Prescription medicines: registration of new chemical entities in Australia, 2014
Registration of new chemical entities in Australia
The Therapeutic Goods Administration (TGA) registered 39 new prescription medicines containing new active substances in 2014. These are called New Chemical Entities (NCEs) by the TGA.
Some of these NCE's are innovative or 'first-in-class', and have been made available for the first time outside the controlled environment of a clinical trial.
From mid-2015 these registrations will be published on a regular basis on the TGA website.
Timeliness and predictability
All of the prescription medicine NCEs registered by the TGA in 2014 were approved within the legislated timeframe.
In 2014
7 of the NCEs registered are considered to be innovative, for example, by having a new or unique mechanism of action over existing therapies.
About one third of these medicines were designated to be orphan drugs by the TGA. A medicine, vaccine or in vivo diagnostic agent is designated as an 'orphan drug' 
if it:
- is intended to treat, prevent or diagnose a rare disease; or
- is not commercially viable to supply to treat, prevent or diagnose another disease or condition.
Innovative or 'first-in-class' new prescription medicines
FYCOMPA – for the treatment of epilepsy
SOVALDI – for the treatment of chronic hepatitis C infection
XOFIGO – To treat men with castration-resistant prostate cancer
ADEMPAS – To treat certain types of pulmonary hypertension
VIMIZIM – For the treatment of mucopolysaccharidosis IV, Type A (Morquio A syndrome, MPS IVA)
MEKINIST – For the treatment of patients with advanced melanomas
JETREA – For the treatment of vitreomacular traction (VMT)
2014 Chronological summary
The trade name, sponsor and active ingredient for each medicine reflects the information initially entered in the Australian Register of Therapeutic Goods (ARTG). This list contains links to published Australian Public Assessment Reports (AusPAR). The AusPAR provides more information about the evaluation of the medicine and the considerations that led the TGA to register it.
Orphan drug
Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan
December 2014
| Medicine | Date registered |
|---|---|
|
febuxostat Sponsor: A. Menarini Australia Pty Ltd Treatment of chronic symptomatic hyperuricaemia in adults with gout. |
18 Dec 2014 |
|
elosulfase alfa (rch) Sponsor: BioMarin Pharmaceutical Australia Pty Ltd An enzyme replacement therapy for the treatment of mucopolysaccharidosis IV, Type A (Morquio A syndrome, MPS IVA), a severely debilitating and progressive disease due to accumulation of certain polysaccharides in the body that can result in significant physical impairment, impaired quality of life, and early mortality. |
9 Dec 2014 |
|
FLUQUADRI and FLUQUADRI JUNIOR influenza virus haemagglutinin Sponsor: Sanofi-Aventis Australia Pty Ltd FluQuadri and FluQuadri Junior are indicated for active immunisation of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FluQuadri is indicated for use in adults and children 3 years and older. FluQuadri Junior is indicated for use in children aged 6 months to 35 months inclusive. |
2 Dec 2014 |
November 2014
| Medicine | Date registered |
|---|---|
|
sucroferric oxyhydroxide Sponsor: Fresenius Medical Care Australia Pty Ltd To control serum phosphorus levels in adult patients with chronic kidney disease on dialysis. |
27 Nov 2014 |
|
ponatinib hydrochloride Sponsor: ARIAD Pharmaceuticals Australia Pty Ltd For the treatment of adult patients with certain types of leukaemia. |
26 Nov 2014 |
|
NUWIQ simoctocog alfa Sponsor: Octapharma Australia Pty Ltd Used to control or prevent bleeding in previously treated paediatric (< 2 years) and adult patients with haemophilia A. |
