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Prescription medicines: registration of new chemical entities in Australia

19 August 2021

Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical Entities (NCEs) or New Biological Entities (NBEs).

Some of these NCEs/NBEs are innovative or 'first-in-class', and have been made available to the public for the first time outside the controlled environment of a clinical trial.

This decision by TGA to register a NCE/NBE often comes after years of research and development and following a comprehensive review by TGA scientists and clinicians of the medicine's quality, safety and efficacy.

Throughout the year, we will be publishing information on the new prescription medicines as they are approved. However, it may still be some time before the sponsor (pharmaceutical company) decides to supply the product in Australia.

The trade name, active ingredient, and sponsor for each new prescription medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG).

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

Approval times are reported in the number of TGA working days for each new registration, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.


symbol denoting an orphan drug

Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market

symbol denoting a priority determination

Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available

symbol denoting a provisional registration

Provisional registration: involves early access to vital and life-saving medicines through time-limited registration


Registration of NCEs, 2021

Previous years

2020 2019 2018 2017 2016 2015 2014

July 2021

DAYVIGO

Evaluation commenced: 30 Jun 2020

Registration decision: 15 Jul 2021

Date registered: 16 Jul 2021

Approval time: 224 (255 working days)

lemborexant

Eisai Australia Pty Ltd

DAYVIGO (film coated tablet) is indicated for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance in accordance with latest DSM criteria.

PALYNZIQ orphan drug

Evaluation commenced: 30 Sep 2020

Registration decision: 6 Jul 2021

Date registered: 14 Jul 2021

Approval time: 166 (175 working days)

pegvaliase

BioMarin Pharmaceutical Australia Pty Ltd

PALYNZIQ (solution for injection, pre-filled syringe) is indicated for the treatment of patients with phenylketonuria (PKU) aged 16 years and older who have inadequate blood phenylalanine control despite prior management with available treatment options.

RUKOBIA

Evaluation commenced: 31 Jul 2020

Registration decision: 9 Jul 2021

Date registered: 14 Jul 2021

Approval time: 191 (255 working days)

fostemsavir trometamol

ViiV Healthcare Pty Ltd

RUKOBIA (extended release tablet) is indicated in combination with other antiretroviral agents for the treatment of heavily treatment-experienced adults with multidrug-resistant human immunodeficiency virus-1 (HIV-1) infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen due to resistance, intolerance or safety considerations (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials).

June 2021

COVID-19 VACCINE JANSSEN provisional registration

Evaluation commenced: 1 Dec 2020

Registration decision: 25 Jun 2021

Date registered: 25 Jun 2021

Approval time: 136 (255 working days)

ad26.cov2.s

Janssen-Cilag Pty Ltd

COVID-19 Vaccine Janssen (suspension for injection) has provisional approval for the indication:

COVID-19 Vaccine Janssen is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

LEDAGA orphan drug

Evaluation commenced: 31 Jul 2020

Registration decision: 8 Jun 2021

Date registered: 22 Jun 2021

Approval time: 170 (255 working days)

chlormethine hydrochloride

Recordati Rare Diseases Australia Pty Ltd

LEDAGA (gel) is indicated for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.

VYEPTI

Evaluation commenced: 2 Jun 2020

Registration decision: 9 Jun 2021

Date registered: 16 Jun 2021

Approval time: 213 (255 working days)

eptinezumab

Lundbeck Australia Pty Ltd

VYEPTI (concentrated injection for dilution for infusion) is indicated for the preventive treatment of migraine in adults.

AUSTEDO

Evaluation commenced: 30 Mar 2020

Registration decision: 26 May 2021

Date registered: 2 Jun 2021

Approval time: 190 (255 working days)

deutetrabenazine

Teva Pharma Australia Pty Ltd

AUSTEDO (modified release tablet) is indicated for the treatment of:

  • chorea associated with Huntington's disease
  • tardive dyskinesia in adults

EVRYSDI orphan drugpriority review

Evaluation commenced: 31 Aug 2020

Registration decision: 2 Jun 2021

Date registered: 2 Jun 2021

Approval time: 145 (255 working days)

risdiplam

Roche Products Pty Ltd

EVRYSDI (powder for oral solution) is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients aged 2 months and older.

