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

4 October 2018

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, 2018

Previous years

2017 2016

September 2018

LENVIMA orphan drug

Evaluation commenced: 31 Oct 2017

Registration decision: 19 Sep 2018

Date registered: 21 Sep 2018

Approval time: 182 working days (255)

lenvatinib (as mesilate)

Eisai Australia Pty Ltd

LENVIMA (hard capsules) is now also indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

NOTEN

Evaluation commenced: 19 Jul 2018

Registration decision: 7 Sep 2018

Date registered: 20 Sep 2018

Approval time: 70 working days (255)

Atenolol

Alphapharm Pty Ltd

Generic medicine

NOTEN (tablets) is now also indicated for the management of Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction.

CLOPIDOGREL SG

Evaluation commenced: 9 Jul 2018

Registration decision: 30 Aug 2018

Date registered: 19 Sep 2018

Approval time: 45 working days (255)

clopidogrel besilate

Southern Cross Pharma Pty Ltd

Generic medicine

CLOPIDOGREL SG (tablets) is now also indicated for:

Acute Coronary Syndrome

Clopidogrel is indicated in combination with aspirin for patients with:

  • Unstable angina or non-ST-elevation myocardial infarction in order to prevent early and long-termatherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Clopidogrel is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent).
  • ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In thispopulation, clopidogrel has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

OPDIVO

Evaluation commenced: 8 Jun 2017

Registration decision: 17 Sep 2018

Date registered: 18 Sep 2018

Approval time: 211 working days (255)

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

OPDIVO (concentrated solution for IV infusion) is now also indicated for:

  • Hepatocellular Carcinoma - OPDIVO, as monotherapy, is indicated for the treatment of patients with hepatocellular carcinoma after prior sorafenib therapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established.

HIZENTRA

Evaluation commenced: 7 Jul 2017

Registration decision: 11 Sep 2018

Date registered: 14 Sep 2018

Approval time: 218 working days (255)

normal immunoglobulin

CSL Behring Australia Pty Ltd

HIZENTRA (Solution for Subcutaneous Injection) is now also indicated for Immunomodulatory therapy in:

  • Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) as maintenance therapy after stabilisation with IVIg.

PERJETA

Evaluation commenced: 8 Sep 2017

Registration decision: 4 Aug 2018

Date registered: 10 Sep 2018

Approval time: 189 working days (255)

Pertuzumab

Roche Products Pty Ltd

PERJETA (injection) is now also indicated in combination with trastuzumab and chemotherapy for:

  • the neoadjuvant treatment of patients with HER2-positive inflammatory or locally advanced, or early stage (either > 2 cm in diameter or node positive) breast cancer as part of a complete treatment regimen for early breast cancer
  • the adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence.

NIMENRIX

Evaluation commenced: 1 Aug 2017

Registration decision: 4 Sep 2018

Date registered: 5 Sep 2018

Approval time: 200 working days (255)

Meningococcal polysaccharide group W135; Meningococcal polysaccharide group C; Meningococcal polysaccharide Group Y; Tetanus toxoid; Meningococcal polysaccharide group A

Pfizer Australia Pty Ltd

NIMENRIX (injection) is now indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal diseases caused by Neisseria meningitidis groups A, C, W-135 and Y.

August 2018

CONTRAVE

Evaluation commenced: 7 Jun 2017

Registration decision: 21 Aug 2018

Date registered: 21 Aug 2018

Approval time: 203 working days (255)

naltrexone hydrochloride; bupropion hydrochloride

iNova Pharmaceuticals (Australia) Pty Ltd

New conbination

CONTRAVE (tablets) is indicated, as an adjunct to a reduced-calorie diet and increased physical activity, for the management of weight in adult patients (≥18 years) with an initial Body Mass Index (BMI) of:

  • ≥ 30 kg/m2 (obese), or
  • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of one or more weight-related co-morbidities (e.g., type 2 diabetes, dyslipidaemia, or controlled hypertension).

ZYTIGA

Evaluation commenced: 30 Nov 2017

Registration decision: 15 Aug 2018

Date registered: 17 Aug 2018

Approval time: 155 working days (255)

Abiraterone acetate

Janssen-Cilag Pty Ltd

ZYTIGA (tablets) is now also indicated for the treatment of newly diagnosed high-risk metastatic hormone sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).

