Prescription medicines: registration of new generic medicines and biosimilar medicines

5 September 2018

Throughout the year, we will be publishing information on new generic and biosimilar prescription medicines as they are approved. Please note that the sponsor name reflects the information in the Australian Register of Therapeutic Goods (ARTG) at the time of registration. As sponsors may change over time, consult the ARTG for full information in relation to these products, including full indications.

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.

Generic medicines

A generic medicine is an additional brand of an existing medicine. It contains the same 'active ingredient' as the existing medicine; the 'active ingredient' is the chemical that is biologically active in the body and makes the medicine work. Active ingredients can be manufactured and sold by other sponsors once the patent for the existing brand medicine has expired.

Apart from containing the same active ingredient, generic medicines must also be 'bioequivalent'. This means that the same amount of active ingredient is absorbed by the body over the same period of time for the same dose of generic or existing medicine.

A 'first generic' medicine is the first registration approved by TGA which permits a sponsor to market a generic drug product in Australia that contains a particular active ingredient. First generics are significant because they have the potential to create more affordable treatment options for patients by triggering a price reduction under the Pharmaceutical Benefits Scheme (PBS). Because the first generic registered by TGA may not necessarily be the first that is PBS listed, please consult the PBS website for further information.

Biosimilar medicines

A biosimilar medicine is a version of a biological medicine that is already registered and is referred to as the 'reference medicine'.

Both the biosimilar medicine and its reference medicine will have similar core characteristics such as physicochemical, biological, immunological, efficacy and safety, which are demonstrated using comprehensive comparability studies. Most biosimilar medicines are likely to contain biotechnology-derived proteins as the active substance.


symbol denoting a first generic

First generic: first TGA approval of a new medicine that contains the same active ingredient as an existing medicine and is bioequivalent to that medicine


Registration of new generic medicines and biosimilar medicines

Previous years

2017

August 2018

ATAZANAVIR MYLAN, ATAZANAVIR ALPHAPHARM

Evaluation commenced: 31 Aug 2015

Registration decision: 13 Sep 2016

Date registered: 28 Aug 2018

Approval time: 218 working days (255)

Atazanavir sulfate

Alphapharm Pty Ltd

New generic medicine

ATAZANAVIR MYLAN, ATAZANAVIR ALPHAPHARM (capsules) is indicated for the treatment of HIV 1 infection, in combination with other antiretroviral agents. This indication is based on analyses of plasma HIV-1 RNA levels and CD4 cell counts from controlled studies.

ANAGRELIDE GPPL, ANAGRELIDE NEO HEALTH, ANAGRELIDE HP, ANAGRELIDE NHPL, ANAGRELIDE APOTEX, ANAGRELIDE NEO orphan drug

Evaluation commenced: 29 Sep 2017

Registration decision: 14 Aug 2018

Date registered: 20 Aug 2018

Approval time: 151 working days (255)

Anagrelide hydrochloride

Neo Health (Australia) Pty Ltd

New generic medicine

ANAGRELIDE GPPL, ANAGRELIDE NEO HEALTH, ANAGRELIDE HP, ANAGRELIDE NHPL, ANAGRELIDE APOTEX, ANAGRELIDE NEO (capsules) is indicated for the treatment of essential thrombocythaemia.

FULPHILA

Evaluation commenced: 3 Jan 2017

Registration decision: 6 Aug 2018

Date registered: 17 Aug 2018

Approval time: 237 working days (255)

Pegfilgrastim

Alphapharm Pty Ltd

New biosimilar medicine

FULPHILA (pre-filled syringe) is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections, as manifested by febrile neutropenia.

LATNOP, LATNOPROS, LATNOPROST, LATNOT

Evaluation commenced: 31 Jul 2017

Registration decision: 7 Aug 2018

Date registered: 16 Aug 2018

Approval time: 169 working days (255)

Latanoprost

Neo Health (Australia) Pty Ltd

New generic medicine

LATNOP, LATNOPROS, LATNOPROST, LATNOT (eye drops) is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

EPLERENONE APOTEX, APO-EPLERENONE

Evaluation commenced: 30 Nov 2017

Registration decision: 2 Aug 2018

Date registered: 8 Aug 2018

Approval time: 144 working days (255)

Eplerenone

Apotex Pty Ltd

New generic medicine

EPLERENONE APOTEX, APO-EPLERENONE (tablets) is indicated to reduce the risk of:

  • cardiovascular death in combination with standard therapy in patients who have evidence of heart failure and left ventricular impairment within 3-14 days of an acute myocardial infarction
  • cardiovascular mortality and morbidity in adult patients with NYHA Class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤ 30% or LVEF ≤ 35% in addition to QRS duration of > 130 msec), in addition to standard optimal therapy.

