STOCKHOLM, Sweden--(BUSINESS WIRE)--Regulatory News:
This 505 (b) (2) NDA which is based on the clinical data completed October 2007. This data shows unique properties for Sublinox™ (OX22) in insomnia patients, including an earlier onset of sleep as compared to Ambien®. In addition to the earlier onset of sleep, the data also shows maintenance of sleep throughout the night. Sublinox™ (OX22) also offers a more convenient way of administration compared to oral tablets since it does not need to be swallowed with water. The first evaluation will take about two months and FDA will thereafter decide if the file is accepted for final evaluation.
