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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update, if the medicine application has been decided (approved or rejected for registration), or when the applicant has withdrawn the application.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
| [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
Report date: 22 February 2021.
Displaying 1 - 25 of 25
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