Sanofi pulls all filings after ODAC rejection of semuloparin
This article was originally published in Scrip
Executive Summary
Sanofi has withdrawn its marketing authorisation application (MAA) for Mulsevo (semuloparin sodium) in Europe. The EMA says it has been formally notified by Sanofi of its decision, and that in its withdrawal letter, Sanofi had stated that it was withdrawing all applications globally "following comments by regulatory agencies".