Product Dossier
AUSTEDO
Product Dossier for AUSTEDO (deutetrabenazine, Teva Pharma). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Teva Pharma
- Active ingredient: deutetrabenazine
- Therapeutic area: Neurology
- Same area: GILENYA
- Same area: RIVOTRIL
What it is
AUSTEDO is a modified release tablet containing deutetrabenazine, available in strengths of 6 mg, 9 mg and 12 mg.
Approved indications —
Chorea associated with Huntington's disease — Tardive dyskinesia in adults
Regulatory history
AUSTEDO received regulatory approval on 26 May 2021. The three tablet strengths were first listed on the ARTG on 2 June 2021. The product was considered by PBAC in November 2017 and not recommended, with uncertainty noted regarding clinical benefit and cost-effectiveness. PBAC again considered the application in March 2021 and did not recommend listing.