Bracco Diagnostics announced that the Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for READI-CAT 2 and READI-CAT 2 SMOOTHIE (barium sulfate) oral suspension for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in pediatric and adult patients.
The approval of READI-CAT 2 and READI-CAT 2 SMOOTHIE marks the second regulatory approval of a barium-based contrast agent in the United States. This follows the FDA approval of E-Z-HD for oral suspension in February 2016 indicated for double-contrast radiographic examinations of the esophagus, stomach, and duodenum to visualize the GI tract in patients ≥12 years.
Barium sulfate, due to its high molecular density is opaque to x-rays and, acts as a positive contrast agent for radiographic studies. It is biologically inert and, therefore, is not absorbed or metabolized by the body, and is eliminated from the GI tract unchanged.
Both READI-CAT and READI-CAT 2 SMOOTHIES are available in 450mL bottles. READI-CAT 2 SMOOTHIES for pediatric and adult patients are available as berry, banana, creamy vanilla and mochaccino flavors.
For more information call (877) 272-2269 or visit BraccoImaging.com.