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SD-809 Approval Status

SD-809 (deutetrabenazine) is an investigational vesicular monoamine 2 transporter (VMAT2) inhibitor intended for the treatment of chorea associated with Huntington disease.

Development Status and FDA Approval Process for SD-809

DateArticle
Oct 20, 2016Teva Announces FDA Acceptance of Resubmitted NDA for SD-809 for Treatment of Chorea Associated with Huntington Disease
May 31, 2016Teva Receives Complete Response Letter for NDA for SD-809 for the Treatment of Chorea Associated with Huntington Disease
Nov  9, 2015Teva Announces Breakthrough Therapy Designation for SD-809 Granted by FDA for the Treatment of Tardive Dyskinesia
Aug 12, 2015Teva Announces FDA Acceptance of NDA for SD-809 for Treatment in Huntington Disease

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