Genzyme Seprafilm approval will allow broader use than panel recommendation, company exec says.
This article was originally published in The Gray Sheet
Executive Summary
GENZYME SEPRAFILM APPROVAL WILL BE BROADER THAN PANEL RECOMMENDATION for the post-operative adhesion reduction product, the firm says. Speaking at a June 25 meeting of the Food and Drug Law Institute in Washington, D.C., Genzyme VP, Clinical, Medical and Regulatory Affairs Richard Moscicki, MD, said the company has "worked very successfully with the FDA reviewers -- despite working within the restraints of the advisory panel -- to develop a very broad, appropriate label for the use of Seprafilm" during open abdominal surgery.
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