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Prescription medicines: applications under evaluation

22 February 2021

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update, if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.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

Report date: 22 February 2021.

Displaying 1 - 25 of 25

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

Accepted for evaluation in February 2021

Application type: C (new indication)

Medicine name: VERZENIO

Applicant name: Eli Lilly Australia Pty Ltd

Active ingredient(s): abemaciclib

Indication:

Adjuvent therapy for breast cancer.

Application type: A (new medicine)

Medicine name: TBA

Applicant name: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): pneumococcal purified capsular polysaccharides

Indication:

For active immunisation for the prevention of pneumococcal disease.

Application type: A (new medicine)

Medicine name: SAPHNELO

Applicant name: AstraZeneca Pty Ltd

Active ingredient(s): anifrolumab

Indication:

For the treatment of systemc lupus erythematosus.

Application type: C (new indication)

Medicine name: RYALTRIS

Applicant name: Seqirus Pty Ltd

Active ingredient(s): mometasone furoate monohydrate; olopatadine hydrochloride

Indication:

For the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis

Application type: A (new medicine)

Medicine name: RUZURGI

Applicant name: ORSPEC Pharma Pty Ltd

Active ingredient(s): amifampridine

Indication:

For the treatment of Lambert-Eaton myasthenic syndrome

Application type: C (new indication)

Medicine name: OPDIVO

Applicant name: Bristol-Myers Squibb Australia Pty Ltd

Active ingredient(s): nivolumab

Indication:

Adjuvent therapy for oesophageal cancer or gastro-oesophageal junction cancer.

Application type: C (new indication)

Medicine name: NUCALA

Applicant name: GlaxoSmithKline Australia Pty Ltd

Active ingredient(s): mepolizumab

Indication:

For the treatment of chronic rhinosinusitis with nasal polyps.

Application type: C (new indication)

Medicine name: NPLATE

Applicant name: Amgen Australia Pty Ltd

Active ingredient(s): romiplostim

Indication:

For the treatment of thrombocytopenia

Application type: C (new indication)

Medicine name: MAVIRET

Applicant name: Abbvie Pty Ltd

Active ingredient(s): glecaprevir; pibrentasvir

Indication:

For the treatment of chronic hepatitis C virus

Application type: A (new medicine)

Medicine name: LUTETIUM (177Lu) CHLORIDE

Applicant name: Australian Nuclear Science and Technology Organisation T/A ANSTO

Active ingredient(s): lutetium (177lu) chloride

Indication:

Radiopharmaceutical precursor

Application type: C (new indication)

Medicine name: LORAZE, LORAZEPAM SXP, LORAZEPAM AJS

Applicant name: Southern XP IP Pty Ltd

Active ingredient(s): lorazepam

Indication:

Pre-operative medication or premedication.

Application type: C (new indication)

Medicine name: KEYTRUDA

Applicant name: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): pembrolizumab

Indication:

For the treatment of oesophageal cancer

Application type: A (new medicine)

Medicine name: JEMPERLI

Applicant name: GlaxoSmithKline Australia Pty Ltd

Active ingredient(s): dostarlimab

Indication:

Therapy for endometrial cancer.

Application type: C (new indication)

Medicine name: JARDIANCE

Applicant name: Boehringer Ingelheim Pty Ltd

Active ingredient(s): empagliflozin

Indication:

For the treatment of heart failure.

Application type: C (new indication)

Medicine name: COSENTYX

Applicant name: Novartis Pharmaceuticals Australia Pty Ltd

Active ingredient(s): secukinumab

Indication:

For the treatment of plaque psoriasis.

Accepted for evaluation in January 2021

Application type: C (new indication)

Medicine name: UTROGESTAN

Applicant name: Besins Healthcare Australia Pty Ltd

Active ingredient(s): progesterone

Indication:

For the prevention of miscarriage

Application type: A (new medicine)

Medicine name: TRUSELTIQ

Applicant name: Adjutor Healthcare Pty Ltd

Active ingredient(s): infigratinib

Indication:

For the second line treatment of cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.

Application type: A (new medicine)

Medicine name: TBA

Applicant name: Pfizer Australia Pty Ltd

Active ingredient(s): somatrogon

Indication:

For treatment of patients with insufficient secretion of growth hormone

Application type: C (new indication)

Medicine name: LIBTAYO

Applicant name: Sanofi-Aventis Australia Pty Ltd

Active ingredient(s): cemiplimab

Indication:

For treatment of non-small cell lung cancer expressing PD-L1

Application type: C (new indication)

Medicine name: KOZENIS

Applicant name: GlaxoSmithKline Australia Pty Ltd

Active ingredient(s): tafenoquine succinate

Indication:

For prevention of relapse of Plasmodium vivax malaria

Application type: A (new medicine)

Medicine name: KERENDIA

Applicant name: Bayer Australia Ltd

Active ingredient(s): finerenone

Indication:

For delayed progression of kidney disease in patients with chronic kidney disease and type 2 diabetes

Application type: C (new indication)

Medicine name: FORXIGA

Applicant name: AstraZeneca Pty Ltd

Active ingredient(s): dapagliflozin (as propanediol monohydrate)

Indication:

For the treatment of chronic kidney disease

Application type: C (new indication)

Medicine name: DENGVAXIA

Applicant name: Sanofi-Aventis Australia Pty Ltd

Active ingredient(s): dengue tetravalent vaccine (live, attenuated)

Indication:

For the prevention of Dengue Disease

Application type: C (new indication)

Medicine name: CYSTADROPS

Applicant name: Recordati Rare Diseases Australia Pty Ltd

Active ingredient(s): mercaptamine (cysteamine)

Indication:

For treatment of patients with cystinosis

Application type: C (new indication)

Medicine name: ACTAIR

Applicant name: Stallergenes Australia Pty Ltd

Active ingredient(s): European house dust mite; American house dust mite

Indication:

For treatment of house dust mite allergy