NDA 216354, held by Teva. Deutetrabenazine.
As of Nov 14, 2026, NDA 216354 (Austedo Xr), held by Teva, was first approved by FDA on Feb 17, 2023, with 3 approved supplements and 0 published complete response letters.
AUSTEDO XR and AUSTEDO are indicated in adults for the treatment of: chorea associated with Huntington’s disease tardive dyskinesia AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease Tardive dyskinesia
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 17, 2023 | Original applicationNew dosage form · Standard review | Approved |
| Austedo Xr6MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Austedo Xr12MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Austedo Xr24MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Austedo Xr30MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Austedo Xr36MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Austedo Xr42MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Austedo Xr48MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Austedo Xr18MG · tablet, extended release;oral | Deutetrabenazine | RxReference drug |
| Feb 28, 2025 | Supplement 8Labeling · Standard review | Approved | |
| Jul 1, 2024 | Supplement 7Manufacturing | Approved | |
| May 29, 2024 | Supplement 6Manufacturing | Approved | |
| Feb 17, 2023 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
