Sonus to meet FDA on EchoGen
Ultrasound contrast developer Sonus Pharmaceuticals has a meeting with the Food and Drug Administration scheduled for April 27 to discuss the company's regulatory filing for EchoGen. The meeting was called as part of the Bothell, WA, company's
Ultrasound contrast developer Sonus Pharmaceuticals has a meeting with the Food and Drug Administration scheduled for April 27 to discuss the company's regulatory filing for EchoGen. The meeting was called as part of the Bothell, WA, company's discussions with the FDA over EchoGen's new drug application. The FDA in February said it required additional information on the NDA before it could be approved (SCAN 3/18/98).
Sonus also announced that EchoGen's medical marketing application (MMA) was scheduled to be reviewed in late March by Europe's Committee for Proprietary Medicinal Products (CPMP), which makes recommendations to the European Medicines Evaluation Agency. EMEA approval would allow Sonus to market EchoGen in the 15 nations of the European Union.