Nycomed submits ultrasound agent to FDA:
This article was originally published in Clinica
Executive Summary
Nycomed Amersham Imaging has submitted its Sonazoid ultrasound contrast agent to the US FDA for approval. The new drug application included data from 1,300 patients in US and European trials and the company will submit an application for European approval later this year. Sonazoid is for heart and liver applications and Nycomed is also investigating its use in myocardial perfusion imaging. Daiichi Pharmaceutical, Nycomed's Japanese partner in ultrasound, has completed Phase I trials for Sonazoid in that country.