Alliance Pharmaceutical's Imavist
This article was originally published in The Gray Sheet
Executive SummaryUltrasound contrast agent FDA "approvable" letter completes review of the firm's new drug application, the firm announces Aug. 21. The NDA incorporated data from two Phase III multi-center studies on endocardial border delineation in about 500 U.S. patients and was submitted in October 1999. The product was developed jointly by Alliance and The German firm Schering AG. Alliance says it will "work closely with FDA to satisfy the remaining requirements" before final approval of the drug, which will be marketed by Schering
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