Genzyme drops Sepracoat in US after FDA vote:
This article was originally published in Clinica
Executive Summary
Genzyme is to discontinue the development of Sepracoat, its coating solution, in the US, resulting in write-off of around $5 million. In May 1997 the FDA voted against granting approval for the product, which is designed to reduce adhesion formation resulting from indirect trauma during surgery. The product has been CE-marked since 1996. The US company maintains the action will have no impact on the manufacture and sales of related product, Seprafilm, its surgical adhesion preventative, which received FDA approval in mid-1996.