VIMPAT

Evaluation commenced: 31 Mar 2017

Registration decision: 25 Jul 2018

Date registered: 14 Aug 2018

Approval time: 250 working days (255)

Lacosamide

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

VIMPAT (injection/tablets) is now also indicated as monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older .

ORKAMBI orphan drug

Evaluation commenced: 4 Jul 2017

Registration decision: 10 Aug 2018

Date registered: 13 Aug 2018

Approval time: 229 working days (255)

Ivacaftor; lumacaftor

Vertex Pharmaceuticals Australia Pty Ltd

ORKAMBI (tablets) is now also indicated for the treatment of cystic fibrosis (CF) in patients age 6 to 11 years who are homozygous for the F508del mutation in the CFTR gene.

LYNPARZA

Evaluation commenced: 29 Sep 2017

Registration decision: 1 Aug 2018

Date registered: 7 Aug 2018

Approval time: 171 working days (255)

olaparib

AstraZeneca Pty Ltd

LYNPARZA (Tabalets) is now indicated as monotherapy for the treatment of adult patients with germline BRCA mutated HER2-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Germline BRCA mutation (gBRCAm) status should be determined by an experienced laboratory using a validated test method.

REPATHA

Evaluation commenced: 1 Aug 2017

Registration decision: 2 Aug 2018

Date registered: 6 Aug 2018

Approval time: 183 working days (255)

evolocumab

Amgen Australia Pty Ltd

REPATHA (solution for injection) is now indicated as an adjunct to diet and exercise in:

Prevention of Cardiovascular Events

REPATHA is indicated to reduce the risk of cardiovascular events (myocardial infarction, stroke and coronary revascularisation) in adults with established cardiovascular disease in combination with an optimally dosed statin and/or other lipid-lowering therapies.

Primary hypercholesterolaemia

REPATHA is indicated in adults with primary hypercholesterolaemia (including heterozygous familial hypercholesterolaemia and non-familial hypercholesterolaemia) to reduce low-density lipoprotein cholesterol (LDL-C):

  • in combination with a statin or statin with other lipid lowering therapies, or
  • alone or in combination with other lipid-lowering therapies in patients who are statin intolerant.

BYDUREON

Evaluation commenced: 31 Aug 2017

Registration decision: 25 Jul 2018

Date registered: 1 Aug 2018

Approval time: 183 working days (255)

Exenatide

AstraZeneca Pty Ltd

BYDUREON (once weekly injection) is now also indicated for use in combination with dapagliflozin as add on therapy to metformin in patients with type 2 diabetes mellitus who have not achieved adequate glycaemic control on metformin alone.

July 2018

BYDUREON

Evaluation commenced: 31 Mar 2017

Registration decision: 25 Jul 2018

Date registered: 31 Jul 2018

Approval time: 253 working days (255)

Exenatide

AstraZeneca Pty Ltd

BYDUREON (once weekly injection) is now also indicated for the treatment of type 2 diabetes mellitus to improve glycaemic control in combination with basal insulin, with or without metformin.

XGEVA

Evaluation commenced: 29 Sep 2017

Registration decision: 20 Jul 2018

Date registered: 27 Jul 2018

Approval time: 161 working days (255)

Denosumab

Amgen Australia Pty Ltd

XGEVA (solution for injection) is now also indicated for the prevention of skeletal related events in patients with multiple myeloma and in patients with bone metastases from solid tumours.

BERINERT SC orphan drug

Evaluation commenced: 31 Aug 2017

Registration decision: 9 Jul 2018

Date registered: 12 Jul 2018

Approval time: 171 working days (255)

C1 esterase inhibitor

CSL Behring Australia Pty Ltd

BERINERT SC subcutaneous injection is now also indicated for prevention of recurrent Hereditary Angioedema (HAE) attacks in adolescent and adult patients with C1 esterase inhibitor deficiency.

OPDIVO priority review

Evaluation commenced: 7 Dec 2017

Registration decision: 4 Jul 2018

Date registered: 9 Jul 2018

Approval time: 140 working days (255)

Nivolumab

Bristol-Myers Squibb Australia Pty Ltd

OPDIVO, in combination YERVOY (ipilimumab), is now also indicated for the treatment of patients with intermediate/poor-risk, previously untreated advanced renal cell carcinoma.