May 2021

ZEBINIX

Evaluation commenced: 2 Jun 2020

Registration decision: 10 May 2021

Date registered: 18 May 2021

Approval time: 196 (255 working days)

eslicarbazepine acetate

Maxx Pharma Pty Ltd

ZEBINIX (tablet) is indicated as:

  • monotherapy in the treatment of partial-onset seizures, with or without secondary generalisation, in adults with newly diagnosed epilepsy;
  • adjunctive therapy in adults, adolescents and children aged above 6 years, with partial-onset seizures with or without secondary generalisation.

CUTAQUIG

Evaluation commenced: 30 Apr 2020

Registration decision: 21 Apr 2021

Date registered: 3 May 2021

Approval time: 199 (255 working days)

human immunoglobulin g

Octapharma Australia Pty Ltd

CUTAQUIG (solution for injection) is indicated for replacement therapy in adults and children in:

  • Primary immunodeficiency diseases (PID)
  • Symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment.

April 2021

YONDELIS orphan drug

Evaluation commenced: 30 Apr 2020

Registration decision: 21 Apr 2021

Date registered: 22 Apr 2021

Approval time: 193 (255 working days)

trabectedin

Specialised Therapeutics Pharma Pty Ltd

YONDELIS (powder for injection) is indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.

ADAKVEO orphan drug

Evaluation commenced: 31 Jan 2020

Registration decision: 6 Apr 2021

Date registered: 8 Apr 2021

Approval time: 215 (255 working days)

crizanlizumab

Novartis Pharmaceuticals Australia Pty Ltd

ADAKVEO (concentrate solution for infusion) is indicated for the prevention of recurrent vaso-occlusive crises in patients aged 16 years and older with sickle cell disease.

March 2021

TRIENTINE DR.REDDY'S, TRIENTINE-DRLA, TRIENTINE-REDDY'S, TRIENTINE-RZ orphan drug

Evaluation commenced: 31 Mar 2020

Registration decision: 15 Feb 2021

Date registered: 29 Mar 2021

Approval time: 160 (255 working days)

trientine dihydrochloride

Dr Reddys Laboratories Australia Pty Ltd

TRIENTINE DR.REDDY'S, TRIENTINE-DRLA, TRIENTINE-REDDY'S, TRIENTINE-RZ (capsule) are indicated for the treatment of patients with Wilson's disease who are intolerant of penicillamine.

TRIKAFTA orphan drug

Evaluation commenced: 31 Mar 2020

Registration decision: 17 Mar 2021

Date registered: 24 Mar 2021

Approval time: 218 (255 working days)

elexacaftor; ivacaftor; tezacaftor

Vertex Pharmaceuticals Australia Pty Ltd

TRIKAFTA (tablet) is indicated for the treatment of cystic fibrosis (CF) in patients aged 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

OVALEAP

Evaluation commenced: 31 Jan 2020

Registration decision: 9 Mar 2021

Date registered: 10 Mar 2021

Approval time: 187 (255 working days)

follitropin alfa

Theramex Australia Pty Ltd

OVALEAP (solution for injection) is indicated for:

  1. The treatment of anovulatory infertility in women who have been unresponsive to clomiphene citrate or where clomiphene citrate is contraindicated.
  2. For controlled ovarian hyperstimulation in women undergoing assisted reproductive technologies.
  3. OVALEAP is indicated with concomitant human chorionic gonadotrophin (hCG) therapy for the stimulation of spermatogenesis in gonadotrophin-deficient men in whom hCG alone is ineffective.

SPRAVATO

Evaluation commenced: 2 Jan 2019

Registration decision: 5 Mar 2021

Date registered: 9 Mar 2021

Approval time: 305 (255 working days)

esketamine hydrochloride

Janssen-Cilag Pty Ltd

SPRAVATO (nasal spray) is indicated for treatment resistant depression (Major Depressive Disorder in adults who have not responded adequately to at least two different antidepressants of adequate dose and duration to treat the current moderate to severe depressive episode).

SPRAVATO is to be initiated in conjunction with a newly initiated oral antidepressant.

