Nycomed submits ultrasound contrast NDA
Contrast agent developer Nycomed Amersham hopes soon to join the ultrasound contrast race. The Buckingham, U.K.-based firm has submitted a new drug application (NDA) to the Food and Drug Administration for Sonazoid, an ultrasound contrast agent formerly
Contrast agent developer Nycomed Amersham hopes soon to join the ultrasound contrast race. The Buckingham, U.K.-based firm has submitted a new drug application (NDA) to the Food and Drug Administration for Sonazoid, an ultrasound contrast agent formerly called NC100100. In support of its application, Nycomed has submitted clinical data demonstrating echocardiographic improvement in endocardial border delineation and left ventricular opacification when Sonazoid is used. Nycomed performed clinical trials for the agent on approximately 1300 patients in Europe and the U.S.
Nycomed has been defending patents covering the agents technology since 1997, when it became embroiled in a dispute with San Diego-based Molecular Biosystems and St. Louis-based Mallinckrodt (SCAN 4/29/98).
Developed for use in such cardiology and radiology applications as heart and liver imaging, Sonazoid is also being investigated for use in imaging myocardial perfusion. The companys Japanese partner in ultrasound contrast agent R&D, Daiichi Pharmaceutical, has completed phase I trials for liver and heart imaging applications for Sonazoid. Nycomed plans to submit an equivalent clearance document for the agent in Europe later this year.