PANTOPRAZOLE-AFT

Evaluation commenced: 28 Apr 2017

Registration decision: 23 Jul 2018

Date registered: 2 Aug 2018

Approval time: 251 working days (255)

Pantoprazole sodium sesquihydrate

AFT Pharmaceuticals Pty Ltd

New generic medicine

PANTOPRAZOLE-AFT (powder for injection) is indicated for short-term use where oral therapy is not appropriate for:

  1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
    • Duodenal ulcer
    • Gastric ulcer
    • Reflux oesophagitis
    • Gastrointestinal lesions refractory to H2 blockers
    • Zollinger-Ellison Syndrome
  2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.

July 2018

DASATINIB APOTEX, APO-DASATINIB

Evaluation commenced: 30 Jun 2017

Registration decision: 25 Jul 2018

Date registered: 31 Jul 2018

Approval time: 245 working days (255)

Dasatinib

Apotex Pty Ltd

New generic medicine

DASATINIB APOTEX, APO-DASATINIB (tablets) is 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.
  • chronic, accelerated or myeloid or lymphoid blast phase chronic myeloid leukaemia with resistance or intolerance to prior therapy including imatinib.
  • Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.

TEXOTINE, DULOXETINE GXP, DULOXETINE AP, DYBALTINE, DYMBALT, DYBALTINE, DYLOXA

Evaluation commenced: 31 Jul 2017

Registration decision: 23 Jul 2018

Date registered: 31 Jul 2018

Approval time: 204 working days (255)

Duloxetine hydrochloride

Generic Partners Pty Ltd

New generic medicine

TEXOTINE, DULOXETINE GXP, DULOXETINE AP, DYBALTINE, DYMBALT, DYBALTINE, DYLOXA (capsules) is indicated for the treatment of:

  • major depressive disorder (MDD)
  • diabetic peripheral neuropathic pain (DPNP)
  • generalised anxiety disorder (GAD).

ADENOSINE JUNO

Evaluation commenced: 29 Sep 2017

Registration decision: 20 Jul 2018

Date registered: 31 Jul 2018

Approval time: 159 working days (255)

Adenosine

Juno Pharmaceuticals Pty Ltd

New generic medicine

ADENOSINE JUNO (solution for injection) is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging, in patients unable to exercise adequately.

SILDENAFIL-ISPL, SILCAP, SILDENACAP

Evaluation commenced: 31 Aug 2017

Registration decision: 30 Jul 2018

Date registered: 31 Jul 2018

Approval time: 183 working days (255)

Sildenafil citrate

iX Biopharma Pty Ltd

New generic medicine

SILDENAFIL-ISPL, SILCAP, SILDENACAP (capsules) is indicated for the treatment of erectile dysfunction in adult males. Sildenafil is not indicated for use by women.

CABAZITAXEL-DR.REDDY'S, CABAZITAXEL-DRLA, CABAZITAXEL-RZ, CABAZITAXEL-REDDY'S

Evaluation commenced: 4 May 2017

Registration decision: 12 Jul 2018

Date registered: 23 Jul 2018

Approval time: 254 working days (255)

Cabazitaxel

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

CABAZITAXEL-DR.REDDY'S, CABAZITAXEL-DRLA, CABAZITAXEL-RZ, CABAZITAXEL-REDDY'S (injection) in combination with prednisone or prednisolone is indicated for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing regimen.

DORZTIMOLOL, DORZALAMIDE TIMOL, DORZAL TIMO, DORZALAM TIMOLOL

Evaluation commenced: 31 Jul 2017

Registration decision: 25 May 2018

Date registered: 23 Jul 2018

Approval time: 130 working days (255)

Dorzolamide hydrochloride; Timolol maleate

Neo Health (Australia) Pty Ltd

New generic medicine

DORZTIMOLOL, DORZALAMIDE TIMOL, DORZAL TIMO, DORZALAM TIMOLOL (eye drops) is indicated for the treatment of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma when concomitant therapy is appropriate.

HERZUMA, HERTUZU, SIMABTRA

Evaluation commenced: 30 Jun 2017

Registration decision: 5 Jul 2018

Date registered: 17 Jul 2018

Approval time: 212 working days (255)

Trastuzumab

JACE Pharma Pty Ltd

New biosimilar medicine

HERZUMA, HERTUZU, SIMABTRA (powder for injection for intravenous infusion) is indicated for the treatment of patients with:

Early Breast Cancer

HERZUMA is indicated for the treatment of HER2-positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.

Locally Advanced Breast Cancer

HERZUMA is indicated for the treatment of HER2-positive locally advanced breast cancer in combination with neoadjuvant chemotherapy followed by adjuvant HERZUMA.

