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Prescription medicines: applications under evaluation

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if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.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


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 1 - 25 of 62

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

Accepted for evaluation in June 2021

Application type: B (new combination)

Medicine name: VYXEOS

Applicant: Jazz Pharmaceuticals ANZ Pty Ltd

Active ingredient(s): cytarabine; daunorubicin hydrochloride

Indication:

For treatmnet of acute myeloid leukaemia

Application type: C (new indication)

Medicine name: VALDOXAN

Applicant: Servier Laboratories Australia Pty Ltd

Active ingredient(s): agomelatine

Indication:

For treatment of mental health conditions.

Application type: C (new indication)

Medicine name: ULTOMIRIS

Applicant: Alexion Pharmaceuticals Australasia Pty Ltd

Active ingredient(s): ravulizumab

Indication:

For treatment of atypical haemolytic uraemic syndrome.

Application type: C (new indication)

Medicine name: TRIMBOW

Applicant: Chiesi Australia Pty Ltd

Active ingredient(s): beclometasone dipropionate; formoterol (eformoterol) fumarate dihydrate; glycopyrronium bromide (glycopyrrolate)

Indication:

For treatment of respiratory conditions.

Application type: C (new indication)

Medicine name: THIOTEPA

Applicant: Reach Pharmaceuticals Pty Ltd

Active ingredient(s): ethanol; thiotepa; water for injections

Indication:

As conditioning treatment prior to haematopoietic progenitor cell transplantation.

Application type: A (new medicine)

Medicine name: TBA

Applicant: Maxx Pharma Pty Ltd

Active ingredient(s): diphtheria toxoid; haemophilus influenza type b polyribose ribitol phosphate; pertactin; pertussis filamentous haemagglutinin; pertussis fimbriae 2 + 3; pertussis toxoid; poliovirus; tetanus toxoid; hepatitis b surface antigen

Indication:

For prevention of several infectious diseases in infants and toddlers.

Application type: A (new medicine)

Medicine name: SOGROYA

Applicant: Novo Nordisk Pharmaceuticals Pty Ltd

Active ingredient(s): somapacitan

Indication:

For treatment of growth hormone deficiency.

Application type: C (new indication)

Medicine name: SHINGRIX

Applicant: GlaxoSmithKline Australia Pty Ltd

Active ingredient(s): recombinant varicella zoster virus glycoprotein e antigen

Indication:

For prevention of herpes zoster and post-herpetic neuralgia.

Application type: C (new indication)

Medicine name: LENVIMA

Applicant: Eisai Australia Pty Ltd

Active ingredient(s): lenvatinib mesilate

Indication:

For treatment of renal cell carcinoma.

Application type: C (new indication)

Medicine name: KEYTRUDA

Applicant: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): pembrolizumab

Indication:

For treatment of renal cell carcinoma.

Application type: C (new indication)

Medicine name: KEYTRUDA

Applicant: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): pembrolizumab

Indication:

For treatment of cutaneous squamous cell carcinoma.

Application type: C (new indication)

Medicine name: INOMAX

Applicant: Ikaria Australia Pty Ltd

Active ingredient(s): nitric oxide

Indication:

For treatment of respiratory condition.

Application type: C (new indication)

Medicine name: GARDASIL 9

Applicant: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): hpv type 11 l1 protein; hpv type 16 l1 protein; hpv type 18 l1 protein; hpv type 31 l1 protein; hpv type 33 l1 protein; hpv type 45 l1 protein; hpv type 52 l1 protein; hpv type 58 l1 protein; hpv type 6 l1 protein

Indication:

To prevent infection against human papillomavirus types 6, 11, 16, 18, 31, 33, 45, 52 and 58.

Application type: C (new indication)

Medicine name: Fluzone High-Dose Quadrivalent

Applicant: Sanofi-Aventis Australia Pty Ltd

Active ingredient(s): influenza virus haemagglutinin

Indication:

For prevention of influenza disease.

Application type: C (new indication)

Medicine name: DUPIXENT

Applicant: Sanofi-Aventis Australia Pty Ltd

Active ingredient(s): dupilumab

Indication:

For treatment of asthma.

Application type: C (new indication)

Medicine name: COMIRNATY

Applicant: Pfizer Australia Pty Ltd

Active ingredient(s): bnt162b2 (mrna)

Indication:

For prevention of coronavirus disease 2019.

Application type: B (new combination)

Medicine name: BIJUVA

Applicant: Theramex Australia Pty Ltd

Active ingredient(s): estradiol hemihydrate; progesterone

Indication:

For treatment of hormones deficiency.

Application type: A (new medicine)

Medicine name: BAQSIMI

Applicant: Eli Lilly Australia Pty Ltd

Active ingredient(s): glucagon

Indication:

For treatment of severe hypoglycaemia.

Accepted for evaluation in May 2021

Application type: A (new medicine)

Medicine name: XEVUDY

Applicant: GlaxoSmithKline Australia Pty Ltd

Active ingredient(s):

Indication:

For treatment of coronavirus disease 2019.

Accepted for evaluation in April 2021

Application type: C (new indication)

Medicine name: VELTASSA

Applicant: Vifor Pharma Pty Ltd

Active ingredient(s): patiromer sorbitex calcium

Indication:

For use in renin-angiotensin-aldosterone system inhibitor therapy

Application type: C (new indication)

Medicine name: STEGLUJAN/ MSD

Applicant: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): ertugliflozin pyroglutamic acid; sitagliptin phosphate monohydrate

Indication:

To reduce hospitalisation due to heart failure

Application type: C (new indication)

Medicine name: STEGLATRO / MSD

Applicant: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): ertugliflozin pyroglutamic acid

Indication:

To reduce hospitalisation due to heart failure

Application type: C (new indication)

Medicine name: SKYRIZI

Applicant: Abbvie Pty Ltd

Active ingredient(s): risankizumab

Indication:

For treatment of psoriatic arthritis

Application type: C (new indication)

Medicine name: SEGLUROMET / MSD

Applicant: Merck Sharp & Dohme (Australia) Pty Ltd

Active ingredient(s): ertugliflozin pyroglutamic acid; metformin hydrochloride

Indication:

To reduce hospitalisation due to heart failure

Application type: A (new medicine)

Medicine name: PADCEV

Applicant: Astellas Pharma Australia Pty Ltd

Active ingredient(s): enfortumab vedotin

Indication:

For the treatment of adult patients with locally advanced (LA) or metastatic urothelial cancer (mUC)

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