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  • Casual Articles - FDA Deems Vagus Nerve Therapy Approvable as a Treatment for Depression

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    least four adequate antidepressant treatments. In the approvable letter received today by Cybe
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    On February 3, 2005 the U.S. Food and Drug Administration (FDA) notified the manufacturer of the vagus nerve stimulator (Cyberonics, Inc.) that it had deemed its VNS Therapy System approvable as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression in a major depressive episode that has not responded to at least four adequate antidepressant treatments. In the approvable letter received today by Cyber
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    the vagus nerve stimulator (Cyberonics, Inc.) that it had deemed its VNS Therapy System approvable as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression in a major depressive episode that has not responded to at least four adequate antidepressant treatments. In the approvable letter received today by Cybe
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    rovable as a long-term adjunctive treatment for patients over the age of 18 with chronic or recurrent treatment-resistant depression in a major depressive episode that has not responded to at least four adequate antidepressant treatments. In the approvable letter received today by Cybe
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    urrent treatment-resistant depression in a major depressive episode that has not responded to at least four adequate antidepressant treatments. In the approvable letter received today by Cybe
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    least four adequate antidepressant treatments. In the approvable letter received today by Cyberonics, FDA indicated that final approval was conditional on final labeling, final protocols for a post-approval dosing optimization study and patient registry.

    This is an extraordinary announcement and major step for the four million Americans suffering from chronic or treatment-resistant depression towards providing an FDA-approved, informatively labeled, long-term trea

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