Sonus meets with FDA on EchoGen

It could be as long as 10 months before Sonus Pharmaceuticals gets its EchoGen ultrasound contrast agent on the market, as it moves to comply with the Food and Drug Administration’s concerns about the agent’s new drug application (NDA). Sonus of Bothell, WA, met with the FDA on April 27 to discuss the NDA after receiving a not-approvable letter for EchoGen in February (SCAN 3/18/98).

Sonus reported that it plans to submit an amendment to EchoGen’s NDA in the next two to four months to respond to the FDA’s concerns regarding the manufacturing processes for EchoGen, including chemistry and analytical methods validation, as well as the company’s analysis of animal and clinical data in the application. Once Sonus submits the amendment, the FDA could take up to six months to review it before rendering a decision.