Forest/Pierre Fabre now aiming for Q4 levomilnacipran MDD filing
This article was originally published in Scrip
Executive Summary
Forest Laboratories and Pierre Fabre Medicament plan to file a new drug application (NDA) for levomilnacipran for the treatment of adults with major depressive disorder (MDD) with the US FDA by the end of this year, after the third out of four Phase III trials produced positive top-line results. This timing is a little later than the mid-2012 date previously given, and follows a difficult development programme with the product.