This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryFirm is planning a fall launch for its ultrasound contrast agent perflutren following approval July 31. FDA cleared the agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve delineation of the left ventricular endocardial border. DuPont plans an sNDA for kidney and liver imaging. The indications were requested in the 1998 NDA, but FDA asked for further information
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