Healthcare Industry News: U.S. Food and Drug Administration
News Release - July 28, 2017
Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR(R) NECTAR (barium sulfate) Oral SuspensionVARIBAR products are the only premixed, premeasured and precise barium contrast agents in the U.S. for modified barium swallow (MBS) studies
MONROE TOWNSHIP, N.J., July 28, 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 the U.S. Food and Drug Administration (FDA) approved VARIBAR NECTAR (barium sulfate) oral suspension for use in modified barium swallow (MBS) examinations to evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders.
Trouble with swallowing is a frequent cause of morbidity and disability in all age groups, resulting from a wide spectrum of medical conditions, including patients with congenital abnormalities, infections, or connective tissue diseases, patients recovering from stroke, brain trauma, and/or coma, patients with masses of the tongue, pharynx, larynx, or retropharyngeal region, and follow-up of surgery and/or radiotherapy of brain or head and neck cancer. If not timely and properly detected and assessed, swallowing disorders may lead to dehydration, weight loss, aspiration pneumonia, airway obstruction, severely reduced quality of life, and even death.1
The MBS study, a radiological examination of the swallowing process, is key to determine the nature and extent of the swallowing disorder. The VARIBAR products are oral agents that provide adequate visibility of anatomical structures and the swallowing process during the MBS examination, and simulate different liquid and food consistencies to assess the type and severity of the swallowing disorder.
"Accurate and reliable measure of the swallowing process is key for proper patient management. The VARIBAR product line was developed in cooperation with speech language pathologists and radiologists to optimize the diagnostic performance and reliability of MBS studies," said Alberto Spinazzi, MD, Senior Vice President, Global Medical and Regulatory Affairs, Bracco Group. "This FDA approval provides physicians and patients with yet another FDA approved option within the VARIBAR product line, and reinforces our dedication to meet medical needs."
Spinazzi continued, "This FDA approval is a testament to the quality, safety and efficacy of this product family, which provides unmatched convenience with reproducible results."
Each VARIBAR product viscosity was formulated to provide pleasant, easily tolerated flavors, textures and consistencies, to help elicit a more natural swallowing action in patients who undergo an MBS study. The VARIBAR NECTAR product (Target Viscosity 300 CPS), formulated with an apple flavor for patient compliance, is one of the five viscosity ranges within the VARIBAR product line. The VARIBAR NECTAR product was developed specifically to provide the minimal coating properties necessary to clearly visualize the dynamic swallowing process.
VARIBAR products afford many benefits, including:
- Ensured consistency in barium density with 40% w/v across every formulation2-4
- Eliminating the need for additional food products and thickening agents2,5-7
- Clarifying viscosity terminology through scientific measurement versus subjective recipes2,3,5-8
- Avoiding undesirable coating inherent to traditional GI barium preparations4,9
- Supporting high-quality imaging4
- Enabling reproducible results2-10
Please see Important Safety Information below.
Indications and Usage:
VARIBAR (barium sulfate) 40% (w/v) products are indicated for use in radiography of the esophagus, pharynx and hypopharynx. VARIBAR (barium sulfate) 40% (w/v) is indicated for adult use only.
VARIBAR PUDDING (barium sulfate) oral paste is 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.
VARIBAR NECTAR (barium sulfate) 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 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 the VARIBAR NECTAR product at http://www.braccoimaging.com/sites/braccoimaging.com/files/technica_sheet_pdf/us-en-2016-07-20-spc-varibar-nectar.pdf
Please consult full Prescribing Information for the VARIBAR product line at: http://www.braccoimaging.com/us-en/products/fluoroscopy/varibar
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.
*VARIBAR THIN LIQUID BARIUM SULFATE SUSPENSION (40% w/v after reconstitution) (Target Viscosity 4 CPS) is supplied as a powder and constituted to a standard volume with water.
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 Jaffer NM, Ng E, Au FW, Steele CM. Fluoroscopic evaluation of oropharyngeal dysphagia: anatomic, technical, and common etiologic factors. AJR Am J Roentgenol 2015; 204: 49-58
2 VARIBAR® HONEY Barium Sulfate Suspension (40% w/v, 29% w/w) (Target Viscosity 3000 CPS) full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; March 2015.
3 VARIBAR® THIN LIQUID BARIUM SULFATE SUSPENSION (40% w/v after reconstitution) (Target Viscosity 4 CPS) full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; May 2014.
4 Steele CM, Barbon C, Namasivayam A. Best Practices in Videofluoroscopy. Dysphagia Cafe. http://dysphagiacafe.com/2014/03/19/best-practice-in-videofluoroscopy-by-dr-catriona-steele-carly-barbon-and-ashwini-namasivayam/. Accessed June 10, 2016.
5 VARIBAR® THIN HONEY Barium Sulfate Suspension (40% w/v, 29% w/w) (Target Viscosity 1500 CPS) full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; June 2015.
6 VARIBAR® NECTAR (barium sulfate) oral suspension full Prescribing Information. Monroe Twp., NJ: Bracco Diagnostics Inc.; March 2014.
7 VARIBAR® PUDDING (barium sulfate) oral paste full Prescribing Information. Monroe Twp, NJ: Bracco Diagnostics Inc.; Oct. 2016.
8 Robbins J, Nicosia M, Hind JA, Gill GD, Blanco R, Logemann J. Defining physical properties of fluids for dysphagia evaluation and treatment. ASHA, Special Interest Division 13. Swallowing and Swallowing Disorders (Dysphagia) Newsletter. 2002;11(2):16-19.
9 Hind J, Divyak E, Zielinski J, et al. Comparison of standardized bariums with varying rheological parameters on swallowing kinematics in males. J Rehabil Res Dev. 2012;49(9):1399 1401.
10 Steele CM, Molfenter SM, Péladeau-Pigeon M, Stokely S. Challenges in preparing contrast media for videofluoroscopy. Dysphagia. 2013;28(3):464-467. doi:10.1007/s00455-013-9476-7.
Source: Bracco Diagnostics
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