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Each year, approximately 40 new prescription medicines containing new active substances are registered. These are called New Chemical Entities (NCEs) by the TGA.
Some of these NCEs are innovative or 'first-in-class', and have been made available for the first time outside the controlled environment of a clinical trial.
This decision by the TGA often comes after years of research and development and following a comprehensive review by the TGA scientists and clinicians of the quality, safety and efficacy of the new prescription medicines.
Throughout the year we will be publishing information on the new prescription medicines when they are approved. However, it may still be some time before the pharmaceutical company decides to supply the product in Australia.
The trade name, sponsor and active ingredient for each medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG).
2017 summary
The Prescription medicines and biologicals: TGA annual summary 2017 publication provides details of all NCEs registered in 2017, as well as new or extended uses for existing medicines, priority determinations and orphan drug designations, biologicals, generic prescription medicines, biosimilar prescription medicines and Australian Public Assessment Reports (AusPARs).
Registration of NCEs, 2017
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. This timeframe is 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.
All products were approved within the statutory 255 working day period.
Orphan drug: sponsors receive a fee waiver to help bring medicines for a small population to market
2017: Dec Nov Oct Sep Aug Jul May Apr Mar Feb Jan
December 2017
FLUZONE HIGH-DOSE
Evaluation commenced: 31 March 2017
Registration decision: 20 December 2017
Entry onto ARTG: 21 December 2017
Approval time: 162 working days
inactivated trivalent influenza vaccine (Split Virion)
Sanofi-Aventis Australia Pty Ltd
Fluzone High-Dose is indicated for active immunisation against influenza disease caused by influenza virus types A and B contained in the vaccine for use in persons 65 years of age and older.
VELTASSA
Evaluation commenced: 31 October 2016
Registration decision: 5 December 2017
Entry onto ARTG: 12 December 2017
Approval time: 231 working days
patiromer sorbitex calcium
Vifor Pharma Pty Ltd
Veltassa is indicated for the treatment of hyperkalaemia in adults.
MONOFER
Evaluation commenced: 1 November 2016
Registration decision: 29 November 2017
Entry onto ARTG: 4 December 2017
Approval time: 234 working days
ferric derisomaltose
Link Medical Products Pty Ltd
Monofer is indicated for the treatment of iron deficiency in adults, under the following conditions:
- When oral iron preparations are ineffective or cannot be used;
- Where there is a clinical need to deliver iron rapidly.
The diagnosis must be based on laboratory tests.
November 2017
TRESIBA FLEXTOUCH and TRESIBA PENFILL
Evaluation commenced: 31 October 2016
Registration decision: 24 November 2017
Entry onto ARTG: 29 November 2017
Approval time: 228 working days
insulin degludec (rys)
Novo Nordisk Pharmaceuticals Pty Ltd
Tresiba Flextouch and Tresiba Penfill are indicated to improve glycaemic control in adult patients with diabetes mellitus requiring insulin.
RYZODEG 70/30 FLEXTOUCH and RYZODEG 70/30 PENFILL
Evaluation commenced: 31 October 2016
Registration decision: 24 November 2017
Entry onto ARTG: 29 November 2017
Approval time: 228 working days
70% insulin degludec (rys) / 30% insulin aspart (rys)
Novo Nordisk Pharmaceuticals Pty Ltd
Ryzodeg 70/30 Flextouch and Ryzodeg 70/30 Penfill are indicated to improve glycaemic control in adult patients with diabetes mellitus requiring basal and prandial insulin.
ZINPLAVA
Evaluation commenced: 30 November 2016
Registration decision: 8 November 2017
Entry onto ARTG: 13 November 2017
Approval time: 192 working days
bezlotoxumab (rch)
Merck Sharp & Dohme Australia Pty Ltd
Zinplava is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adult patients 18 years or older at high risk for recurrence of CDI who are receiving antibiotic therapy for CDI. Zinplava should only be used in conjunction with antibacterial drug treatment of CDI.
SPINRAZA
Evaluation commenced: 4 January 2017
Registration decision: 2 November 2017
Entry onto ARTG: 3 November 2017
Approval time: 167 working days
nusinersen (as heptadecasodium)
Biogen Australia Pty Ltd
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy (SMA).
INFLUVAC TETRA
Evaluation commenced: 30 November 2016
Registration decision: 1 November 2017
Entry onto ARTG: 2 November 2017
Approval time: 189 working days
influenza virus haemagglutinin vaccine
Mylan Health Pty Ltd
Influvac Tetra is indicated for the prevention of influenza caused by influenza virus, types A and B, in adults (18 years of age and older).
October 2017
ONCASPAR
Evaluation commenced: 30 September 2016
Registration decision: 19 October 2017
Entry onto ARTG: 31 October 2017
Approval time: 226 working days
pegaspargase
Baxalta Australia Pty Ltd
Oncaspar is indicated as a component of antineoplastic combination therapy in patients with Acute Lymphoblastic Leukaemia (ALL).
