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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update, if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.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
| [1] | If the submission is withdrawn prior to the TGA's receipt of the sponsor's response to the Delegate's overview or request for expert advice, then an AusPAR will not be published. |
|---|
Applications under evaluation
Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market
Priority review: involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Provisional registration: involves early access to vital and life-saving medicines through time-limited registration
Displaying 1 - 25 of 62
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)