Prescription medicines: registration of new chemical entities in Australia, 2014

4 May 2015

2014 summary

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The Prescription medicines: annual summary 2014 publication provides details of NCEs registered in 2014:

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 orphan drug

Registration of NCEs, 2014

Dec Nov Oct Sep Aug Jul Jun May Apr Mar Feb Jan

December 2014

New prescription medicines containing new active substances in December 2014
Medicine Date registered

ADENURIC

febuxostat

Sponsor: A. Menarini Australia Pty Ltd

Treatment of chronic symptomatic hyperuricaemia in adults with gout.

18 Dec 2014

VIMIZIM orphan drug

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

New prescription medicines containing new active substances in November 2014
Medicine Date registered

VELPHORO

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

ICLUSIG orphan drug

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

PLEGRIDY

peginterferon beta-1a (rch)

Sponsor: Biogen Idec Australia Pty Ltd

For the treatment of relapsing forms of multiple sclerosis.

10 Nov 2014

October 2014

New prescription medicines containing new active substances in October 2014
Medicine Date registered

JETREA

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

New prescription medicines containing new active substances in September 2014
Medicine Date registered

HEXAXIM

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

New prescription medicines containing new active substances in July 2014
Medicine Date registered

OLYSIO

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

INCRUSE ELLIPTA

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

ANORO ELLIPTA

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

POMALYST orphan drug

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

New prescription medicines containing new active substances in June 2014
Medicine Date registered

RIBOMUSTIN

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

SOVALDI

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

ENTYVIO

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

ELOCTATE orphan drug

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

New prescription medicines containing new active substances in May 2014
Medicine Date registered

FYCOMPA

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

ELELYSO orphan drug

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

XOFIGO

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

GAZYVA

obinutuzumab

Sponsor: Roche Products Pty Ltd

For use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukaemia.

15 May 2014

HIZENTRA

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

ALPROLIX orphan drug

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

New prescription medicines containing new active substances in April 2014
Medicine Date registered

JARDIANCE

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 orphan drug

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

BREO ELLIPTA

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

LATUDA

lurasidone hydrochloride

Sponsor: Commercial Eyes Pty Ltd

To treat symptoms of schizophrenia in adults.

16 Apr 2014

ADEMPAS orphan drug

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

New prescription medicines containing new active substances in March 2014
Medicine Date registered

BRINTELLIX

vortioxetine hydrobromide

Sponsor: Lundbeck Australia Pty Ltd

To treat major depression in adults.

31 Mar 2014

BRETARIS GENUAIR

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

XEOMIN

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

New prescription medicines containing new active substances in February 2014
Medicine Date registered

MEKINIST orphan drug

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

DIGIFAB orphan drug

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

RIXUBIS orphan drug

nonacog gamma

Sponsor: Baxter Healthcare Pty Ltd

Used to control or prevent bleeding in adult patients with haemophilia B.

5 Feb 2014

OPSUMIT orphan drug

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

New prescription medicines containing new active substances in January 2014
Medicine Date registered

TIVICAY

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

LOTEMAX

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

NOVOEIGHT orphan drug

turoctocog alfa

Sponsor: Novo Nordisk Pharmaceuticals Pty Ltd

Used to control or prevent bleeding in patients with haemophilia A.

8 Jan 2014