Sonus drops EchoGen, refocuses

SNUS withdrew its NDA for its EchoGen perflenapent ultrasound contrast agent and discontinued clinical activity for the product. The company said that discussions with the FDA indicated that significant additional work would be required in order to receive approval for EchoGen. Following several interactions with the FDA regarding EchoGen, including 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 reanalysis of certain data for the product (see BioCentury, March 20). ...