Metastatic Breast Cancer

HERZUMA is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2:

  1. as monotherapy for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease;
  2. in combination with taxanes for the treatment of those patients who have not received chemotherapy for their metastatic disease; or
  3. in combination with an aromatase inhibitor for the treatment of post-menopausal patients with hormone-receptor positive metastatic breast cancer.
Advanced Gastric Cancer

HERZUMA is indicated in combination with cisplatin and either capecitabine or 5-FU for the treatment of patients with HER2 positive advanced adenocarcinoma of the stomach or gastro- oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.

EPOPROSTENOL SUN first generic

Evaluation commenced: 31 Aug 2017

Registration decision: 3 Jul 2018

Date registered: 13 Jul 2018

Approval time: 168 working days (255)

Epoprostenol sodium

Sun Pharma ANZ Pty Ltd

New generic medicine

EPOPROSTENOL SUN (powder for injection) is indicated for the long-term treatment, via continuous intravenous infusion, in WHO functional Class III or Class IV patients with:

  • Idiopathic pulmonary arterial hypertension
  • Familial pulmonary arterial hypertension
  • Pulmonary arterial hypertension associated with the scleroderma spectrum of diseases.

BIMATOPROST, BIMATOPROST NHPL, BIMATOPROST NEOHEALTH, LUMIPROST, LUMATOGAN, BIMATOLUGAN, BIMATIGAN, LUMITOPROST

Evaluation commenced: 3 Oct 2017

Registration decision: 4 Jul 2018

Date registered: 10 Jul 2018

Approval time: 162 working days (255)

Bimatoprost

Neo Health (Australia) Pty Ltd

New generic medicine

BIMATOPROST, BIMATOPROST NHPL, BIMATOPROST NEOHEALTH, LUMIPROST, LUMATOGAN, BIMATOLUGAN, BIMATIGAN, LUMITOPROST (eye drops) is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

MOXONIDINE LAPL, MOXONIDINE GENERICHEALTH, MOXONIDINE GH

Evaluation commenced: 1 Aug 2017

Registration decision: 29 Jun 2018

Date registered: 9 Jul 2018

Approval time: 150 working days (255)

Moxonidine

Lupin Australia Pty Limited

New generic medicine

MOXONIDINE LAPL, MOXONIDINE GENERICHEALTH, MOXONIDINE GH (tablets) is indicated for the treatment of hypertension.

TIMOEYE, TIMOLOL B&B, TIMOLOL MLPL, TIMOLOL Mlabs

Evaluation commenced: 4 Jul 2017

Registration decision: 18 Jun 2018

Date registered: 3 Jul 2018

Approval time: 156 working days (255)

Timolol maleate

Micro Labs Pty Ltd

New generic medicine

TIMOEYE, TIMOLOL B&B, TIMOLOL MLPL, TIMOLOL Mlabs (eye drops) is indicated for the reduction of elevated intraocular pressure.

June 2018

FLECAINIDE MLabs, FLECAR, FLECAINIDE B&B, FLECAIN

Evaluation commenced: 30 Jun 2017

Registration decision: 31 May 2018

Date registered: 19 Jun 2018

Approval time: 164 working days (255)

Flecainide acetate

Micro Labs Pty Ltd

New generic medicine

FLECAINIDE MLabs, FLECAR, FLECAINIDE B&B, FLECAIN (tablets) are indicated for:

  1. Supraventricular arrhythmias:
    1. due to pre-excitation syndromes, e.g. Wolff-Parkinson-White and Lown- Ganong-Levine syndromes
    2. due to dual AV nodal pathways in patients with debilitating symptoms
    3. paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms

      Although flecainide acetate may be effective in supraventricular arrhythmias in patients with structural heart disease, its use has been associated with life-threatening and occasionally fatal ventricular arrhythmias. In these patients, particularly in the presence of impaired left ventricular function, [TRADE NAME] should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.

      Use of flecainide acetate in chronic atrial fibrillation has not been adequately studied and is not recommended.

  2. Life threatening ventricular arrhythmias not controlled by other drugs.

    Flecainide acetate tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous therapy or conversion by other means.

DORZOTRUS, DORZOSOPT, TRUSOLAMIDE, DORZOLAMIDE NHPL, TRUSOPTIDE, TORZOLAMIDE, DORZOLAMIDE NEOHEALTH

Evaluation commenced: 31 Jul 2017

Registration decision: 25 May 2018

Date registered: 15 Jun 2018

Approval time: 131 working days (255)

Dorzolamide hydrochloride

Neo Health (Australia) Pty Ltd

New generic medicine

DORZOTRUS, DORZOSOPT, TRUSOLAMIDE, DORZOLAMIDE NHPL, TRUSOPTIDE, TORZOLAMIDE, DORZOLAMIDE NEOHEALTH (eye drops) is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma

OLMESART AMLODIPINE GPPL, OLMESART AMLODIPINE, OLMEKAR, OLMESATAN AMLODIPINE GPPL, OLMESATAN AMLO, OLMESART AMLODIPINE

Evaluation commenced: 30 Jun 2017

Registration decision: 7 Jun 2018

Date registered: 13 Jun 2018

Approval time: 188 working days (255)

Amlodipine besilate; Olmesartan medoxomil

Generic Partners Pty Ltd

New generic medicine

OLMESART AMLODIPINE GPPL, OLMESART AMLODIPINE, OLMEKAR, OLMESATAN AMLODIPINE GPPL, OLMESATAN AMLO, OLMESART AMLODIPINE (tablets) is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination.

