Austedo Teva GmbH · Authorised · authorised 8 Jan 2026 · ATC N07XX16
Therapeutic indication (EMA)
Treatment of moderate to severe tardive dyskinesia in adults.
Active substance
Deutetrabenazine
- US FDA 4
- EMA 1
- US price lines 11
- Safety 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| AUSTEDO | 6MG; 9MG; 12MG | tablet · oral | TEVA BRANDED PHARM | Prescription | 3 Apr 2017 |
| AUSTEDO | 6MG; 9MG; 12MG | tablet · oral | TEVA BRANDED PHARM | Prescription | 30 Aug 2017 |
| AUSTEDO XR | 6MG; 12MG; 24MG; 30MG; 36MG; 42MG; 48MG; 18MG | tablet, extended release · oral | TEVA | Prescription | 17 Feb 2023 |
| DEUTETRABENAZINE | 6MG; 9MG; 12MG | tablet · oral | AUROBINDO PHARMA LTD | Discontinued | 26 Dec 2024 |
EMA European Union — centrally authorised medicines
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | AUSTEDO 12 MG TABLET | $125.02961 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO 6 MG TABLET | $83.20001 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO 9 MG TABLET | $93.97081 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 12 MG TABLET | $166.76453 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 18 MG TABLET | $251.16057 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 24 MG TABLET | $250.63121 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 30 MG TABLET | $332.33999 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 36 MG TABLET | $416.75609 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 42 MG TABLET | $498.13485 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 48 MG TABLET | $500.84367 | per EA | 23 Sep 2026 |
| US NADAC | AUSTEDO XR 6 MG TABLET | $83.0345 | per EA | 23 Sep 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- US FDA 26 Nov 2024 AUSTEDO — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 1 Jul 2024 AUSTEDO XR — safety-related labeling change
Labeling sections changed: Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.