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Prescription medicines: new or extended uses, or new combinations of registered medicines

15 May 2019

Over time, the approved therapeutic uses of prescription medicines registered on the Australian Register of Therapeutic Goods (ARTG) can change.

Changes commonly include 'new uses' or 'extended uses'. A new use is where an already registered medicine is approved for an additional therapeutic use. An extended use is where an already registered medicine is approved to treat a broader range of patients, e.g. a wider age range. New or extended uses are called 'extensions of indications'. By contrast, a 'new combination' is where two or more already registered medicines are combined into a single product.

The decision to approve an 'extension of indications' or 'new combination' for already registered prescription medicines follows a comprehensive review by TGA scientists and clinicians on the quality, safety and efficacy of the proposed use of the medicine.

Throughout the year, we will be publishing information relating to new or extended uses, or new combinations of registered prescription medicines on the TGA website.

The trade name, active ingredient, and sponsor for each medicine reflects the information entered into the ARTG when the new or extended use was first approved. This webpage provides a summary of the newly added indications; for a full list of each medicine's registered indications, please refer to the Product Information database.

Once an application has been accepted for evaluation by TGA, the approval time is defined as the number of TGA working days between commencement of evaluation and registration decision. TGA works to business target timeframes as well as to legislated timeframes for each category of application. Approval times are underpinned by legislation (see Therapeutic Goods Regulations 1990) and excludes public holidays, weekends, the time allocated to the sponsor to respond to requests for information, 'mutual clock stop' periods agreed with the sponsor, or other review activities.

Approval times are reported in the number of TGA working days for each new registration, along with the legislated timeframe (unless otherwise indicated) for that category of application in brackets.


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


Registration of new or extended uses of registered medicines, 2019

Previous years

2018 2017 2016

April 2019

TECENTRIQ

Evaluation commenced: 30 Apr 2018

Registration decision: 12 Apr 2019

Date registered: 26 Apr 2019

Approval time: 196 working days (255)

atezolizumab

Roche Products Pty Ltd

Non-small cell lung cancer

TECENTRIQ, in combination with bevacizumab, paclitaxel and carboplatin, is now also indicated for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer (NSCLC). In patients with EGFR mutant or ALK-positive NSCLC, TECENTRIQ, in combination with bevacizumab, paclitaxel and carboplatin, is indicated only after failure of appropriate targeted therapies.

TECENTRIQ as monotherapy is now also indicated for the treatment of adult patients with locally advanced or metastatic NSCLC after prior chemotherapy. Patients with EGFR mutant or ALK-positive NSCLC should also have received targeted therapies before receiving Tecentriq.

TECENTRIQ

Evaluation commenced: 4 Apr 2018

Registration decision: 12 Apr 2019

Date registered: 24 Apr 2019

Approval time: 217 working days (255)

atezolizumab

Roche Products Pty Ltd

Urothelial carcinoma

TECENTRIQ is now also indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who

  • are considered cisplatin ineligible and whose tumours express PD-L1 (PD-L1 stained tumour-infiltrating immune cells [IC] covering ≥ 5% of the tumour area), as determined by a validated test, or
  • are considered ineligible for any other platinum-containing chemotherapy regardless of the level of tumor PD-L1 expression.

ARIXTRA

Evaluation commenced: 30 Nov 2017

Registration decision: 9 Apr 2019

Date registered: 12 Apr 2019

Approval time: 237 working days (255)

fondaparinux sodium

Aspen Pharmacare Australia Pty Ltd

ARIXTRA is now also indicated for the treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (<120 min) invasive management (PCI) in not indicated.

ARIXTRA is now also indicated for the treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed without any form of initial reperfusion therapy.

March 2019

INOmax

Evaluation commenced: 30 Apr 2018

Registration decision: 25 Mar 2019

Date registered: 29 Mar 2019

Approval time: 208 working days (255)

nitric oxide

Ikaria Australia Pty Ltd

INOmax (medicinal gas for inhalation) in conjunction with ventilatory support and other appropriate agents, is now also indicated to selectively decrease pulmonary arterial pressure in patients with perioperative pulmonary hypertension in conjunction with heart surgery.

ACTEMRA

Evaluation commenced: 31 Jan 2019

Registration decision: 22 Mar 2019

Date registered: 28 Mar 2019

Approval time: 36 working days (120 COR-A)

tocilizumab

Roche Products Pty Ltd

ACTEMRA (solution for injection) is now also indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older (IV formulation only).

AFLURIA QUAD, AFLURIA QUAD JUNIOR

Evaluation commenced: 2 Jan 2018

Registration decision: 15 Mar 2019

Date registered: 18 Mar 2019

Approval time: 197 working days (255)

influenza virus haemagglutinin

Seqirus Pty Ltd

For the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine. Afluria Quad vaccine (suspension for injection) is indicated for use in persons aged 3 years and older. Afluria Quad Junior vaccine (suspension for injection) is indicated for use in children aged 6 months to 35 months inclusive. For full details regarding recommendations for influenza vaccination, please refer to the relevant national immunisation guidelines.

ARNUITY ELLIPTA

Evaluation commenced: 3 Apr 2018

Registration decision: 8 Mar 2019

Date registered: 14 Mar 2019

Approval time: 200 working days (255)

fluticasone furoate

GlaxoSmithKline Australia Pty Ltd

ARNUITY ELLIPTA (powder for inhalation) is now also indicated for the maintenance treatment of asthma in patients aged 5 years to less than 12 years.