FLUOROURACIL ACCORD, FLUOROURACIL INTAS

Evaluation commenced: 31 Mar 2017

Registration decision: 5 Jun 2018

Date registered: 8 Jun 2018

Approval time: 253 working days (255)

Fluorouracil

Accord Healthcare Pty Ltd

New generic medicine

FLUOROURACIL ACCORD, FLUOROURACIL INTAS (injection), alone or in combination, is indicated for the treatment for the palliative treatment of malignant tumours, particularly of the breast, colon or rectum; and in the treatment of gastric, primary hepatic, pancreatic, uterine (cervical particularly), ovarian and bladder carcinomas.

TADALAFIL GENERICHEALTH, TADALAFIL LAPL, TADALAFIL GH

Evaluation commenced: 30 Jun 2017

Registration decision: 25 May 2018

Date registered: 7 Jun 2018

Approval time: 171 working days (255)

Tadalafil

Lupin Australia Pty Limited

New generic medicine

TADALAFIL GENERICHEALTH, TADALAFIL LAPL, TADALAFIL GH (tablets) is indicated for the treatment of:

  • erectile dysfunction (ED) in adult males; and
  • moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males.

BPA-PANTOPRAZOLE

Evaluation commenced: 31 Jul 2017

Registration decision: 30 May 2017

Date registered: 7 Jun 2018

Approval time: 167 working days (255)

Pantoprazole (as sodium sesquihydrate)

Beximco Pharmaceuticals Australia Pty Ltd

New generic medicine

BPA-PANTOPRAZOLE (Tablets) is indicated for the treatment of:

Adults
  1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:
    • Duodenal ulcer
    • Gastric ulcer
    • Gastro-oesophageal reflux disease (GORD)
    • Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD
    • Reflux oesophagitis
    • Gastrointestinal lesions refractory to H2 blockers
    • Zollinger-Ellison Syndrome

      Patients whose gastric or duodenal ulceration is not associated with ingestion of non- steroidal anti-inflammatory drugs (NSAIDs) require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.

  2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis
  3. For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics:
    • Clarithromycin and amoxicillin or Clarithomycin and metronidazole or Amoxicillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.
  4. Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of Helicobacter pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism.
  5. Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.
Children aged from 5 to 17 years

Gastro-oesophageal reflux disease (GORD):

  • Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD
  • Reflux oesophagitis

The treatment duration should not exceed 8 weeks.

AKM-PREGABALIN, PHARMACOR PREGABALIN

Evaluation commenced: 29 Apr 2016

Registration decision: 9 May 2018

Date registered: 5 Jun 2018

Approval time: 214 working days (255)

Pregabalin

Pharmacor Pty Ltd

New generic medicine

AKM-PREGABALIN, PHARMACOR PREGABALIN (capsules) is indicated for the treatment of neuropathic pain in adults. Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

May 2018

ERYTHROMYCIN SXP, ERYTHROMYCIN HHH

Evaluation commenced: 28 Jun 2017

Registration decision: 13 Apr 2018

Date registered: 24 May 2018

Approval time: 157 working days (255)

Erythromycin lactobionate

Horizon Hospital Healthcare Pty Ltd

New generic medicine

ERYTHROMYCIN SXP, ERYTHROMYCIN HHH (powder for injection) is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below when oral administration is not possible or when the severity of the infection requires immediate high serum levels of erythromycin. Oral erythromycin is not considered to be the antibiotic of choice in severely ill patients.

  • Upper respiratory tract infections caused by Streptococcus pyogenes (Group A beta-haemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae); Haemophilus influenzae (many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved).
  • Lower respiratory tract infections caused by Streptococcus pyogenes (Group A beta-haemolytic streptococci); Streptococcus pneumoniae (Diplococcus pneumoniae).
  • Respiratory tract infections due to Mycoplasma pneumoniae.
  • Skin and skin structure infections caused by Streptococcus pyogenes and Staphylococcus aureus (resistant staphylococci may emerge during treatment).
  • Diphtheria - As an adjunct to diphtheria antitoxin in infections due to Corynebacterium diphtheriae to prevent establishment of carriers and to eradicate the organism in carriers.
  • Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae: Erythromycin powder for injection (sterile erythromycin lactobionate) followed by erythromycin stearate, base or ethyl succinate orally, as an alternative drug in treatment of acute pelvic inflammatory disease caused by N.gonorrhoeae in female patients with a history of sensitivity to penicillin.
  • Before treatment of gonorrhoea, patients who are suspected of also having syphilis should have microscopic examination for T. pallidum (by immunofluorescence or darkfield) before receiving erythromycin and monthly serologic tests for a minimum of 4 months thereafter.
  • Legionnaires' Disease caused by Legionella pneumophila. Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease.