ZOLGENSMA orphan drug

Evaluation commenced: 29 Jan 2020

Registration decision: 24 Feb 2021

Date registered: 4 Mar 2021

Approval time: 199 (255 working days)

onasemnogene abeparvovec

Novartis Pharmaceuticals Australia Pty Ltd

ZOLGENSMA (injection for intravenous infusion) (onasemnogene abeparvovec) is indicated for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.

RUXIENCE

Evaluation commenced: 6 Apr 2020

Registration decision: 26 Feb 2021

Date registered: 3 Mar 2021

Approval time: 188 (255 working days)

rituximab

Pfizer Australia Pty Ltd

Non-Hodgkin's Lymphoma

RUXIENCE (concentrated solution for injection) is indicated for treatment of patients with:

  • CD20 positive, previously untreated, Stage III/IV follicular, B-cell non-Hodgkin's lymphoma,
  • CD20 positive, relapsed or refractory low grade or follicular, B-cell non-Hodgkin's lymphoma,
  • CD20 positive, diffuse large B-cell non-Hodgkin's lymphoma, in combination with chemotherapy.
Chronic Lymphocytic Leukaemia

RUXIENCE is indicated for the treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.

Rheumatoid Arthritis

RUXIENCE in combination with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF) inhibitor therapy.

RUXIENCE has been shown to reduce the rate of progression of joint damage as measured by x-ray when given in combination with methotrexate.

Granulomatosis with polyangiitis (Wegener's) (GPA) and Microscopic polyangiitis (MPA)

RUXIENCE in combination with glucocorticoids is indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) and Microscopic polyangiitis (MPA). The efficacy and safety of retreatment with RUXIENCE have not been established.

February 2021

COVID-19 VACCINE ASTRAZENECA provisional registration

Evaluation commenced: 1 Dec 2020

Registration decision: 15 Feb 2021

Date registered: 16 Feb 2021

Approval time: 48 (255 working days)

chadox1-s

AstraZeneca Pty Ltd

COVID-19 VACCINE ASTRAZENECA (solution for injection) has provisional approval for the indication:

  • Active immunisation of individuals ≥ 18 years old for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.

The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short term efficacy and safety data. Continued approval is dependent upon the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.

VOCABRIA

Evaluation commenced: 31 Oct 2019

Registration decision: 10 Feb 2021

Date registered: 16 Feb 2021

Approval time: 253 (255 workign days)

cabotegravir

ViiV Healthcare Pty Ltd

VOCABRIA (tablet) are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine (see sections 4.2 DOSE AND METHOD OF ADMINISTRATION and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials) for:

  • oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection.
  • oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.

POTELIGEO orphan drug

Evaluation commenced: 1 Apr 2020

Registration decision: 6 Jan 2021

Date registered: 5 Feb 2021

Approval time: 167 (175 working days)

mogamulizumab

Kyowa Kirin Australia Pty Ltd

POTELIGEO (concentrate for solution for infusion) is indicated for the treatment of adult patients (≥18 years of age) with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.

January 2021

COMIRNATY COVID-19 VACCINE provisional registration

Evaluation commenced: 2 Nov 2020

Registration decision: 25 Jan 2021

Date registered: 25 Jan 2021

Approval time: 55 (255 working days)

bnt162b2 (mrna)

Pfizer Australia Pty Ltd

COMIRNATY (BNT162b2[mRNA]) COVID-19 Vaccine (concentrated suspension for injection) has provisional approval for the indication below:

  • Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2, in individuals 16 years of age and older.
  • The use of this vaccine should be in accordance with official recommendations.

The decision has been made on the basis of short term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.

AKLIEF

Evaluation commenced: 30 Apr 2020

Registration decision: 11 Jan 2021

Date registered: 18 Jan 2021

Approval time: 166 (175 working days)

trifarotene

Galderma Australia Pty Ltd

AKLIEF (cream) is indicated for the topical treatment of Acne Vulgaris of the face and/or the trunk in patients from 12 years of age and older, when many comedones, papules and/or pustules are present.

TRIENTINE WAYMADE orphan drug

Evaluation commenced: 30 Jan 2020

Registration decision: 7 Jan 2021

Date registered: 11 Jan 2021

Approval time: 188 (255 working days)

trientine dihydrochloride

Waymade Australia Pty Limited

TRIENTINE WAYMADE (capsule) is indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine.