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In addition, it is commonly used off-label for insomnia, and the company is applying for FDA approval for the treatment of .The drug’s approval for bipolar depression was particularly valuable, because it opened the door to off-label use in garden variety, unipolar depression—a much bigger market than bipolar depression.
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At this point, Astra Zeneca needs to do the right thing, which is to unseal the secret documents.
Only then will the company be able to clear its name.
The problem is that the “BOLDER” studies, which formed the basis for FDA approval, had a glaring weakness.
The patients who were enrolled were very different from the patients we see in clinical practice.
It is possible that in order to avoid disclosure of embarrassing documents, the company will settle the case and prevent a trial.
Earlier this year, the realms of law and new media collided when Lori Drew was hit with federal charges for creating a fake My Space page and harassing a neighboring teenager, who then committed suicide.
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