The FDA has accepted for filing the registration application for Sublinox™
The submitted registration application for SublinoxTM (OX22) has been accepted by the FDA as complete for substantive review after initial evaluation. SublinoxTM contains the well-known active substance zolpidem and is based on Orexo’s sublingual technology, involving a rapidly disintegrating tablet placed under the tongue.Meda AB acquired the exclusive world-wide commercialization rights for SublinoxTM on April 14, 2008. “This FDA’s acceptance increases the chances for a registration approval during 2009”, said Anders Lönner, CEO of Meda.The data supporting the product includes a