Bracco Diagnostics wins US FDA approval for VARIBAR NECTAR for modified barium swallow (MBS) studies.
M2 EQUITYBITES-July 31, 2017-Bracco Diagnostics wins US FDA approval for VARIBAR NECTAR for modified barium swallow (MBS) studies
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Diagnostic imaging company Bracco Diagnostics Inc reported on Friday the receipt of approval from the US Food and Drug Administration (FDA) for VARIBAR NECTAR (barium sulfate) oral suspension to evaluate the oral and pharyngeal function and morphology in adult and paediatric patients with known or suspected swallowing disorders under the modified barium swallow (MBS) examinations study.
In conjunction, the MBS study, which is a radiological examination of the swallowing process, is key to determine the nature and extent of the swallowing disorder, which is a frequent cause of morbidity and disability in all age groups, resulting from a wide spectrum of medical conditions and if not timely and properly detected and assessed, may lead to dehydration, weight loss, aspiration pneumonia, airway obstruction, severely reduced quality of life and even death, added the company.
According to the company, 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. 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, stated the company.
Additionally, the remaining four VARIBAR products include VARIBAR PUDDING (barium sulfate) oral paste, VARIBAR THIN HONEY BARIUM SULFATE SUSPENSION (40% w/v, 29% w/w) (Target Viscosity 1500 CPS), VARIBAR THIN LIQUID BARIUM SULFATE SUSPENSION (40% w/v after reconstitution) (Target Viscosity 4 CPS)* and VARIBAR HONEY BARIUM SULFATE SUSPENSION (40% w/v, 29% w/w) (Target Viscosity 3000 CPS), concluded the company.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Jul 31, 2017|
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