KISQALI
Evaluation commenced: 31 October 2016
Registration decision: 20 October 2017
Entry onto ARTG: 23 October 2017
Approval time: 231 working days
ribociclib (as succinate)
Novartis Pharmaceuticals Australia Pty Ltd
Kisqali, in combination with an aromatase inhibitor, is indicated for the treatment of men and postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer, as an initial endocrine-based therapy.
RANEXA
Evaluation commenced: 29 May 2015
Registration decision: 12 May 2016
Entry onto ARTG: 13 October 2017
Approval time: 197 working days
ranolazine
A. Menarini Australia Pty Ltd
Ranexa is indicated in adults as add-on therapy for the symptomatic treatment of stable angina pectoris in patients taking maximum tolerated doses of a beta-blocker or a calcium channel blocker and have inadequate symptom control.
September 2017
TRUMENBA
Evaluation commenced: 29 July 2016
Registration decision: 12 September 2017
Entry onto ARTG: 14 September 2017
Approval time: 202 working days
meningococcal group B vaccine
Pfizer Australia Pty Ltd
Trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.
MONUROL
Evaluation commenced: 31 August 2016
Registration decision: 31 August 2017
Entry onto ARTG: 4 September 2017
Approval time: 209 working days
fosfomycin trometamol
Mayne Pharma International Pty Ltd
Monurol is indicated only for the treatment of acute uncomplicated lower urinary tract infections (acute cystitis) in females above 12 years of age caused by the following susceptible pathogens: Enterobacteriaceae (including Escherichia coli), Enterococcus faecalis.
August 2017
INTUNIV
Evaluation commenced: 31 May 2016
Registration decision: 16 August 2017
Entry onto ARTG: 22 August 2017
Approval time: 233 working days
guanfacine (as hydrochloride)
Shire Australia Pty Ltd
Intuniv is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in children and adolescents 6-17 years old, as monotherapy (when stimulants or atomoxetine are not suitable, not tolerated or have been shown to be ineffective) or as adjunctive therapy to psychostimulants (where there has been a sub-optimal response to psychostimulants). Intuniv must be used as part of a comprehensive ADHD management programme, typically including psychological, educational and social measures.
GALAFOLD
Evaluation commenced: 30 June 2016
Registration decision: 9 August 2017
Entry onto ARTG: 11 August 2017
Approval time: 221 working days
migalastat (as hydrochloride)
ERA Consulting (Australia) Pty Ltd
Galafold is indicated for long-term treatment of adult and adolescent patients 16 years and older with a confirmed diagnosis of Fabry disease (α-galactosidase A deficiency) and who have an amenable mutation.
July 2017
TECENTRIQ
Evaluation commenced: 31 July 2016
Registration decision: 26 July 2017
Entry onto ARTG: 27 July 2017
Approval time: 210 working days
atezolizumab (rch)
Roche Products Pty Ltd
Tecentriq is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with progression on or after prior chemotherapy. In patients with tumour EGFR or ALK genomic aberrations, Tecentriq should be used after progression on or after targeted therapy.
CINQAIR/CINQAERO
Evaluation commenced: 29 July 2016
Registration decision: 17 July 2017
Entry onto ARTG: 25 July 2017
Approval time: 201 working days
reslizumab
Teva Pharma Australia Pty Ltd
Cinqair/Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma (blood eosinophil count ≥400 cells/μL).
DENGVAXIA
Evaluation commenced: 30 June 2016
Registration decision: 13 July 2017
Entry onto ARTG: 20 July 2017
Approval time: 236 working days
Dengue tetravalent vaccine-live, attenuated
Sanofi-Aventis Australia Pty Ltd
Dengvaxia is indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 9 through 45 years of age living in endemic areas.
DARZALEX / JANSSEN DARATUMUMAB
Evaluation commenced: 30 November 2016
Registration decision: 12 July 2017
Entry onto ARTG: 17 July 2017
Approval time: 152 working days
daratumumab
Janssen-Cilag Pty Ltd
Darzalex / Janssen Daratumumab is indicated:
- in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy;
- as monotherapy, for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are refractory to both a PI and an immunomodulatory agent.
OCREVUS
Evaluation commenced: 30 June 2016
Registration decision: 3 July 2017
Entry onto ARTG: 13 July 2017
Approval time: 215 working days
ocrelizumab
Roche Products Pty Ltd
Ocrevus is indicated for the treatment of patients with:
- relapsing forms of multiple sclerosis (RMS) to delay the progression of physical disability and to reduce the frequency of relapse;
- primary progressive multiple sclerosis (PPMS) to delay the progression of physical disability.
June 2017
There were no new entries for June.
May 2017
PHEBURANE
Evaluation commenced: 2 May 2016
Registration decision: 19 May 2017
Entry onto ARTG: 30 May 2017
Approval time: 225 working days
sodium phenylbutyrate
Orpharma Pty Ltd
Pheburane is indicated for the management of hyperammonaemia associated with urea cycle disorders. Pheburane should be used with dietary protein restriction and, in some cases, dietary supplements (e.g. essential amino acids, arginine, citrulline, and protein-free calorie supplements).
