Austedo XR FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 28, 2023.
FDA Approved: Yes (First approved February 17, 2023)
Brand name: Austedo XR
Generic name: deutetrabenazine
Dosage form: Extended-Release Tablets
Company: Teva Pharmaceuticals USA, Inc.
Treatment for: Tardive Dyskinesia, Huntington's Disease
Austedo XR (deutetrabenazine) is a vesicular monoamine transporter 2 (VMAT2) inhibitor indicated in adults for the treatment of tardive dyskinesia, and chorea associated with Huntington’s disease.
- Austedo XR is an extended-release, once-daily formulation of Austedo, which was first approved in 2017 as a twice-daily formulation.
- Austedo XR is an inhibitor of VMAT2 that works to reduce dyskinesia by depleting monoamines (including dopamine) from the nerve terminals.
- Austedo XR tablets are administered once daily, with or without food.
- The product label for Austedo XR carries a Boxed Warning for an increased risk of depression and suicidal thoughts and behavior in patients with Huntington’s disease. Warnings and precautions associated with Austedo XR include QT prolongation; neuroleptic malignant syndrome; akathisia, agitation, restlessness, and parkinsonism; and sedation/somnolence.
- Common adverse reactions in patients with Huntington’s disease include somnolence, diarrhea, dry mouth, and fatigue.
Common adverse reactions in patients with tardive dyskinesia include nasopharyngitis and insomnia.
Development timeline for Austedo XR
| Date | Article |
|---|---|
| Feb 17, 2023 | Approval Teva Announces FDA Approval of Austedo XR (deutetrabenazine) Extended-Release Tablets, a New Once-Daily Formulation of Austedo |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
