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In Brief: Mallinckrodt/MBI

This article was originally published in The Gray Sheet

Executive Summary

Mallinckrodt/MBI: File EU marketing application for FS069, the firms' cardiovascular ultrasound contrast agent designed to enhance visualization of endocardial borders and left ventricular opacification, and to improve doppler signal enhancement. A premarket approval application for FS069 is under review at FDA. The agency's Radiological Devices Panel voted 6-1 to recommend that FDA approve the agent without conditions at its meeting earlier this month ("The Gray Sheet" March 3, p. 9)...

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