Bracco Diagnostics Inc. Receives Second U.S. FDA Approval for Barium-Based Products, The First in Computed Tomography

Feb 22, 2016, 08:50 ET from Bracco Diagnostics Inc.

MONROE TOWNSHIP, N.J., Feb. 22, 2016 /PRNewswire/-- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced the U.S. Food and Drug Administration (FDA) 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 adult and pediatric patients. This is the second regulatory approval of a barium-based contrast agent in the U.S., and the first for use in modern CT imaging making Bracco the only company with FDA-approved barium based contrast agents.

"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 Alberto Spinazzi, MD, Senior Vice President, Global Medical and Regulatory Affairs, Bracco Group. "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."

READI-CAT 2 is supplied in 450mL bottles. READI-CAT 2 SMOOTHIES are available for use by adult and pediatric patients in Berry, Banana, Creamy Vanilla and Mochaccino flavors, also in 450mL bottles.

"In my experience, the READI-CAT 2 and READI-CAT 2 SMOOTHIES are beneficial to patients and radiology teams alike, as they come ready to serve, in multiple flavors that help streamline the imaging process and make them more palatable for patients." said Judy Yee, MD, FACR, Professor and Vice Chair Radiology and Biomedical Imaging at UCSF, and Chief of Radiology at the San Francisco VA Medical Center. "I commend Bracco for their efforts to improve the overall imaging experience for patients."

Please see Important Safety Information below.

About READI-CAT 2 and READI-CAT 2 SMOOTHIE
READI-CAT 2 AND READI-CAT 2 SMOOTHIE are indicated for use in computed tomography (CT) of the abdomen to delineate the gastrointestinal (GI) tract in adult and pediatric patients.

READI-CAT 2 and READI-CAT 2 SMOOTHIE Important Safety Information:
For Oral Administration Only: This product should not be used in patients with known or suspected perforation or obstruction of the GI tract, those with conditions associated to high risk of aspiration or GI perforation, or hypersensitivity to barium sulfate products. Rarely, severe allergic reactions of anaphylactoid nature have been reported following administration of barium sulfate contrast agents.

About E-Z-HD
E-Z-HD is indicated 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.

E-Z-HD Important Safety Information:
For Oral Administration Only: This product should not be used in patients with known or suspected perforation or obstruction of the GI tract, those with conditions associated to high risk of aspiration or GI perforation, or hypersensitivity to barium sulfate products. Rarely, severe allergic reactions of anaphylactoid nature have been reported following administration of barium sulfate contrast agents. 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional information about Bracco's products, and for full prescribing information, please visit http://imaging.bracco.com/us-en. If you have any questions or require additional information about any Bracco product, please contact Bracco Professional Services at 1-800-257-5181, option 2. 

READI-CAT and E-Z-HD are manufactured for Bracco Diagnostics Inc., Monroe Township, NJ 08831 by E-Z-EM Canada Inc.

E-Z-HD is a trademark of E-Z-EM, Inc.

READI-CAT is a registered trademark of E-Z-EM, Inc.

About Bracco Imaging
Bracco Imaging S.p.A., part of the Bracco Group, is one of the world's leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.

Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers. The diagnostic imaging portfolio is completed by a range of medical devices and advanced administration systems for contrast imaging products.

The Company operates in over 100 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America, Europe and Japan operating through the Joint Venture Bracco-Eisai Co. Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.

Operational investments have been made in order to achieve top quality, compliant and sustainable
eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China, and Germany.

Bracco Imaging is an innovative Research and Development (R&D) structure with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centers located in Italy, Switzerland, and the USA.

To learn more about Bracco Imaging, visit www.braccoimaging.com.

Press Contact:  
Kimberly Gerweck
Bracco Diagnostics Inc.
Kimberly.Gerweck@diag.bracco.com 

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SOURCE Bracco Diagnostics Inc.



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