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Austedo Approval History

FDA Approved: Yes (First approved April 3, 2017)
Brand name: Austedo
Generic name: deutetrabenazine
Dosage form: Tablets
Previous Name: SD-809
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Huntington's Disease, Tardive Dyskinesia

Austedo (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated for the treatment of chorea associated with Huntington’s disease and the treatment of tardive dyskinesia.

Development History and FDA Approval Process for Austedo

DateArticle
Aug 30, 2017Approval Teva Announces FDA Approval of Austedo (deutetrabenazine) Tablets for the Treatment of Tardive Dyskinesia in Adults
Apr  3, 2017Approval Teva Announces FDA Approval of Austedo (deutetrabenazine) for the Treatment of Chorea Associated with Huntington’s Disease
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
Aug 18, 2014Auspex Pharmaceuticals Completes Enrollment in Phase 3 Registration Clinical Trial of SD-809
Jul 17, 2014Auspex Pharmaceuticals Initiates Pivotal Phase 2/3 Clinical Trial for SD-809 in Tardive Dyskinesia

Further information

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