10 Nov 2014 |
|
peginterferon beta-1a (rch) Sponsor: Biogen Idec Australia Pty Ltd For the treatment of relapsing forms of multiple sclerosis. |
10 Nov 2014 |
October 2014
| Medicine | Date registered |
|---|---|
|
ocriplasmin Sponsor: Alcon Laboratories Australia Pty Ltd For the treatment of vitreomacular traction (VMT) in adults, a condition where the vitreous gel sticks to the retina and can result in subsequent loss or distortion of vision and damage to the eye. |
9 Oct 2014 |
September 2014
| Medicine | Date registered |
|---|---|
|
diphtheria toxoid, haemophilus type B polysaccharide, hepatitis B surface antigen, pertussis filamentous haemagglutinin, pertussis toxoid, poliovirus, tetanus protein, tetanus toxoid Sponsor: Sanofi-Aventis Australia Pty Ltd For vaccination of infants from six weeks of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive infections caused by Haemophilus influenzae type b. |
11 Sep 2014 |
July 2014
| Medicine | Date registered |
|---|---|
|
simeprevir (as sodium) Sponsor: Janssen-Cilag Pty Ltd Used in combination with other antiviral medicines to treat chronic hepatitis C infection in adults. |
18 Jul 2014 |
|
umeclidinium (as bromide) Sponsor: GlaxoSmithKline Australia Pty Ltd For use as maintenance therapy in adult patients with chronic obstructive pulmonary disease (COPD). |
8 Jul 2014 |
|
umeclidinium bromide/vilanterol trifenatate Sponsor: GlaxoSmithKline Australia Pty Ltd For use as maintenance therapy in adult patients with chronic obstructive pulmonary disease (COPD). |
4 Jul 2014 |
|
pomalidomide Sponsor: Celgene Australia Pty Ltd Used in combination with dexamethasone for the treatment of patients with multiple myeloma whose disease has progressed despite treatment with other anticancer medicines. |
1 Jul 2014 |
|
XTANDI enzalutamide Sponsor: Astellas Pharma Australia Pty Ltd For the treatment of men with metastatic castration-resistant prostate cancer who have previously received docetaxel. |
1 Jul 2014 |
June 2014
| Medicine | Date registered |
|---|---|
|
bendamustine hydrochloride Sponsor: Janssen-Cilag Pty Ltd For treatment of certain types of chronic lymphocytic leukaemia, Non-Hodgkin's lymphoma, and Mantle Cell Lymphoma. |
30 Jun 2014 |
|
sofosbuvir Sponsor: Gilead Sciences Pty Ltd For use in combination with other antiviral medicines to treat chronic hepatitis C infection in adults. |
30 Jun 2014 |
|
vedolizumab (rch) Sponsor: Takeda Pharmaceuticals Australia Pty Ltd Treatment of adults with moderate to severe ulcerative colitis or Crohn's disease who have had an inadequate response with, lost response to, or are intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist. |
27 Jun 2014 |
|
efraloctocog alfa Sponsor: Biogen Idec Australia Pty Ltd A long-acting anti-haemophilic factor to control or prevent bleeding in adults and children ≥ 12 years with haemophilia A. |
27 Jun 2014 |
May 2014
| Medicine | Date registered |
|---|---|
|
perampanel (as hemisesquihydrate) Sponsor: Eisai Australia Pty Ltd For use in conjunction with other medicines to treat partial-onset seizures in patients with epilepsy aged 12 years and older. |
23 May 2014 |
|
taliglucerase alfa rpc Sponsor: Pfizer Australia Pty Ltd For long-term enzyme replacement therapy in adults and children with Type 1 Gaucher disease. |
21 May 2014 |
|
radium (223Ra) dichloride Sponsor: Bayer Australia Ltd To treat men with castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease. |
20 May 2014 |
|
obinutuzumab Sponsor: Roche Products Pty Ltd For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukaemia. |
15 May 2014 |
|
