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Prescription medicines: applications under evaluation

19 April 2022

This page provides a list of applications for new medicines or new uses for existing medicines that are currently under evaluation by the TGA. The list of medicines under evaluation is updated each month.

Information on three types of applications is included:

  • Application type A: applications for a 'new medicine' containing a new active substance (new chemical entity or new biological entity) not currently approved in Australia
  • Application type B: applications for a 'new combination', where two or more already approved medicines are combined into a single product
  • Application type C: applications for a 'new indication', or additional therapeutic use, for an already approved medicine

Applications for new generic and biosimilar medicines are excluded from this list.

The entry for each application includes:

  • the proposed tradename
  • the applicant name
  • the active ingredient(s)
  • a summary of the proposed indication(s)
  • the application type

Publication commenced for applications accepted for evaluation from January 2021. The list only includes medicines that have been accepted for evaluation and are under evaluation with a cut-off the day the report is completed. Entries are removed from the list as part of the monthly update, if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.

You can see if an application has been approved by searching the Australian Register of Therapeutic Goods (ARTG).

Further information about decisions (approved and rejected) and some withdrawals[1] is available in form of an Australian Public Assessment Report (AusPAR) or a Decision summary.

IMPORTANT INFORMATION

Medicines are listed on this page when they are accepted for evaluation by the TGA. It is important to view the information in the context of the following.

Evaluation does not guarantee registration

The list only includes information on medicines that are currently under evaluation for quality, safety and efficacy and are pending the decision to register the medicine on the ARTG.

Not all medicines that are accepted for evaluation are approved by the TGA. Whether a medicine is approved or not depends on the outcomes of our assessment of the application.

The medicine's indications can also change following our evaluation of the data. For more information visit our web page on new registrations.

Evaluation does not guarantee PBS listing

While entry on the ARTG provides for legal supply of a medicine in Australia, the listing of the medicine on the Pharmaceutical Benefits Scheme (PBS) facilitates subsidised access to medicines. PBS listing is subject to a separate application process that is also initiated by the company and typically follows the registration on the ARTG. For information about PBS listings visit the PBS website.

Each year the TGA accepts approximately 100 major innovator applications for new medicines or new uses of medicines.


Footnotes


Applications under evaluation


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


Displaying 51 - 75 of 135

Enter medicine name, applicant name, indication, or active ingredient

Accepted for evaluation in September 2021

provisional registration
Application type: C (new indication)
Medicine name: LIBTAYO
Applicant: Sanofi-Aventis Australia Pty Ltd
Active ingredient(s): cemiplimab
Proposed Indication: For treatment of metastatic basal cell carcinoma
priority review
Application type: C (new indication)
Medicine name: LIBTAYO
Applicant: Sanofi-Aventis Australia Pty Ltd
Active ingredient(s): cemiplimab
Proposed Indication: For treatment of metastatic cervical cancer
provisional registration orphan drug
Application type: C (new indication)
Medicine name: IMFINZI
Applicant: AstraZeneca Pty Ltd
Active ingredient(s): durvalumab
Proposed Indication: For treatment of unresectable Malignant Pleural Mesothelioma
orphan drug
Application type: A (new medicine)
Medicine name: ERWINASE
Applicant: PPD Australia Pty Ltd
Active ingredient(s): crisantaspase (L-asparaginase from Erwinia chrysantemi)
Proposed Indication: For treatment of acute lymphoblastic leukaemia
Application type: A (new medicine)
Medicine name: CAMZYOS
Applicant: Bristol-Myers Squibb Australia Pty Ltd
Active ingredient(s): mavacamten
Proposed Indication: For treatment of symptomatic obstructive hypertrophic cardiomyopathy
Application type: C (new indication)
Medicine name: BEOVU; VSIQQ
Applicant: Novartis Pharmaceuticals Australia Pty Ltd
Active ingredient(s): brolucizumab (rbe)
Proposed Indication: For treatment of diabetic macular oedema
Application type: C (new indication)
Medicine name: BENLYSTA
Applicant: GlaxoSmithKline Australia Pty Ltd
Active ingredient(s): belimumab
Proposed Indication: For treatment of lupus nephritis

