EchoGen perflenapent ultrasound contrast agent regulatory update

SNUS withdrew its NDA and discontinued clinical activity for EchoGen, and said significant additional work would be required to receive FDA approval. Following an approvable letter in April 1999 for echocardiographic evaluation of left ventricular endocardial border delineation and left ventricular chamber opacification, SNUS earlier this year responded to the agency's March action letter requesting a re-analysis of certain data for the product (see BioCentury, March 20). Under a May settlement of patent infringement litigation, SNUS is eligible for royalties on ultrasound contrast agents sold by Molecular Biosystems Inc. (MBIO, San Diego, Calif.), Mallinckrodt Inc. (MKG, St. Louis, Mo.) and Nycomed Imaging AS (Oslo, Norway) worldwide, except certain Pacific Rim countries. ...