normal human immunoglobulin Sponsor: CSL Behring Australia Pty Ltd Replacement therapy in adults and children with primary immunodeficiency disease (PID) and symptomatic hypogammaglobulinaemia secondary to underlying disease or treatment. |
8 May 2014 |
|
eftrenonacog alfa Sponsor: Biogen Idec Australia Pty Ltd A long-acting anti-haemophilic factor to control or prevent bleeding in adults and children ≥ 12 years with haemophilia B. |
1 May 2014 |
April 2014
| Medicine | Date registered |
|---|---|
|
empagliflozin Sponsor: Boehringer Ingelheim Pty Ltd For use alone or in combination with other medicines to improve blood sugar control in adults with Type 2 diabetes. |
30 Apr 2014 |
|
BOSULIF bosutinib Sponsor: Pfizer Australia Pty Ltd For the treatment of chronic, accelerated or blast phase Philadelphia chromosome-positive (Ph+) chronic myeloid leukaemia in adults previously treated with two or more tyrosine kinase inhibitors. |
29 Apr 2014 |
|
fluticasone furoate/vilanterol trifenatate Sponsor: GlaxoSmithKline Australia Pty Ltd For use as maintenance therapy in patients with chronic obstructive pulmonary disease (COPD) or moderate to severe asthma. |
17 Apr 2014 |
|
lurasidone hydrochloride Sponsor: Commercial Eyes Pty Ltd To treat symptoms of schizophrenia in adults. |
16 Apr 2014 |
|
riociguat Sponsor: Bayer Australia Ltd As monotherapy or in combination with other medicines to treat certain types of pulmonary hypertension in adult patients. |
14 Apr 2014 |
March 2014
| Medicine | Date registered |
|---|---|
|
vortioxetine hydrobromide Sponsor: Lundbeck Australia Pty Ltd To treat major depression in adults. |
31 Mar 2014 |
|
aclidinium bromide Sponsor: A. Menarini Australia Pty Ltd For use as maintenance therapy in adult patients with chronic obstructive pulmonary disease (COPD). |
25 Mar 2014 |
|
incobotulinum toxin A Sponsor: Merz Australia Pty Ltd For use in adults for the treatment of painful involuntary contraction of neck muscles, involuntary contraction of the eyelid muscles, post-stroke abnormal muscle rigidity affecting the arms, and frown lines between the eyes. |
21 Mar 2014 |
February 2014
| Medicine | Date registered |
|---|---|
|
trametinib (as dimethyl sulfoxide) Sponsor: GlaxoSmithKline Australia Pty Ltd Used alone or in combination with dabrafenib for the treatment of patients with advanced melanomas that express the BRAFV600 mutation. |
14 Feb 2014 |
|
digoxin-specific antibody fragment f(Ab) (ovine) Sponsor: Phebra Pty Ltd For the treatment of known (or strongly suspected) life-threatening digoxin toxicity. |
14 Feb 2014 |
|
nonacog gamma Sponsor: Baxter Healthcare Pty Ltd Used to control or prevent bleeding in adult patients with haemophilia B. |
5 Feb 2014 |
|
macitentan Sponsor: Actelion Pharmaceuticals Australia Pty Ltd As monotherapy or in combination with other medicines to treat certain types of pulmonary hypertension in adult patients. |
5 Feb 2014 |
January 2014
| Medicine | Date registered |
|---|---|
|
dolutegravir (as sodium) Sponsor: ViiV Healthcare Pty Ltd Used in combination with other antiviral medicines to treat human immunodeficiency virus (HIV) infection in adults and children over 12 years of age. |
17 Jan 2014 |
|
loteprednol etabonate Sponsor: Bausch & Lomb Australia Pty Ltd For the treatment of inflammation of the eye following cataract surgery or due to contact lens associated giant papillary conjunctivitis that is responsive to steroids. |
16 Jan 2014 |
|
turoctocog alfa Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd Used to control or prevent bleeding in patients with haemophilia A. |
8 Jan 2014 |
Registrations 2017-2015
Prescription medicines registrations database from 2018 onwards
Visit our Prescription medicines registrations database to see the registration of NCEs from 2018 onwards.
Prescription medicines registrations