US FDA approves Orexo's Edluar
Swedish drugmaker Orexo says that its new insomnia treatment Edluar (zolpidem) has been approved by the US Food and Drug Administration.
The product is an oral sublingual formulation of zolpidem, an off-patent insomnia drug developed by Sanofi-Aventis. The FDA cleared Edluar in 5mg and 10mg tablet strengths for the short-term treatment of insomnia characterized by difficulties with sleep initiation.
Orexo's partner Meda acquired the exclusive worldwide commercialization license for Edluar last year and they expect to launch the product in the US market during the second half of 2009. The originator will receive royalties on Meda's sales of Edluar. This approval triggers a milestone payment from Meda of $5.0 million and is based upon the product labeling.
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