Alliance Pharmaceutical has submitted follow-up documentation to the Food and Drug Administration regarding the Imavist echocardiography contrast agent Alliance is co-developing with German pharmaceutical firm Schering. The FDA had found the San Diego-based firm's new drug application (NDA) for Imavist to be approvable upon satisfactory response to issues identified in the review process, according to Alliance.
Alliance believes the current submission fully addresses the issues noted by the FDA, and hopes to receive final approval to market Imavist in the U.S. later this year. Imavist is designed to help patients with suboptimal echocardiograms via opacification of the left ventricle and delineation of the endocardial border. In addition to seeking approval for cardiac applications, Alliance intends to pursue radiology indications for Imavist, including ultrasound imaging of the prostate and liver, according to chairman and CEO Duane Roth.
By AuntMinnie.com staff writersAugust 20, 2001
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