FDA Nod for Bracco’s Barium-Sulfate Oral Suspension

February 23, 2016

FDA approves Bracco’s READI-CAT 2 and READI-CAT 2 SMOOTHIE for use in abdominal CT.

The U.S. Food and Drug Administration has approved a New Drug Application for READI-CAT 2 and READI-CAT 2 SMOOTHIE, barium sulfate oral suspensions for use in CT.

READI-CAT 2 and READI-CAT 2 SMOOTHIE, products of Bracco Imaging, a subsidiary of Bracco Diagnostics, are used in CT of the abdomen to delineate the gastrointestinal tract in adult and pediatric patients, a release said.

This approval is the second regulatory approval of a barium-based contrast agent in the U.S., and the first for use in modern CT imaging, Bracco’s release said.

READI-CAT 2 is supplied in 450 mL bottles; READI-CAT 2 SMOOTHIES, also in 450 mL bottles, are available for use by adult and pediatric patients in berry, banana, creamy vanilla and mochaccino flavors.