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FDA panel recommends approval of FS069

Article

A Food and Drug Administration advisory committee last week recommendedthe approval of FS069, a second-generation ultrasound contrastagent developed by Molecular Biosystems of San Diego. The productnow awaits a final decision by the FDA, which could come

A Food and Drug Administration advisory committee last week recommendedthe approval of FS069, a second-generation ultrasound contrastagent developed by Molecular Biosystems of San Diego. The productnow awaits a final decision by the FDA, which could come in thenext several months.

The action by the Radiology Device Advisory Panel comes onlymonths after FS069's premarket approval application was filedby MBI and its U.S. marketing partner for the agent, Mallinckrodtof St. Louis (SCAN 11/6/96). FS069's path through the FDA approvalprocess has been considerably shorter than MBI's previous contrastagent, Albunex, which underwent nearly four years of PMA reviewbefore it was finally approved by the agency in 1994 (SCAN 8/31/94).

Industry analysts believe that FS069 has much more potentialthan Albunex, which was the first ultrasound contrast agent onthe U.S. market. Sales of Albunex have been disappointing, dueto its short duration and the complexity required to handle theproduct.

FS069 is designed to enhance visualization of endocardial borderdelineation and left ventricular opacification during echocardiographyexams. This capability is important in diagnosing regional andglobal wall-motion abnormalities, which may be a measure of theseverity of coronary artery disease. The advisory committee alsorecommended approval of FS069 for enhancing Doppler signals. MBIplans to pursue additional cardiac imaging capabilities for FS069,including myocardial perfusion and enhancement of liver and kidneyultrasound imaging.

In making its decision, the advisory panel took the positionthat the data supporting the safety and effectiveness of FS069were so compelling that the agent was recommended to the FDA withoutconditions, including no postmarket surveillance follow-up.

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