TENOFOVIR DISOPROXIL/ EMTRICITABINE/ EFAVIRENZ Mylan

Evaluation commenced: 31 Oct 2016

Registration decision: 20 Dec 2017

Date registered: 17 May 2018

Approval time: 200 working days (255)

Tenofovir disoproxil, emtricitabine, efavirenz

Alphapharm Pty Ltd

New generic medicine

TENOFOVIR DISOPROXIL, EMTRICITABINE, EFAVIRENZ Mylan (tablets) is indicated for the treatment of HIV infected adults over the age of 18 years.

AZACIP, AZACITIDINE CA, AZACITIDINE CIPLA

Evaluation commenced: 28 Feb 2017

Registration decision: 1 May 2018

Date registered: 14 May 2018

Approval time: 245 working days (255)

Azacitidine

Cipla Australia Pty Ltd

New generic medicine

AZACIP, AZACITIDINE CA, AZACITIDINE CIPLA (powder for injection) is indicated for the treatment of patients with:

  • Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS),
  • Chronic Myelomonocytic Leukemia [CMMoL (10%-29% marrow blasts without Myeloproliferative Disorder)],
  • Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation (WHO), in whom allogenic stem cell transplantation is not indicated.

ADRENALINE AGUETTANT

Evaluation commenced: 2 Dec 2016

Registration decision: 13 Feb 2018

Date registered: 14 May 2018

Approval time: 169 working days (255)

Adrenaline (epinephrine) as acid tartrate

Juno Pharmaceuticals Pty Ltd

New generic medicine

ADRENALINE AGUETTANT (solution for injection) is indicated as an adjunct in the management of cardiac arrest.

SOLICIP, SOLIFENACIN CIPLA, SOLIFENACIN CPL

Evaluation commenced: 3 May 2017

Registration decision: 3 Apr 2018

Date registered: 3 May 2018

Approval time: 133 working days (255)

Solifenacin succinate

Cipla Australia Pty Ltd

New generic medicine

SOLICIP, SOLIFENACIN CIPLA, SOLIFENACIN CPL (tablets) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

April 2018

FENOCIPLA; FENOFIBRATE CIPLA; FENOCOL

Evaluation commenced: 3 May 2017

Registration decision: 22 Feb 2018

Date registered: 30 Apr 2018

Approval time: 144 working days (255)

Fenofibrate

Cipla Australia Pty Ltd

New generic medicine

FENOCIPLA, FENOFIBRATE CIPLA, FENOCOL (tablets) is indicated as an adjunct to diet in the treatment of:

  • Hypercholesterolaemia;
  • Types II, III, IV and V dyslipidaemia;
  • Dyslipidaemia associated with type 2 diabetes.

OLMESARTAN AMLO HCT GPPL; OLMESART AMLO HCT; OLMEKAR HCT; OLMES AMLO HCT; OLMETAN AMLO HCT

Evaluation commenced: 31 May 2017

Registration decision: 17 Apr 2018

Date registered: 23 Apr 2018

Approval time: 176 working days (255)

Olmesartan medoxomil; Hydrochlorothiazide; amlodipine besilate

Generic Partners Pty Ltd

New generic medicine

OLMESARTAN AMLO HCT GPPL, OLMESART AMLO HCT, OLMEKAR HCT, OLMES AMLO HCT, OLMETAN AMLO HCT (tablets) is indicated for the treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination.This fixed dose combination is not indicated for initial therapy.

RITEMVIA; TRUXIMA

Evaluation commenced: 31 Mar 2017

Registration decision: 13 Mar 2018

Date registered: 16 Apr 2018

Approval time: 199 working days (255)

Rituximab

Pharmbio Pty Ltd

New biosimilar medicine

RITEMVIA, TRUXIMA (solution for intravenous infusion) is indicated:

  • for treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy;
  • for treatment of patients with methotrexate is indicated for the treatment of adult patients with severe, active rheumatoid arthritis who have had an inadequate response or intolerance to at least one tumour necrosis factor (TNF) inhibitor therapy;
  • in combination with glucocorticoids is indicated for the induction of remission in patients with severely active Granulomatosis with polyangiitis (GPA, also known as Wegener's granulomatosis) and Microscopic polyangiitis (MPA).