OPDIVO

Evaluation commenced: 1 Aug 2017

Registration decision: 4 Jul 2018

Date registered: 6 Jul 2018

Approval time: 187 working days (255)

Nivolumab

Bristol-Myers Squibb Australia Pty Ltd

OPDIVO, in combination with YERVOY (ipilimumab), is now also indicated for the treatment of patients with unresectable or metastatic melanoma. The approval of this indication is based on a pre-specified comparison to ipilimumab monotherapy. All analyses comparing nivolumab monotherapy with the nivolumab/ipilimumab combination are descriptive.

TAGRISSO priority review

Evaluation commenced: 10 Jan 2018

Registration decision: 3 Jul 2018

Date registered: 5 Jul 2018

Approval time: 119 working days (255)

Osimertinib mesilate

AstraZeneca Pty Ltd

TAGRISSO (tablets) is now also indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating epidermal growth factor receptor (EGFR) mutations.

June 2018

ILEVRO

Evaluation commenced: 4 Jul 2017

Registration decision: 22 Jun 2018

Date registered: 28 Jun 2018

Approval time: 229 working days (255)

Nepafenac

Novartis Pharmaceuticals Australia Pty Ltd

ILEVRO (eye drops) is now also indicated for the reduction in risk of postoperative macular oedema associated with cataract surgery in patients with non proliferative diabetic retinopathy.

TALTZ

Evaluation commenced: 31 Aug 2017

Registration decision: 22 Jun 2018

Date registered: 27 Jun 2018

Approval time: 180 working days (255)

Ixekizumab

Eli Lilly Australia Pty Ltd

TALTZ (injections) is now also indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately, or who are intolerant, to previous DMARD therapy. Taltz may be used as monotherapy or in combination with a conventional DMARD (e.g.methotrexate).

PROLIA

Evaluation commenced: 1 Jun 2017

Registration decision: 15 Jun 2018

Date registered: 22 Jun 2018

Approval time: 221 working days (255)

Denosumab

Amgen Australia Pty Ltd

PROLIA (injections) is now also indicated for the treatment to increase bone mass in women and men at increased risk of fracture due to long-term systemic glucocorticoid therapy.

JULUCA

Evaluation commenced: 31 Aug 2017

Registration decision: 18 Jun 2018

Date registered: 20 Jun 2018

Approval time: 169 working days (255)

Rilpivirine hydrochloride; dolutegravir

ViiV Healthcare Pty Ltd

New conbination

JULUCA (tablets) is now also indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months with no history of virological failure and no known or suspected resistance to any non-nucleoside reverse transcriptase inhibitor or integrase inhibitor.

KEYTRUDA

Evaluation commenced: 2 May 2017

Registration decision: 8 Jun 2018

Date registered: 15 Jun 2018

Approval time: 168 working days (255)

Pembrolizumab

Merck Sharp & Dohme (Australia) Pty Ltd

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is now also indicated for the first-line treatment of patients with metastatic non-squamous NSCLCs. This indication is approved based on tumour response rate and progression-free survival in a Phase-2 trial.

TAFINLAR priority review

Evaluation commenced: 16 Jan 2018

Registration decision: 6 Jun 2018

Date registered: 8 Jun 2018

Approval time: 96 working days (255)

Dabrafenib mesilate

Novartis Pharmaceuticals Australia Pty Ltd

TAFINLAR is now also indicated for:

  • Adjuvant treatment of melanoma

TAFINLAR in combination with trametinib is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.

MEKINIST priority review

Evaluation commenced: 16 Jan 2018

Registration decision: 6 Jun 2018

Date registered: 8 Jun 2018

Approval time: 96 working days (255)

Trametinib as dimethyl sulfoxide

Novartis Pharmaceuticals Australia Pty Ltd

MEKINIST is now also indicated for:

  • Adjuvant treatment of melanoma

MEKINIST in combination with dabrafenib is indicated for the adjuvant treatment of patients with melanoma with a BRAF V600 mutation and involvement of the lymph node(s), following complete resection.

DYSPORT

Evaluation commenced: 31 Oct 2017

Registration decision: 7 Jun 2018

Date registered: 8 Jun 2018

Approval time: 149 working days (255)

Clostridium botulinum type a toxin haemagglutinin complex

Ipsen Pty Ltd

DYSPORT (containing clostridium botulinum type a toxin haemagglutinin complex) is now also indicated for the treatment of moderate to severe glabellar lines and , or lateral canthal lines (crow's feet) in adults.

