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# Teva Resubmits NDA for Huntington’s Drug
- URL: https://www.fdaweb.com/teva-resubmits-nda-for-huntingtons-drug/
- Published: 2016-10-20T12:00:00.000Z
- Updated: 2026-09-14T21:41:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137126

Teva Pharmaceutical Industries has resubmitted an NDA for SD-809 (deutetrabenazine) for treating chorea associated with Huntington disease. The agency has set a user fee review target date of 4/3/2017.

In June, FDA issued Teva a [Complete Response Letter](https://www.fdaweb.com/teva-gets-complete-response-letter-for-huntington-drug/) on the original submission, asking that it examine blood levels of certain metabolites. “These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine,” the company said at the time, adding that no new clinical trials had been requested.

Teva says it is continuing development programs involving SD-809 and its use in treating patients with tardive dyskinesia and Tourette syndrome. The company is currently conducting a Phase 3 efficacy and safety study in patients with moderate to severe tardive dyskinesia known as AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia) and expects additional data from this study later in 2016, followed by a regulatory submission shortly thereafter. SD-809 has also been granted orphan drug designation for treating Tourette’s in the pediatric population, it says, adding that a study is being planned for treating tics associated with the condition.