BORTEZOMIB-REDDY'S; BORTEZOMIB-DRLA; BORTEZOMIB-RZ

Evaluation commenced: 3 Jan 2017

Registration decision: 8 Mar 2018

Date registered: 13 Apr 2018

Approval time: 253 working days (255)

Bortezomib

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

BORTEZOMIB-REDDY'S, BORTEZOMIB-DRLA, BORTEZOMIB-RZ (for injection) is indicated:

  • in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy.
  • as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma.
  • is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.
  • in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

BORTEZOMIB JUNO, BORTEZOMIB JN

Evaluation commenced: 3 Jan 2017

Registration decision: 9 Mar 2018

Date registered: 12 Apr 2018

Approval time: 254 working days (255)

Bortezomib

Juno Pharmaceuticals Pty Ltd

New generic medicine

BORTEZOMIB JUNO, BORTEZOMIB JN (powder for injection) is indicated for:

  • in combination with melphalan and prednisone, the treatment of patients with previously untreated multiple myeloma who are not candidates for high dose chemotherapy;
  • as part of combination therapy, for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma;
  • the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease; and
  • in combination with rituximab, cyclophosphamide, doxorubicin and prednisone, for the treatment of adult patients with previously untreated mantle cell lymphoma.

AKM SOLIFENACIN, PHARMACOR SOLIFENACIN

Evaluation commenced: 30 May 2017

Registration decision: 19 Mar 2017

Date registered: 10 Apr 2018

Approval time: 161 working days (255)

Solifenacin succinate

Pharmacor Pty Ltd

New generic medicine

AKM SOLIFENACIN, PHARMACOR SOLIFENACIN (tablets) is indicated for the treatment of overactive bladder with symptons of urge urinary incontinence, urgency or increased urinary frequency.

PARECOXB, PARECOX, PARECOXIB JPL, PARECOXIB-APOTEX first generic

Evaluation commenced: 30 Nov 2016

Registration decision: 13 Oct 2017

Date registered: 4 Apr 2018

Approval time: 217 working days (255)

Parecoxib sodium

Neo Health (Australia) Pty Ltd

New generic medicine

PARECOXB, PARECOX, PARECOXIB JPL, PARECOXIB-APOTEX (powder for injection) is indicated for a single per-operative dose for the management of post-operative pain.

MEBEVERINE GPPL, MEBEVERINE GXP, CMEBEVERINE, COLOBEVERINE, COLOVERINE, CVERINE, MEBERINE

Evaluation commenced: 31 May 2017

Registration decision: 28 Mar 2018

Date registered: 3 Apr 2018

Approval time: 167 working days (255)

Mebeverine hydrochloride

Generic Partners Pty Ltd

New generic medicine

MEBEVERINE GPPL, MEBEVERINE GXP, CMEBEVERINE, COLOBEVERINE, COLOVERINE, CVERINE, MEBERINE (tablets) is indicated in the management of the irritable bowel syndrome ('irritable colon', 'spastic colon', functional bowel disorders', spastic constipation', 'nervous diarrhoea'). Mebeverine hydrochloride is used to treat the symptoms of this condition - i.e. abdominal pain and cramps, persistent, non-specific diarrhoea (with or without alternating constipation) and flatulence.

TIBOLONE RMB, TIBOLONE SANDOZ, TIBOLONE SCP

Evaluation commenced: 31 Mar 2017

Registration decision: 20 Mar 2018

Date registered: 3 Apr 2018

Approval time: 175 working days (255)

tibolone

Southern Cross Pharma Pty Ltd

New generic medicine

TIBOLONE RMB, TIBOLONE SANDOZ, TIBOLONE SCP (tablets) is indicated for:

  • Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.
  • Second line of therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.

EMPOVIR

Evaluation commenced: 28 Apr 2017

Registration decision: 13 Mar 2018

Date registered: 3 Apr 2018

Approval time: 171 working days (255)

cidofovir

Emcure Pharmaceuticals Pty Ltd

New generic medicine

EMPOVIR (concentrated injection) is indicated in adults for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS).

CAMDIS, AMLODIPINE/ATORVASTATIN-AS, AMLODIPINE/ATORVASTATIN-GX, AMLODIPINE/ATORVASTATIN-MEDIS

Evaluation commenced: 4 Jan 2016

Registration decision: 12 Jul 2017

Date registered: 2 Apr 2018

Approval time: 254 working days (255)

amlodipine(as besilate); atorvastatin(as calcium)

Medis Pharma Pty Ltd

New generic medicine

CAMDIS, AMLODIPINE/ATORVASTATIN-AS, AMLODIPINE/ATORVASTATIN-GX, AMLODIPINE/ATORVASTATIN-MEDIS (tablets) is indicated for patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.

