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The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.
Australian prescription medicine decision summary
|Submission type|| |
New chemical entity
|Product name|| |
|Active ingredients|| |
|ATC codes|| |
Not yet assigned
|Date of decision|| |
26 May 2021
|Date of entry onto ARTG|| |
2 June 2021
|Original publication date|| |
9 June 2021
|ARTG numbers|| |
330021, 330022 and 330023
|Black Triangle Scheme|| |
Yes. This product will remain in the scheme for 5 years, starting on the date the product is first supplied in Australia.
Teva Pharma Australia Pty Ltd
|Sponsor address|| |
Level 1, 37 Epping Road, Macquarie Park NSW 2113
|Dose forms|| |
Modified release tablet
6 mg, 9 mg and 12 mg
|Other ingredients|| |
Butylated hydroxyanisole, butylated hydroxytoluene, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene oxide, polysorbate 80, povidone, and the printing ink, opacode monogramming ink S-1-17823 black. The 6 mg tablets also contain opadry II complete film coating system 85F100011 purple. The 9 mg tablets also contain opadry II complete film coating system 85F90637 blue. The 12 mg tablets also contain opadry II complete film coating system 85F170047 beige.
|Pack sizes|| |
|Routes of administration|| |
The dose of Austedo is determined individually for each patient based on reduction of chorea or tardive dyskinesia and tolerability. When first prescribed to patients who are not being switched from tetrabenazine (a related vesicular monoamine transporter type 2 (VMAT2) inhibitor), the recommended starting dose of Austedo is 6 mg administered orally once daily for patients with Huntington’s disease and 12 mg per day (6 mg twice daily) for patients with tardive dyskinesia.
For further information refer to the Product Information.
|Pregnancy category|| |
Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.
The use of any medicine during pregnancy requires careful consideration of both risks and benefits by the treating health professional. This must not be used as the sole basis of decision making in the use of medicines during pregnancy. The TGA does not provide advice on the use of medicines in pregnancy for specific cases. More information is available from obstetric drug information services in your State or Territory.
Austedo (deutetrabenazine) was approved for the following therapeutic use:
Austedo is indicated for the treatment of:
- chorea associated with Huntington's disease
- tardive dyskinesia in adults
The following table summarises the key steps and dates for this application.
|Submission dossier accepted and first round evaluation commenced||30 March 2020|
|First round evaluation completed||1 September 2020|
|Sponsor provides responses on questions raised in first round evaluation||2 November 2020|
|Second round evaluation completed||29 April 2021|
|Delegate's overall benefit-risk assessment and request for Advisory Committee advice||2 March 2021|
|Sponsor's pre-Advisory Committee response||16 March 2021|
|Advisory Committee meeting||8 and 9 April 2021|
|Registration decision (Outcome)||26 May 2021|
|Completion of administrative activities and registration on ARTG||2 June 2021|
|Number of working days from submission dossier acceptance to registration decision*||190|
*Statutory timeframe for standard applications is 255 working days
- Austedo (deutetrabenazine) is to be included in the Black Triangle Scheme. The Product Information and Consumer Medicines Information for Austedo must include the black triangle symbol and mandatory accompanying text for five years, which starts from the date that the sponsor notifies the TGA of supply of the product.
- The deutetrabenazine risk management plan (RMP) (version 1.1, dated 23 October 2020, data lock point 15 September 2020), included with submission PM-2020-00739-1-1, and any subsequent revisions, as agreed with the TGA will be implemented in Australia.
An obligatory component of risk management plans is routine pharmacovigilance. Routine pharmacovigilance includes the submission of periodic safety update reports (PSURs).
Unless agreed separately between the supplier who is the recipient of the approval and the TGA, the first report must be submitted to TGA no later than 15 calendar months after the date of the approval letter. The subsequent reports must be submitted no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter. The annual submission may be made up of two PSURs each covering six months. If the sponsor wishes, the six monthly reports may be submitted separately as they become available.
If the product is approved in the European Union (EU) during the three years period, reports can be provided in line with the published list of EU reference dates no less frequently than annually from the date of the first submitted report until the period covered by such reports is not less than three years from the date of the approval letter.
The reports are to at least meet the requirements for PSURs as described in the European Medicines Agency's Guideline on Good Pharmacovigilance Practices (GVP) Module VII-periodic safety update report (Rev 1), Part VII.B Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report.