LUCASSIN orphan drug

Evaluation commenced: 29 Jun 2017

Registration decision: 29 May 2018

Date registered: 7 Jun 2018

Approval time: 201 working days (255)

Terlipressin

Ikaria Australia Pty Ltd

LUCASSIN (injection) is now also indicated for the treatment of bleeding oesophageal varices.

May 2018

FLUARIX TETRA

Evaluation commenced: 28 Apr 2017

Registration decision: 23 May 2018

Date registered: 29 May 2018

Approval time: 225 working days (255)

Influenza virus haemagglutinin

GlaxoSmithKline Australia Pty Ltd

FLUARIX TETRA quadrivalent vaccine is now also indicated for active immunisation of adults and children from 6 months of age for the prevention of influenza disease caused by the influenza virus types A and B contained in the vaccine.

ACARIZAX

Evaluation commenced: 28 Apr 2017

Registration decision: 25 May 2018

Date registered: 29 May 2018

Approval time: 205 working days (255)

American house dust mite extract, European house dust mite extract

Seqirus Pty Ltd

ACARIZAX (tablets) is now also indicated for the treatment of house dust mite (HDM) allergic rhinitis not well controlled despite use of symptom relieving medication in adults and adolescents (age; 12 years)

ADCETRIS orphan drug

Evaluation commenced: 30 Jun 2017

Registration decision: 23 May 2018

Date registered: 25 May 2018

Approval time: 185 working days (255)

Brentuximab vedotin

Takeda Pharmaceuticals Australia Pty Ltd

ADCETRIS (powder for injection) is now also indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy.

ZYKADIA orphan drug

Evaluation commenced: 31 May 2017

Registration decision: 23 May 2018

Date registered: 25 May 2018

Approval time: 209 working days (255)

Ceritinib

Novartis Pharmaceuticals Australia Pty Ltd

ZYKADIA (capsules) is also now indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive

LYNPARZA

Evaluation commenced: 31 May 2017

Registration decision: 18 May 2018

Date registered: 23 May 2018

Approval time: 231 working days (255)

Olaparib

AstraZeneca Pty Ltd

LYNPARZA (tablets) is now also indicated as a monotherapy for the maintenance treatment of adult patients with platinum- sensitive relapsed high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete response or partial response) after platinum-based chemotherapy. Prior treatment must have included at least 2 courses of platinum-based regimens.

STEGLUJAN

Evaluation commenced: 31 May 2017

Registration decision: 14 May 2018

Date registered: 17 May 2018

Approval time: 235 working days (255)

Ertugliflozin and sitagliptin phosphate monohydrate

Merck Sharp & Dohme (Australia) Pty Ltd

New conbination

Steglujan (tablets) now also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and sitagliptin is appropriate.

SEGLUROMET

Evaluation commenced: 31 May 2017

Registration decision: 14 May 2018

Date registered: 17 May 2018

Approval time: 236 working days (255)

Ertugliflozin and metformin hydrochloride

Merck Sharp & Dohme (Australia) Pty Ltd

New conbination

Segluromet (tablets) is now also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both ertugliflozin and metformin is appropriate.

BLINCYTO orphan drug

Evaluation commenced: 31 May 2017

Registration decision: 3 May 2018

Date registered: 7 May 2018

Approval time: 197 working days (255)

Blinatumomab

Amgen Australia Pty Ltd

BLINCYTO powder for injection is also now indicated for the treatment of minimal residual disease (MRD) positive B-cell precursor acute lymphoblastic leukaemia (ALL) in patients in complete haematological remission.

APOTENOFOVIR/EMTRICITABINE, TENOFOVIR/EMTRICITABINE APOTEX

Evaluation commenced: 23 Mar 2018

Registration decision: 30 Apr 2018

Date registered: 4 May 2018

Approval time: 26 working days (255)

Emtricitabine; Tenofovir disoproxil fumarate

Apotex Pty Ltd

Generic medicine

Pre-Exposure Prophylaxis

APO-Tenofovir/Emtricitabine 300/200 and Tenofovir/Emtricitabine 300/200 APOTEX is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.

