In Brief: Genzyme Sepracoat
This article was originally published in The Gray Sheet
Executive Summary
Genzyme Sepracoat: Premarket approval application will be submitted to FDA later this year for the coating solution, which is intended to reduce postoperative adhesion formation resulting from "indirect" surgical damage in abdominal, gynecologic and cardiovascular operations. FDA has indicated that the PMA will be granted expedited review, Genzyme says. The agency also will expedite review of Genzyme's PMA for the Seprafilm bioresorbable membrane for treatment of post-op adhesions from "direct" surgical trauma, according to the firm. The PMA was submitted in August...