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Sonus Pharmaceuticals

This article was originally published in The Gray Sheet

Executive Summary

Firm receives action letter extending approvable status of EchoGen ultrasound contrast agent (perflenapent injectable emulsion) pending a "reanalysis of certain data that may affect product labeling," Sonus announces March 14. Sonus received an approvable letter in April 1999 for echocardiographic evaluation of left ventricular endocardial border delineation and left ventricular chamber opacification. The company plans to meet with the agency to clarify FDA's additional requests
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