April 2018

SPIRIVA RESPIMAT; SRIVASSO RESPIMAT; ESOVYND RESPIMAT; FAVINT RESPIMAT

Evaluation commenced: 31 May 2017

Registration decision: 26 Apr 2018

Date registered: 30 Apr 2018

Approval time: 190 working days (255)

Tiotropium bromide monohydrate

Boehringer Ingelheim Pty Ltd

Tiotropium bromide monohydrate solution for inhalation cartridge is now also indicated as an add-on maintenance bronchodilator treatment in children 6-11 years of age and adolescents in moderate to severe asthma.

OPDIVO priority review

Evaluation commenced: 23 Oct 2017

Registration decision: 23 Apr 2018

Date registered: 24 Apr 2018

Approval time: 124 working days (255)

Nivolumab

Bristol-Myers Squibb Australia Pty Ltd

OPDIVO, as monotherapy, is now also indicated for the treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

VACLOVIR

Evaluation commenced: 3 Apr 2018

Registration decision: 9 Apr 2018

Date registered: 20 Apr 2018

Approval time: 8 working days (255)

Valaciclovir hydrochloride

Alphapharm Pty Ltd

Generic medicine

VACLOVIR is now also indicated for the treatment of recurrent herpes labialis (cold sores).

GRANISETRON KABI

Evaluation commenced: 29 Jan 2018

Registration decision: 19 Mar 2018

Date registered: 18 Apr 2018

Approval time: 26 working days (255)

Granisetron hydrochloride

Fresenius Kabi Australia Pty Ltd

Generic medicine

GRANISETRON KABI is now also indicated for the prevention and treatment of post-operative nausea and vomiting in adults only.

QUETIAPINE SANDOZ

Evaluation commenced: 26 Feb 2018

Registration decision: 4 Apr 2018

Date registered: 13 Apr 2018

Approval time: 18 working days (255)

Quetiapine fumarate

Sandoz Pty Ltd

Generic medicine

SIMVASTATIN SANDOZ is now also indicated for the maintenance treatment of bipolar I disorder, as monotherapy for the prevention of relapse/recurrence of manic, depressive or mixed episodes

  • Treatment of depressive episodes associated with bipolar disorder (see Section 4.2 Dose and method of administration)
  • Monotherapy treatment of acute mania associated with bipolar I disorder in children/adolescents aged 10 to 17 years
  • Treatment of schizophrenia in adolescents aged 13 to 17 years.

MENACTRA

Evaluation commenced: 31 May 2017

Registration decision: 9 Apr 2018

Date registered: 13 Apr 2018

Approval time: 177 working days (255)

Meningococcal [groups A, C,Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine)

Sanofi-Aventis Australia Pty Ltd

MENACTRA solution for intramuscular injection is now also indicated for active immunisation of individuals 9 months through to 55 years of age for the prevention of invasive meningococcal disease caused by N meningitides serogroups A,C,Y and W135.

LATUDA

Evaluation commenced: 31 Mar 2017

Registration decision: 4 Apr 2018

Date registered: 5 Apr 2018

Approval time: 231 working days (255)

Lurasidone hydrochloride

Servier Laboratories Australia Pty Ltd

Latuda is now also indicated for the treatment of schizophrenia in adolescents (aged 13 to 17 years).

March 2018

DURATOCIN

Evaluation commenced: 28 Feb 2017

Registration decision: 16 Mar 2018

Date registered: 26 Mar 2018

Approval time: 219 working days (255)

carbetocin

Ferring Pharmaceuticals Pty Ltd

Duratocin is now also indicated for the treatment of the prevention of uterine atony and excessive bleeding following delivery of the infant by emergency caesarean section or vaginal delivery. Duratocin must be administered after delivery of the infant.

AZILECT-RASAGILINE

Evaluation commenced: 29 Jun 2017

Registration decision: 28 Mar 2018

Date registered: 22 Mar 2018

Approval time: 135 working days (255)

rasagiline

Teva Pharma Australia Pty Ltd

Azilect-Rasagiline is now also indicated as adjunct therapy to dopamine agonist or to levodovap.

