Sonus gets another FDA action letter

AuntMinnie.com staff writers
Mar 13, 2000

Ultrasound contrast agent developer Sonus Pharmaceuticals has received an action letter from the Food and Drug Administration requesting reanalysis of certain data that may affect product labeling for the firm's EchoGen agent.

The letter is the latest in an ongoing regulatory saga for the Bothell, WA-based firm. Sonus had received an approvable letter for EchoGen in April 1999 indicating that the product could be approved once certain conditions were satisfied.

In September 1999 Sonus submitted a response to the approvable letter, and believed that it had addressed all of the FDA's concerns in the response, according to president and CEO Michael Martino. Sonus will now meet with the agency to discuss how it can best respond to the latest letter.

By AuntMinnie.com staff writers
March 14, 2000

Copyright © 2000 AuntMinnie.com

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