Bracco Diagnostics, Inc., announced today FDA approval of its READI-CAT 2 and READI-CAT 2 smoothie for use in contrast-enhanced CT examinations.
The approval marks the second-ever FDA approval for a barium-based contrast agent, following on the heels of Bracco’s recently approved E-Z-HD oral suspension, and the first such approval for a barium-based agent designed for CT imaging, the company said in a press release.
"Bracco's regulatory program is aimed at advancing barium imaging products through the FDA's evidence-based system of drug approval that guarantees new drugs meet all necessary standards for safety, effectiveness, quality, and labeling," said Bracco Senior Vice President, Global Medical and Regulatory Affairs, Alberto Spinazzi, MD. “The approval of READI-CAT 2 and READI-CAT 2 Smoothies, following that of E-Z-HD (barium sulfate) for oral suspension, shows Bracco's commitment to keeping cost effective and safe imaging solutions available to healthcare professionals."
The recently approved agents are designated for use in contrast-enhanced abdominal CT to help image the gastrointestinal tracts of adult and pediatric patients.