This article was originally published in The Gray Sheet
Sonus Echogen: FDA review of a new drug application for the fluorocarbon-based cardiology/radiology ultrasound contrast agent requires additional manufacturing process information, the Bothell, Washington firm reports Feb. 26. The agency is seeking additional data on the chemistry and analytical methods validation and re-analysis of some of the NDA's animal and clinical data. Sonus anticipates taking "a few weeks" to comply with the request, although the company notes that the time period could be extended due to circumstances beyond its control. Echogen, which has granted marketing rights to Abbott ("The Gray Sheet" Sept. 15, I&W-11), was informed in October that review of the NDA by the Medical Imaging Drugs Advisory Committee was not necessary...
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