Accepted for evaluation in August 2021

Application type: A (new medicine)
Medicine name: VABYSMO
Applicant: Roche Products Pty Ltd
Active ingredient(s): faricimab
Proposed Indication: For treatment of neovascular age-related macular degeneration and diabetic macular oedema.
orphan drug
Application type: C (new indication)
Medicine name: TRIKAFTA
Applicant: Vertex Pharmaceuticals Australia Pty Ltd
Active ingredient(s): elexacaftor; ivacaftor; tezacaftor
Proposed Indication: For treatment of patients who have mutation in the cystic fibrosis transmembrane conductance regulator gene.
orphan drug
Application type: A (new medicine)
Medicine name: TRECONDI
Applicant: Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Active ingredient(s): treosulfan
Proposed Indication: For conditioning treatment prior to allogeneic hematopoietic stem cell transplantation.
provisional registration orphan drug
Application type: A (new medicine)
Medicine name: TEPMETKO
Applicant: Merck Healthcare Pty Ltd
Active ingredient(s): tepotinib hydrochloride monohydrate
Proposed Indication: For treatment of advanced non-small cell lung cancer.
orphan drug
Application type: C (new indication)
Medicine name: TEPADINA
Applicant: Link Medical Products Pty Ltd T/A Link Pharmaceuticals
Active ingredient(s): thiotepa
Proposed Indication: For conditioning treatment prior to allogeneic or autologous haematopoietic progenitor cell transplantation (HPCT) in haematological diseases.
Application type: C (new indication)
Medicine name: TECENTRIQ
Applicant: Roche Products Pty Ltd
Active ingredient(s): atezolizumab
Proposed Indication: For adjuvant treatment of early-stage non-small cell lung cancer.
provisional registration
Application type: A (new medicine)
Medicine name: TBA
Applicant: Merck Sharp & Dohme (Australia) Pty Ltd
Active ingredient(s): molnupiravir
Proposed Indication: For treatment of COVID-19.
Application type: A (new medicine)
Medicine name: SPY AGENT GREEN
Applicant: Stryker Australia Pty Ltd
Active ingredient(s): indocyanine green
Proposed Indication: For visualisation and fluorescence imaging of vessel and tissue.
Application type: A (new medicine)
Medicine name: SCEMBLIX
Applicant: Novartis Pharmaceuticals Australia Pty Ltd
Active ingredient(s): asciminib hydrochloride
Proposed Indication: For treatment of Philadelphia chromosomepositive chronic myeloid leukaemia in chronic phase.
provisional registration
Application type: A (new medicine)
Medicine name: RONAPREVE
Applicant: Roche Products Pty Ltd
Active ingredient(s): casirivimab; imdevimab
Proposed Indication: For treatment of COVID-19.
Application type: C (new indication)
Medicine name: OPDIVO
Applicant: Bristol-Myers Squibb Australia Pty Ltd
Active ingredient(s): nivolumab
Proposed Indication: For adjuvant treatment of patients with muscle invasive urothelial carcinoma (MIUC).
Application type: C (new indication)
Medicine name: ONUREG
Applicant: Celgene Pty Ltd
Active ingredient(s): azacitidine
Proposed Indication: For maintenance treatment of acute myeloid leukaemia.
Application type: C (new indication)
Medicine name: LIPIODOL ULTRA FLUID
Applicant: Guerbet Australia Pty Ltd
Active ingredient(s): iodised oil
Proposed Indication: For treatment of hysterosalpingography.
Application type: A (new medicine)
Medicine name: LETYBO
Applicant: CROMA Australia Pty Ltd
Active ingredient(s): letibotulinumtoxin A
Proposed Indication: For treatment of glabellar frown lines.
Application type: C (new indication)
Medicine name: KYPROLIS
Applicant: Amgen Australia Pty Ltd
Active ingredient(s): carfilzomib
Proposed Indication: For the treatment of relapsed or refractory multiple myeloma in combination with daratumumab and dexamethasone.
orphan drug
Application type: A (new medicine)
Medicine name: ISTURISA
Applicant: Recordati Rare Diseases Australia Pty Ltd
Active ingredient(s): osilodrostat phosphate
Proposed Indication: For treatment of endogenous Cushing's syndrome.
provisional registration
Application type: A (new medicine)
Medicine name: EXKIVITY
Applicant: Takeda Pharmaceuticals Australia Pty Ltd
Active ingredient(s): mobocertinib
Proposed Indication: For treatment of patients with epidermal growth factor receptor (EGFR) exon 20 insertion mutation non-small cell lung cancer.
Application type: C (new indication)
Medicine name: COSENTYX
Applicant: Novartis Pharmaceuticals Australia Pty Ltd
Active ingredient(s): secukinumab
Proposed Indication: For treatment of enthesitis-related arthritis and juvenile psoriatic arthritis.

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