FDA asks Sonus for more EchoGen info
Sonus Pharmaceuticals last week announced that the Food and Drug Administration has informed the company that it has completed its review of the company's EchoGen ultrasound contrast agent, but requires additional information before it can sign off on
Sonus Pharmaceuticals last week announced that the Food and Drug Administration has informed the company that it has completed its review of the company's EchoGen ultrasound contrast agent, but requires additional information before it can sign off on the product. The Bothell, WA, firm said it should be able to provide the information in the next several weeks.
Sonus said the FDA's request concerned the manufacturing process for EchoGen, including chemistry and analytical methods validation. The agency also asked Sonus to provide a reanalysis of some of the animal and clinical data in the product's new drug application. None of the FDA's questions concern the clinical safety of EchoGen, according to Sonus, and the company believes that the agency will approve the product once the additional questions are addressed.
Whether the information request will delay the commercialization of EchoGen is unclear, and Sonus executives were unavailable for comment as of press time. The company is hoping to get the product to market quickly to compete with Optison from Molecular Biosystems, which began shipping shortly after it was approved in December (SCAN 1/14/98). Wall Street reacted negatively to the news: Sonus shares were at around $25 in midday trading on Feb. 26, the day the news was announced, representing a decline of about 13%.