Bracco receives FDA approval for VARIBAR® NECTAR oral suspension

Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., has received clearance from the U.S. Food and Drug Administration (FDA) for VARIBAR NECTAR (barium sulfate) oral suspension to be used in modified barium swallow (MBS) examinations. These examinations evaluate the oral and pharyngeal function and morphology in adult and pediatric patients with known or suspected swallowing disorders.

A modified barium swallow study is key to determine the nature and extent of a 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, according to Bracco.

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.

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.

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