Acromegaly
Tercica reports NDA for Somatuline Autogel for acromegaly accepted for filing by U.S. FDA
Published in Surgery Litigation and Law Weekly, February 16th, 2007
Based on the prescription drug user fee act (PDUFA) guidelines, Tercica expects the U.S. FDA will complete its review or otherwise respond to the Somatuline Autogel NDA by the fall of 2007.
Somatuline Autogel has received a marketing approval in Canada and is being launched by Tercica under its distribution license agreement with Ipsen,...
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