Healthcare Industry News: HSMN NewsFeed
News Release - August 5, 2019
Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR(R) THIN LIQUID (barium sulfate) for oral suspensionVARIBAR THIN LIQUID (barium sulfate) for oral suspension completes the new drug approval (NDA) Program of the VARIBAR® line of imaging agents for use in modified barium swallow studies.
MONROE TOWNSHIP, N.J., Aug. 5, 2019 -- (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 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:
VARIBAR® THIN LIQUID (barium sulfate) for oral suspension is indicated for use in modified barium swallow examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients.
IMPORTANT SAFETY INFORMATION:
For Oral Administration. This product should not be used in patients with known or suspected perforation of the GI tract, known obstruction of the GI tract, high risk of aspiration, 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 THIN LIQUID (barium sulfate) for oral suspension and the VARIBAR product family at 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 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. Bhattacharyya N. The prevalence of dysphagia among adults in the United States. Otolaryngology– Head and Neck Surgery 2014; 151: 765–769
2. Schindler A, Ginocchio D, Ruoppolo G. What we don't know about dysphagia complications? Rev Laryngol Otol Rhinol (Bord) 2008;129:75-88
3. Wu C-P, Chen Y-W, Wang M-J, and Pinelis E. National Trends in Admission for Aspirational Pneumonia in the United States, 2002-2012; AnnalsATS 2017, 14: 874-879
Source: Bracco Diagnostics
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