GENVOYA

Evaluation commenced: 31 Mar 2017

Registration decision: 28 Mar 2018

Date registered: 20 Mar 2018

Approval time: 221 working days (255)

tenofovir alafenamide fumarate; emtricitabine; elvitegravir; cobicistat

Gilead Sciences Pty Ltd

Genvoya is now also indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 25kg.

SIMVASTATIN SANDOZ

Evaluation commenced: 2 Feb 2018

Registration decision: 13 Mar 2018

Date registered: 19 Mar 2018

Approval time: 27 working days (255)

Simvastatin

Sandoz Pty Ltd

Generic medicine

Simvastatin Sandoz is now also indicated as an adjunct to diet in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial J140hypercholesterolaemia (HeFH).

Prior to initiating therapy with Simvastatin Sandoz, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

XEOMIN

Evaluation commenced: 28 Apr 2017

Registration decision: 15 Mar 2018

Date registered: 15 Mar 2018

Approval time: 180 working days (255)

incobotulinum toxin A

Merz Australia Pty Ltd

Xeomin is now also indicated for the treatment of:

  • Spasticity of upper limb
  • Upper facial lines
    • Lateral periorbital lines (crow's feet)
    • Horizontal forehead lines

DYSPORT

Evaluation commenced: 31 Mar 2017

Registration decision: 2 Mar 2018

Date registered: 13 Mar 2018

Approval time: 194 working days (255)

clostridium botulinum type A toxin - haemagglutinin complex

Ispen Pty Ltd

Dysport is now also indicated for the symptomatic treatment of:

  • focal spasticity affecting the upper limbs in adults.
  • focal spasticity affecting the lower limb in adults.
  • lower limb focal spasticity in children aged 2 years of age or older.

SPRYCEL orphan drug

Evaluation commenced: 28 Feb 2017

Registration decision: 7 Mar 2018

Date registered: 9 Mar 2018

Approval time: 212 working days (255)

dasatinib

Bristol-Myers Squibb Australia Pty Ltd

Sprycel is now also indicated for the treatment of adults aged 18 years or over:

  • with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukaemia in the chronic phase.
  • with chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.
  • with Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.
  • with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.

February 2018

OPDIVO

Evaluation commenced: 31 Jan 2017

Registration decision: 6 Feb 2018

Date registered: 9 Feb 2018

Approval time: 186 working days (255)

nivolumab

Bristol-Myers Squibb Australia Pty Ltd

Opdivo, as monotherapy, is now also indicated for the treatment of patients with locally advanced unresectable or metastatic urothelial carcinoma after prior platinum-containing therapy. The approval of this indication is based on objective response rate and duration of response in a single arm study.

LEFLUNOMIDE GENERICHEALTH

Evaluation commenced: 27 Nov 2017

Registration decision: 1 Feb 2018

Date registered: 6 Feb 2018

Approval time: 44 working days (255)

leflunomide

Southern Cross Pharma Pty Ltd

Generic medicine

LEFLUNOMIDE GENERICHEALTH is now also indicated for the treatment of active psoriatic arthritis. Leflunomide Generichealth is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease. The combined use of Leflunomide Generichealth with other Disease Modifying Anti-Rheumatic Drugs (DMARDs) has not been adequately studied.

RIXADONE

Evaluation commenced: 8 Aug 2017

Registration decision: 30 Jan 2018

Date registered: 5 Feb 2018

Approval time: 124 working days (255)

risperidone

Alphapharm Pty Ltd

Generic medicine

RIXADONE is now also indicated for the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the Alzheimer type.

AFLURIA QUAD

Evaluation commenced: 3 Jan 2017

Registration decision: 1 Feb 2018

Date registered: 2 Feb 2018

Approval time: 200 working days (255)

inactivated quadrivalent influenza vaccine (split virion)

Seqirus Pty Ltd

Afluria Quad is now also indicated for the prevention of influenza caused by Influenza Virus, Types A and B contained in the vaccine, in persons aged 5-17 years.

January 2018

ALECENSA orphan drugpriority review

Evaluation commenced: 7 Sep 2017

Registration decision: 30 Jan 2018

Date registered: 30 Jan 2018

Approval time: 98 working days (255)

alectinib hydrochloride

Roche Products Pty Limited

Alecensa is now also indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC).

