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March 16, 2009

Orexo Receives FDA Green Light for Insomnia Drug

  • FDA approved Edluar, an insomnia therapy from Orexo. Partner, Meda, will have to pay Orexo $5 million according to their agreement inked in April 2008.

    Edluar 5 mg and 10 mg sublingual tablets is indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. Meda expects to launch the drug in the second half of this year.

    Meda gained worldwide rights to Edluar and a nasal spray for rhinitis with an up-front $90 million fee. The company also agreed to pay up to $30 million if Edluar was sanctioned. Labeling under the current approval triggered only $5 million. Sales-based success fees could total $60 million.

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