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 Food and Drug FDA approval for VARIBAR® THIN LIQUID (barium sulfate) for oral suspension which is indicated for modified barium swallow (MBS) studies used to detect and assess the type and severity of swallowing disorders also known as dysphagia.
| MONROE TOWNSHIP, N.J., Aug. 5, 2019 /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 Food and Drug FDA approval for VARIBAR® THIN LIQUID (barium sulfate) for oral suspension which is indicated for modified barium swallow (MBS) studies used to detect and assess the type and severity of swallowing disorders also known as dysphagia.
In the U.S., approximately 13 million (1 in 25) Americans suffer from dysphagia.1 Dysphagia varies in severity and can be caused by a number of conditions and diseases, such as stroke, traumatic brain injury, dementia, Parkinson’s disease, multiple sclerosis, and treatment of head and neck cancer or trauma.1 The most common complications are aspiration pneumonia, malnutrition and dehydration.2 Aspiration pneumonia is a subset of pneumonia caused by inhalation of substances such as liquid and/or food into the lungs when the swallowing mechanism does not function properly. It requires hospitalization and is associated with 10% in-hospital mortality and high hospitalization cost, estimated at approx. $30,000 per case.3 An MBS study is performed by a team comprised of a speech language pathologist (SLP) and a radiologist to identify issues with a patient’s swallowing mechanism. During an MBS, the patient swallows products with different thicknesses containing a barium x-ray contrast agent, while the Radiologist takes fluoroscopic x-ray images. “The FDA approval of VARIBAR® THIN LIQUID (barium sulfate) for oral suspension represents an important event for patients who suffer from dysphagia and require a modified barium swallow study to determine their best management,” said Alberto Spinazzi, MD, Senior Vice President, Chief Medical and Regulatory Officer, Bracco Group. “FDA has now granted approval to the entire line of the VARIBAR imaging agents. This means that all VARIBAR products meet the safety, efficacy and quality standards of the FDA. We are proud of the fact that VARIBAR products are the only imaging agents approved for use in MBS studies. This line of ready-to-use* imaging agents has a fixed concentration of barium sulfate and standardized and premeasured viscosities, to guarantee reproducibility and accurate comparisons between initial and follow-up studies.” *VARIBAR THIN LIQUID (barium sulfate) oral suspension requires reconstitution prior to use Please see Important Safety Information below. Indications and Usage: IMPORTANT SAFETY INFORMATION: Please consult full Prescribing Information for VARIBAR THIN LIQUID (barium sulfate) for oral suspension and the VARIBAR product family at https://imaging.bracco.com/us-en/products/fluoroscopy/varibar You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/Safety/MedWatch/default.htm 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 offers a product and solution portfolio for all key diagnostic imaging modalities: 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.
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