VYVANSE

Evaluation commenced: 30 Jun 2016

Registration decision: 22 Jan 2018

Date registered: 24 Jan 2018

Approval time: 242 working days (255)

lisdexamfetamine dimesilate

Shire Australia Pty Ltd

Vyvanse is now also indicated for the treatment of moderate to severe Binge Eating Disorder (BED) in adults when nonpharmacological treatment is unsuccessful or unavailable. Treatment should be commenced and managed by a psychiatrist.

REVLIMID

Evaluation commenced: 31 Mar 2017

Registration decision: 17 Jan 2018

Date registered: 19 Jan 2018

Approval time: 162 working days (255)

lenalidomide

Celgene Pty Ltd

Revlimid is now also indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

EZETIMIBE MSD, ZIENT

Evaluation commenced: 11 Nov 2017

Registration decision: 15 Jan 2018

Date registered: 17 Jan 2018

Approval time: 44 working days (255)

Ezetimibe

Merck Sharp & Dohme (Australia) Pty Ltd

Generic medicine

EZETIMIBE MSD, ZIENT is now also indicated for:

  • Prevention of Cardiovascular Disease

EZETIMIBE MSD, ZIENT is indicated for administration in combination with the maximum tolerated dose of a statin with proven cardiovascular benefit 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.

TRELEGY ELLIPTA

Evaluation commenced: 28 Feb 2017

Registration decision: 9 Jan 2018

Date registered: 16 Jan 2018

Approval time: 192 working days (255)

fluticasone furoate, umeclidinium bromide, vilanterol trifenatate

GlaxoSmithKline Australia Pty Ltd

New conbination

Trelegy Ellipta is now also indicated for the maintenance treatment of adults with moderate to severe chronic obstructive pulmonary disease (COPD) who require treatment with long-acting muscarinic receptor antagonists (LAMA), long-acting β2-adrenergic receptor agonists (LABA), and an inhaled corticosteroid (ICS). Trelegy Ellipta is not indicated for the initiation of therapy in COPD.

ORENCIA

Evaluation commenced: 10 Jan 2017

Registration decision: 10 Jan 2018

Date registered: 12 Jan 2018

Approval time: 208 working days (255)

abatacept (rch)

Bristol-Myers Squibb Australia Pty Ltd

Orencia is now also indicated for the treatment of active psoriatic arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. Orencia can be used with or without non-biologic DMARDs.

KEYTRUDA

Evaluation commenced: 28 Feb 2017

Registration decision: 9 Jan 2018

Date registered: 11 Jan 2018

Approval time: 182 working days (255)

pembrolizumab (rch)

Merck Sharp & Dohme (Australia) Pty Ltd

Keytruda is now also indicated as monotherapy for the treatment of patients with locally advanced or metastatic urothelial carcinoma who:

  • are not eligible for cisplatin-containing therapy. This indication is approved based on overall response rate and duration of response. Improvements in overall survival, progression-free survival, or health-related quality of life have not been established; or
  • have received platinum-containing chemotherapy

VICTOZA

Evaluation commenced: 1 Feb 2017

Registration decision: 5 Jan 2018

Date registered: 8 Jan 2018

Approval time: 193 working days (255)

Liraglutide (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

Victoza is now also indicated for:

  • Glycaemic control: Victoza is indicated as an adjunct to diet and exercise for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control as monotherapy when metformin is contraindicated or is not tolerated.
  • Prevention of cardiovascular events: In patients where Victoza is indicated to improve glycaemic control, Victoza is indicated to reduce the risk of cardiovascular events in those at high cardiovascular risk, as an adjunct to standard of care therapy.

SAXENDA

Evaluation commenced: 1 Feb 2017

Registration decision: 5 Jan 2018

Date registered: 8 Jan 2018

Approval time: 193 working days (255)

liraglutide (rys)

Novo Nordisk Pharmaceuticals Pty Ltd

Saxenda is now also indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

  • ≥ 30 kg/m2 (obese); or
  • ≥ 27 kg/m2 to < 30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

AFINITOR orphan drug

Evaluation commenced: 31 Jan 2017

Registration decision: 22 Dec 2017

Date registered: 3 Jan 2018

Approval time: 182 working days (255)

Everolimus

Novartis Pharmaceuticals Australia Pty Ltd

Afinitor is now also indicated for the adjunctive treatment of patients aged 2 years and older with Tuberous Sclerosis Complex (TSC) and associated refractory seizures.