The indications for amlodipine are:

  1. Hypertension: Amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta adrenoceptor blocking agent or an angiotensin converting enzyme inhibitor.
  2. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs.

The indications for atorvastatin are:

  1. Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.

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

  2. Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see CLINICAL TRIALS, Prevention of Cardiovascular Disease) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.

These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

March 2018

SEMGLEE

Evaluation commenced: 31 Mar 2017

Registration decision: 21 Mar 2018

Date registered: 28 Mar 2018

Approval time: 200 working days (255)

insulin glargine

Alphapharm Pty Ltd

New biosimilar medicine

SEMGLEE (solution for injection) is indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for the control of hyperglycaemia.

TIBOLON, LIVILAN, TIBOLONE GENPAR, TIBOLONE GPPL, APO-TIBOLONE, TERRY WHITE CHEMISTS TIBOLONE, CHEMMART TIBOLONE

Evaluation commenced: 2 Dec 2016

Registration decision: 19 Mar 2018

Date registered: 28 Mar 2018

Approval time: 253 working days (255)

tibolone

Generic Partners Pty Ltd

New generic medicine

Tibolone tablets is indicated for:

  • Short-term treatment of symptoms resulting from the natural or surgical menopause in postmenopausal women.
  • Second line of therapy for the prevention of bone mineral density loss in postmenopausal women at high risk of future osteoporotic fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of bone mineral density loss.

APO-VARDENAFIL, VARDENAFIL APOTEX

Evaluation commenced: 30 Jun 2017

Registration decision: 20 Mar 2018

Date registered: 26 Mar 2018

Approval time: 162 working days (255)

vardenafil (as hydrochloride trihydrate)

Apotex Pty Ltd

New generic medicine

APO-VARDENAFIL, VARDENAFIL APOTEX (tablets) is indicated for the treatment of erectile dysfunction in adult male (inability to achieve or maintain penile erection sufficient for sexual performance). Vardenafil is not indicated for use by women.

MELPHA

Evaluation commenced: 3 May 2017

Registration decision: 21 Feb 2018

Date registered: 15 Mar 2018

Approval time: 166 working days (255)

melphalan (as hydrochloride)

Pharmatech Pty Ltd

New generic medicine

MELPHA (injection) is indicated for the treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

CIP LATANOPROST, LATANOPROST CIP, LATANOPROST CA

Evaluation commenced: 30 Nov 2016

Registration decision: 21 Feb 2018

Date registered: 14 Mar 2018

Approval time: 115 working days (255)

latanoprost

Cipla Australia Pty Ltd

New generic medicine

CIP LATANOPROST/LATANOPROST CIP/LATANOPROST CA (eye drops) is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

BIMATOPROST JNO, BIMATOPROST JUNO, BIMPROZT, BIMATOPROST JN

Evaluation commenced: 31 May 2017

Registration decision: 21 Feb 2018

Date registered: 14 Mar 2018

Approval time: 115 working days (255)

bimatoprost

Juno Pharmaceuticals Pty Ltd

New generic medicine

BIMATOPROST JNO/BIMATOPROST JUNO/BIMPROZT/BIMATOPROST JN (eye drops) is indicated for the reduction of elevated intraocular pressure, or open angle glaucoma, as first line therapy or monotherapy or as adjunctive therapy to topical beta-blockers.

APOMORPHINE WOCKHARDT, APOWOK

Evaluation commenced: 31 May 2017

Registration decision: 8 Mar 2018

Date registered: 14 Mar 2018

Approval time: 176 working days (255)

apomorphine hydrochloride hemihydrate

Wockhardt Bio Pty Ltd

New generic medicine

APOMORPHINE WOCKHARDT/APOWOK (solution for injection or infusion) is indicated to reduce the number and severity of "off" phases in patients with Parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy.

ADENOSINE-CLARIS, ADSINE

Evaluation commenced: 28 Feb 2017

Registration decision: 19 Dec 2017

Date registered: 7 Mar 2018

Approval time: 141 working days (255)

adenosine

AFT Pharmaceuticals Pty Ltd

New generic medicine

Adenosine 30 mg/10 mL solution for infusion is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging in patients unable to exercise adequately.

Adenosine 6 mg/2 mL solution for injection is indicated for:

  • Therapeutic indications:
    • Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White syndrome).
  • Diagnostic indications:
    • Aid to diagnosis of broad or narrow QRS complex supraventricular tachycardias. Although adenosine 6 mg/2 mL is not effective in converting atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction helps diagnosis of atrial activity;
    • In this respect, adenosine should be used as an adjunct to, but not a replacement for, clinical and ECG observations. It should be used only when, despite all diagnostic attempts, doubt still persists;
    • Improved diagnostic sensitivity of intracavity electrophysiological investigations.

