Pharmaceutical Business review

Meda wins FDA approval for insomnia drug

According to Meda, the Edluar contains the well-known substance zolpidem and uses Orexo’s patented sublingual tablet formulation. The collaboration agreement with Orexo entitles it to a milestone payment at the FDA approval. That milestone is $5 million based on the product labeling.

No further milestone payments for Edluar are expected to be due Orexo. Product launch in the US is anticipated to start during second half of 2009.