Contrast agent developer Sonus Pharmaceuticals has announced that the Food and Drug Administration has accepted as complete for review its response to the agency's March 2000 action letter on Sonus' EchoGen ultrasound agent. The FDA's action letter requested reanalysis of certain data that may affect product labeling for the firm's EchoGen agent.
The FDA has indicated that it will complete its review of the Bothell, WA-based vendor's response by the end of October, according to Sonus. Although Sonus was hoping for a shorter response time, the firm intends to work closely with the FDA during the review, according to president and CEO Michael Martino.
By AuntMinnie.com staff writers
May 24, 2000
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