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Biopharmaceuticals Radiology FDA

 News Release - September 25, 2017

Bracco Diagnostics Inc. Receives U.S. FDA Approval for TAGITOL(TM) V (Barium Sulfate) Oral Suspension

First Imaging Agent Approved for use During Computed Tomographic (CT) Colonography (CTC) procedures

MONROE TOWNSHIP, N.J., Sept. 25, 2017 -- (Healthcare Sales & Marketing Network) -- Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration (FDA) approved TAGITOL V (barium sulfate) oral suspension for use in adult patients undergoing a CTC.

TAGITOL™ V (barium sulfate) oral suspension is a low-volume fecal tagging agent used to opacify residual stool in the colon for CT imaging. It blends into the stool as it forms, resulting in immediate, visible identification of retained feces.

CTC (virtual colonoscopy) is a diagnostics imaging test that provides a computer-simulated endoluminal perspective of the colon, and is a validated screening test for colorectal cancer (CRC). In 2016, the United States Preventive Service Task Force included CTC in its recommendation of screening tests for CRC, placing it in the same rating category as optical colonoscopy, which has been considered the "gold standard" for CRC screening.1

CTC and optical colonoscopy screening tests allow direct visualization of colon abnormalities that are or may become cancerous.2 Tagging residual material with radiopaque contrast during a CTC offers the benefit of differentiating true polyps versus stool, and helps decrease the number of false positives.3 The TAGITOL V fecal tagging agent is the first contrast imaging agent approved by the FDA to meet this important medical need.

"Colorectal cancer is one of the leading causes of cancer death in the United States; however, the survival rate is about 90% when detected at an early stage," said Alberto Spinazzi, MD, Senior Vice President, Global Medical and Regulatory Affairs, Bracco Group. "Unfortunately, only a fraction of the people who should be getting screened for colon cancer, are getting the tests that they should. CTC is a validated test that could boost screening rates because it is fast, noninvasive and does not require sedation. The use of TAGITOL V contrast can improve the diagnostic accuracy of this important test."

Bracco Diagnostics Vice President of Marketing James Moran said, "Bracco has been a leading proponent of the development of CTC and developed TAGITOL V contrast to help physicians make an accurate diagnosis. Continuing its leadership role, Bracco developed and sponsors https://www.myctcolonography.com/, a website designed to educate patients and their primary care physicians about CTC, which provides patients with a resource to locate facilities that offer CTC testing. Bracco remains committed to offer products that meet critical diagnostic needs and to provide education to both healthcare professionals and patients."

Please see Important Safety Information below.

Indications and Usage:

TAGITOL V (barium sulfate) oral suspension is indicated for use in adult patients for use in computed tomography (CT) colonography as a fecal tagging agent.

IMPORTANT SAFETY INFORMATION:

For Oral Administration. This product is contraindicated in patients with known or suspected perforation of the gastrointestinal (GI) tract, known obstruction of the GI tract, or hypersensitivity to barium sulfate products. Rarely, severe allergic reactions of anaphylactoid nature have been reported following administration of barium sulfate contrast agents.

Please see full Prescribing Information for TAGITOL V contrast at: www.braccoimaging.com/us-en/products/ct-ct-colonography/tagitol-v

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.

TAGITOL V is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 08831.

TAGITOL is a 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.

1 United States Preventive Service Task Force. Screening for Colorectal Cancer United States Preventive Service Task Force. Recommendation Statement. JAMA. 2016 315(23): 2564 – 2575.

2 El Zoghbi M, Cummings LC. New era of colorectal cancer screening. World Journal of Gastrointestinal Endoscopy. 2016; 8(5): 252 – 258.

3 Yee J, Weinstein S, Morgan T, et al. Advances in CT Colonography for Colorectal Cancer Screening and Diagnosis. Journal of Cancer. 2013; 4(3): 200 – 209.


Source: Bracco Diagnostics

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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