LONSURF/ORCANTAS
Evaluation commenced: 2 February 2016
Registration decision: 19 May 2017
Entry onto ARTG: 23 May 2017
Approval time: 232 working days
trifluridine/tipiracil hydrochloride
Servier Laboratories (Aust) Pty Ltd
Lonsurf/Orcantas is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.
UROREC
Evaluation commenced: 31 May 2016
Registration decision: 18 May 2017
Entry onto ARTG: 23 May 2017
Approval time: 197 working days
silodosin
Mayne Pharma International Pty Ltd
Urorec is indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia in adult men.
REXULTI
Evaluation commenced: 29 April 2016
Registration decision: 17 May 2017
Entry onto ARTG: 19 May 2017
Approval time: 231 working days
brexipiprazole
Lundbeck Australia Pty Limited
Rexulti is indicated in adult patients for the treatment of schizophrenia.
REVESTIVE
Evaluation commenced: 31 May 2016
Registration decision: 17 May 2017
Entry onto ARTG: 19 May 2017
Approval time: 196 working days
teduglutide
Shire Australia Pty Ltd
Revestive is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Patients should be stable at least to 4 weeks on their parenteral support regimen before initiating teduglutide therapy.
KANUMA
Evaluation commenced: 31 May 2016
Registration decision: 17 May 2017
Entry onto ARTG: 18 May 2017
Approval time: 220 working days
sebelipase alfa rce
Alexion Pharmaceuticals Australasia Pty Ltd
Kanuma is indicated for long-term enzyme replacement therapy (ERT) in patients of all ages with lysosomal acid lipase deficiency (LAL-D).
IBRANCE
Evaluation commenced: 31 May 2016
Registration decision: 28 April 2017
Entry onto ARTG: 3 May 2017
Approval time: 182 working days
palbociclib
Pfizer Australia Pty Ltd
Ibrance is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy
- fulvestrant in patients who have received prior therapy.
April 2017
AFSTYLA
Evaluation commenced: 29 February 2016
Registration decision: 29 March 2017
Entry onto ARTG: 13 April 2017
Approval time: 228 working days
lonoctocog alfa (recombinant single-chain coagulation factor VIII)
CSL Behring Australia Pty Ltd
Afstyla is indicated in adult and paediatric patients with haemophilia A (congenital FVIII deficiency) for:
- Control and prevention of bleeding episodes
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- Perioperative management (surgical prophylaxis).
Afstyla is not indicated for the treatment of von Willebrand disease.
March 2017
REKOVELLE
Evaluation commenced: 29 February 2016
Registration decision: 24 March 2017
Entry onto ARTG: 31 March 2017
Approval time: 224 working days
follitropin delta (rhu)
Ferring Pharmaceuticals Pty Ltd
Controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies (ART) such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
ADYNOVATE
Evaluation commenced: 29 April 2016
Registration decision: 15 March 2017
Entry onto ARTG: 21 March 2017
Approval time: 180 working days
rurioctocog alfa pegol (antihaemophilic factor VIII Recombinant Coagulation Factor VIII rch)
Baxalta Australia Pty Ltd
Adynovate is a long-acting antihaemophilic factor (recombinant) indicated in haemophilia A (congenital factor VIII deficiency) patients for:
- Control and prevention of bleeding episodes
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
- Perioperative management (surgical prophylaxis).
It is not indicated for the treatment of von Willebrand disease.
ALECENSA
Evaluation commenced: 4 April 2016
Registration decision: 10 March 2017
Entry onto ARTG: 14 March 2017
Approval time: 210 working days
alectinib
Roche Products Pty Ltd
For the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.
GRAZAX
Evaluation commenced: 29 January 2016
Registration decision: 24 February 2017
Entry onto ARTG: 7 March 2017
Approval time: 231 working days
standardised allergen extract of grass pollen from Timothy grass (Phleum pratense)
Seqirus Pty Ltd
For disease modifying treatment of grass pollen (Phleum pratense or allergens cross reacting with P. pratense) induced allergic rhinitis with or without conjunctivitis in adults, adolescents and children above the age of 5 years.
February 2017
ZEMAIRA
Evaluation commenced: 31 March 2016
Registration decision: 9 February 2017
Entry onto ARTG: 13 February 2017
Approval time: 177 working days
human alpha-1-proteinase inhibitor
CSL Behring Australia Pty Ltd
For maintenance treatment to slow the progression of emphysema in adults with documented severe A1-PI deficiency and progressive lung disease.
January 2017
VENCLEXTA
Evaluation commenced: 29 February 2016
Registration decision: 15 December 2016
Entry onto ARTG: 5 January 2017
Approval time: 179 working days
venetoclax
Abbvie Pty Ltd
For the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) with 17p deletion, or patients with relapsed or refractory CLL for whom there are no other suitable treatment options.
Previous years
Prescription medicines registrations database from 2018 onwards
Visit our Prescription medicines registrations database to see the registration of NCEs for each year from 2018 onwards.