Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, 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.
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.
