Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR® PUDDING (barium sulfate) oral paste for Fluoroscopy
MONROE TOWNSHIP, N.J., Feb. 27, 2017 /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 VARIBAR PUDDING for modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients six months and older.
Oropharyngeal impairment is a frequent cause of morbidity and disability in all age groups, resulting from congenital abnormalities or a wide spectrum of neurologic causes for impaired swallowing, including cerebrovascular accidents (stroke, the most common cause of swallowing disorders in adults), tumors, motor neuron disease, demyelinating diseases, connective tissue diseases, metabolic disorders, and infections. Accurate and reliable measures of oropharyngeal swallowing function are key to proper patient management and improved outcomes. Radiographic (x-ray) modified barium swallow (MBS) studies are the instrumental examinations of choice because they allow evaluation of both the oral and pharyngeal phases of swallowing, and are key to determine the nature and extent of the swallowing disorder.
«Before the approval of VARIBAR PUDDING, no barium products were approved for use in MBS exams, nor validated prescribing information aiming at guaranteeing optimal and reproducible use and imaging results,» said Alberto Spinazzi, MD, Senior Vice President, Global Medical and Regulatory Affairs, Bracco Group. «Our VARIBAR product line provides an unmet convenience for clinicians and removes the uncertainty that comes with measuring and mixing prior to testing patients. VARIBAR PUDDING’s standard 40% w/v ratio of barium sulfate concentration helps ensure uniform density, eliminating the potential for variability in results. This is our third FDA-approved barium-based contrast agent, which further serves as a testament to Bracco’s commitment to the diagnostic imaging community and the patients they serve.»
VARIBAR PUDDING, formulated with a vanilla flavor for patient compliance, is one of the five viscosity ranges within the VARIBAR product family (VARIBAR® NECTAR (Target Viscosity 300 CPS) BARIUM SULFATE SUSPENSION (40% w/v, 30% w/w), VARIBAR® THIN HONEY (Target Viscosity 1500 CPS) BARIUM SULFATE SUSPENSION (40% w/v, 29% w/w), VARIBAR® THIN LIQUID BARIUM SULFATE SUSPENSION (40% w/v after reconstitution), VARIBAR® HONEY (Target Viscosity 3000 CPS) BARIUM SULFATE SUSPENSION (40% w/v, 29% w/w) and VARIBAR PUDDING). VARIBAR PUDDING is specifically formulated with the minimal coating properties necessary to clearly visualize the dynamic swallowing process. Each VARIBAR viscosity is formulated to provide pleasant, easily tolerated flavors, textures and consistencies, to help elicit a more natural swallowing action in patients who undergo x-ray MBS diagnostic studies to assess oropharyngeal function.
Please see Important Safety Information below.
Indications and Usage:
VARIBAR products are indicated for use in radiography of the esophagus, pharynx and hypopharynx. VARIBAR is indicated for adult use only.
VARIBAR PUDDING is a radiographic contrast agent indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients 6 months of age and older.
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. Aspiration may occur during the modified barium swallow examination, monitor the patient for aspiration.
Please consult full Prescribing Information for VARIBAR PUDDING at http://www.braccoimaging.com/us-en/products-and-solutions/interventional-diagnostic-radiology/varibar/prescribing-information.
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.
VARIBAR is manufactured by E-Z-EM Canada Inc., for E-Z-EM, Inc., a subsidiary of Bracco Diagnostics Inc., Monroe Twp., NJ 08831.
VARIBAR 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.
Bracco Diagnostics Inc.
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SOURCE Bracco Diagnostics Inc.