Tuesday, July 29, 2008

Orexo: 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.

The details can be read here.

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