KEYTRUDA priority review

Evaluation commenced: 6 Sep 2018

Registration decision: 5 Mar 2019

Date registered: 8 Mar 2019

Approval time: 124 working days (255)

pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

KEYTRUDA (powder for injection), in combination with carboplatin and either paclitaxel or nab-paclitaxel, is now also indicated for the first-line treatment of patients with metastatic squamous NSCLC.

REVOLADE priority review

Evaluation commenced: 1 Nov 2018

Registration decision: 7 Mar 2019

Date registered: 8 Mar 2019

Approval time: 87 working days (255)

eltrombopag olamine

Novartis Pharmaceuticals Australia Pty Ltd

REVOLADE (film-coated tablet and powder for oral suspension) is now also indicated for the treatment of adult and paediatric patients 2 years and older with severe aplastic anaemia (SAA) for use in combination with standard immunosuppressive therapy (first-line SAA).

February 2019

ZAVICEFTA

Evaluation commenced: 30 Apr 2018

Registration decision: 21 Feb 2019

Date registered: 22 Feb 2019

Approval time: 161 working days (175 COR-B)

avibactam sodium; ceftazidime pentahydrate

Pfizer Australia Pty Ltd

New combination

ZAVICEFTA (powder for injection) is indicated for the treatment of the following infections in adults:

  • Complicated intra-abdominal infection (cIAI), in combination with metronidazole.
  • Complicated urinary tract infection (cUTI), including pyelonephritis.
  • Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP).

Consideration should be given to official guidance on the appropriate use of antibacterial agents. ZAVICEFTA should be used in combination with an antibacterial agent(s) active against Gram-positive and/or anaerobic pathogens when these are known or suspected to be contributing to the infectious process.

XELJANZ

Evaluation commenced: 31 Jan 2018

Registration decision: 29 Jan 2019

Date registered: 19 Feb 2019

Approval time: 195 working days (255)

tofacitinib citrate

Pfizer Australia Pty Ltd

XELJANZ (film coated tablets) is now also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biological therapy.

KAPANOL

Evaluation commenced: 1 Aug 2017

Registration decision: 6 Feb 2019

Date registered: 14 Feb 2019

Approval time: 218 working days (255)

morphine sulfate pentahydrate

Mayne Pharma International Pty Ltd

KAPANOL (modified release capsules) is indicated for the symptomatic reduction of chronic breathlessness in the palliative care of patients with distressing breathlessness due to severe COPD, cardiac failure, malignancy or other cause. Kapanol should only be used after treatments for the underlying cause(s) of the breathlessness have been optimised and non-pharmacological treatments are not effective. Treatment with Kapanol in this setting should only be initiated by a specialist knowledgeable in its use.

DELSTRIGO

Evaluation commenced: 31 Jan 2018

Registration decision: 18 Jan 2019

Date registered: 4 Feb 2019

Approval time: 192 working days (255)

tenofovir disoproxil fumarate; lamivudine; doravirine

Merck Sharp & Dohme (Australia) Pty Ltd

New combination

DELSTRIGO is indicated for the treatment of HIV-1 infection in adults who are antiretroviral therapy (ART)-naÏve with no known substitutions associated with resistance to doravirine, lamivudine, or tenofovir.

EZETIMIBE LUPIN, EZETIMIBE LAPL, EZETIMIBE GH

Evaluation commenced: 28 Nov 2018

Registration decision: 25 Jan 2019

Date registered: 4 Feb 2019

Approval time: 40 working days (255)

ezetimibe

Lupin Australia Pty Limited

Generic medicine

EZETIMIBE LUPIN, EZETIMIBE LAPL and EZETIMIBE GH (tablets), in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit, is now also indicated for the prevention of cardiovascular disease in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) in need of additional lowering of LDL-C in the expectation of a modest further reduction in the risk of cardiovascular events following at least one year of therapy.

January 2019

NUCALA orphan drug

Evaluation commenced: 2 Jan 2018

Registration decision: 24 Jan 2019

Date registered: 29 Jan 2019

Approval time: 224 working days (255)

mepolizumab

GlaxoSmithKline Australia Pty Ltd

NUCALA is now also indicated as an add-on treatment for relapsing or refractory Eosinophilic Granulomatosis with Polyangiitis (EGPA) in adult patients aged 18 years and over.

CUBICIN

Evaluation commenced: 31 Jan 2018

Registration decision: 22 Jan 2019

Date registered: 25 Jan 2019

Approval time: 200 working days (255)

daptomycin

Merck Sharp & Dohme (Australia) Pty Ltd

CUBICIN (powder for injection) is now also indicated for:

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

CUBICIN is indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.

XARELTO

Evaluation commenced: 31 Jan 2018

Registration decision: 24 Dec 2018

Date registered: 11 Jan 2019

Approval time: 184 working days (255)

rivaroxaban

Bayer Australia Ltd

XARELTO (tablets), in combination with aspirin, is now also indicated for the prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD).

CIZIGO , CIZINATE, CIZERE

Evaluation commenced: 31 May 2017

Registration decision: 24 Dec 2018

Date registered: 8 Jan 2019

Approval time: 246 working days (255)

cinnarizine/dimenhydrinate

Southern Cross Pharma Pty Ltd

New combination

CIZIGO, CIZINATE, CIZERE (fixed-dose combination tablets) are indicated for the short-term, symptomatic treatment of vertigo of various causes, in adults who have not responded to alternative treatments.