Alliance Pharmaceutical responds to FDA
The San Diego developer of the ultrasound contrast medium Imavist has provided documentation requested by the FDA to support the companyπs application to market the agent in the U.S. The FDA had reviewed a new drug application for Imavist and found
The San Diego developer of the ultrasound contrast medium Imavist has provided documentation requested by the FDA to support the companyπs application to market the agent in the U.S. The FDA had reviewed a new drug application for Imavist and found it to be approvable upon satisfactory response to issues identified in the review process. Alliance and Schering of Germany are developing Imavist jointly. Alliance believes the current submission fully addresses the issues noted by the FDA, and the company hopes to receive final approval later this year.