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Molecular Biosystems' Albunex

Executive Summary

Contrast imaging agent for use with ultrasound is "approvable" at FDA, company announces April 28. The agency's letter asks the firm to make some labeling changes and conduct post-approval studies "relating to the nature and frequency of any reported 'adverse device effects' (ADEs)" as requested by FDA's Radiological Devices Panel in July 1992. MBI says the ADEs that occurred during clinical trials "were both minor and resolved without treatment," and the San Diego-based company will respond to FDA "in the next few days." Albunex will be marketed in the U.S. by Mallinckrodt Medical



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