Edluar receives FDA approval

The US Food and Drug Administration (FDA) has approved Edluar (formerly Sublinox) for the short-term treatment of insomnia. The product contains the well-known substance zolpidem and uses Orexo’s patented sublingual tablet formulation. The collaboration agreement with Orexo entitles them to a milestone payment at FDA approval. That milestone is 5 MUSD based on the product labelling. No further milestone payments for Edluar are expected to be due Orexo. Product launch in the US is anticipated to start during 2nd half of 2009.