Swedish drugmaker Meda AB (OMX: MEDA A) says that is Edluar, an oral sublingual formulation of zolpidem, has received registration approval in Europe via the decentralized procedure with Sweden acting as reference member state. Edluar is used for treating sleep disorders. National registration processes will now follow in each country., the company stated, noting that the first launches are expected early next year.
Edluar, for which Meda gained global rights from fellow Swedish firm Orexo in 2008, was launched in the US market in 2009 and the launch in Canada (brand Sublinox) started early 2012. Edluar/Sublinox uses a unique, patented sublingual tablet formulation for fast and effective absorption. “With this approval, we cover the key markets. We will now continue the registration process on other interesting markets”, said Anders Lonner, chief executive of Meda.
Debiopharm and Ascepion Pharma collaborate
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