Sulfate oral contrast agent for double-contrast radiographic exams of the esophagus, stomach, and duodenum, for patients who are 12 years and older.

The agent, which is used to visualize the gastrointestinal tract, is the first barium-based contrast agent to received regulatory approval in the US. The FDA approval indicates that the agent is safe and effective, that the manufacturing processes is reliable, and that the agent can be sold in the US.

The E-Z-HD agent was developed by Bracco Imaging (Monroe Township, NJ, USA), part of the Bracco Group (Milan, Italy). Bracco is a leading global diagnostic imaging business company that develops, manufactures, and markets diagnostic imaging agents and other medical solutions.

Alberto Spinazzi, MD, senior vice president, Global Medical and Regulatory Affairs, of the Bracco Group, said, "Barium sulfate contrast agents are critically important and routinely used in medical imaging centers nationwide to help diagnose gastrointestinal tract diseases. 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."

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