TADALAFIL-RZ, TADALAFIL-DRLA, TADALAFIL-DR.REDDY'S, TADALAFIL-REDDY'S

Evaluation commenced: 28 Feb 2017

Registration decision: 22 Feb 2018

Date registered: 2 Mar 2018

Approval time: 202 working days (255)

tadalafil

Dr Reddy's Laboratories (Australia) Pty Ltd

New generic medicine

TADALAFIL-RZ, TADALAFIL-DRLA, TADALAFIL-DR.REDDY'S, TADALAFIL-REDDY'S (tablets) is indicated for the treatment of:

  • Erectile dysfunction (ED) in adult males;
  • Moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males.

Tadalafil 10 mg and 20 mg film-coated tablets are indicated for the treatment of:

  • Erectile dysfunction (ED) in adult males.

PEN G SANDOZ

Evaluation commenced: 31 Mar 2017

Registration decision: 5 Feb 2018

Date registered: 1 Mar 2018

Approval time: 173 working days (255)

benzylpenicillin sodium

Sandoz Pty Ltd

New generic medicine

PEN G SANDOZ (powder for injection) is indicated for the treatment of infections caused by benzylpenicillin sensitive organisms. These include Streptococcus pyogenes and most other Gram-positive organisms. It is also indicated for the treatment of syphilis. Pen G Sandoz may also be used for the prevention of bacterial endocarditis in dental and upper respiratory tract procedures and prevention of wound infections and sepsis in surgical procedures where Streptococci are the likely pathogens.

February 2018

TOBRAMYCIN WKT, TOBRAMYCIN WOCKHARDT

Evaluation commenced: 29 Sep 2016

Registration decision: 19 Feb 2018

Date registered: 23 Feb 2018

Approval time: 180 working days (255)

tobramycin

Wockhardt Bio Pty Ltd

New generic medicine

TOBRAMYCIN WKT, TOBRAMYCIN WOCKHARDT (solution for inhalation) is indicated for the management of cystic fibrosis patients with P. aeruginosa infections. Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 ≤ 25% or ≥ 80% predicted at screening, or patients colonised with Burkholderia cepacia.

APO-TRAMADOL/ PARACETAMOL, TRAMADOL / PARACETAMOL

Evaluation commenced: 31 Oct 2016

Registration decision: 8 Feb 2018

Date registered: 22 Feb 2018

Approval time: 200 working days (255)

tramadol hydrochloride / paracetamol

Apotex Pty Ltd

New generic medicine

APO-TRAMADOL /PARACETAMOL, TRAMADOL /PARACETAMOL (tablets) is indicated for the treatment of moderate pain.

APO-NEBIVOLOL, NEBIVOLOL APOTEX

Evaluation commenced: 28 Nov 2016

Registration decision: 13 Feb 2018

Date registered: 21 Feb 2018

Approval time: 143 working days (255)

nebivolol (as hydrochloride)

Apotex Pty Ltd

New generic medicine

APO-NEBIVOLOL, NEBIVOLOL APOTEX (tablets) is indicated for the treatment of:

  • essential hypertension;
  • stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older.

AMIWOK, AMIKACIN WOCKHARDT

Evaluation commenced: 31 May 2017

Registration decision: 8 Feb 2018

Date registered: 14 Feb 2018

Approval time: 151 working days (255)

amikacin (as sulfate)

Wockhardt Bio Pty Ltd

New generic medicine

AMIWOK, AMIKACIN WOCKHARDT (solution for injection) is indicated in the:

  • short-term treatment of serious infections caused by susceptible strains of Gram-negative bacteria;
  • treatment of neonatal sepsis when sensitivity testing indicates that other aminoglycosides cannot be used.

OLMESARTAN GxP, OLMESARTAN GPPL, OLMES, OLMESART

Evaluation commenced: 3 May 2017

Registration decision: 23 Jan 2018

Date registered: 2 Feb 2018

Approval time: 138 working days (255)

olmesartan medoxomil

Generic Partners Pty Ltd

New generic medicine

OLMESARTAN GxP, OLMESARTAN GPPL, OLMES, OLMESART (tablets) is indicated for the treatment of hypertension.

OLMESARTAN MEDOXOMIL HCTZ GP, OLMESARTAN HCT GPPL, OLMESART HCT GXP, OLMESART HCT

Evaluation commenced: 3 May 2017

Registration decision: 23 Jan 2018

Date registered: 2 Feb 2018

Approval time: 142 working days (255)

olmesartan medoxomil & hydrochlorothiazide

Generic Partners Pty Ltd

New generic medicine

OLMESARTAN MEDOXOMIL HCTZ GP, OLMESARTAN HCT GPPL, OLMESART HCT GXP, OLMESART HCT (tablets) is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

January 2018

AKM-OLMESARTAN HCTZ, ALKEM OLMESARTAN HCTZ, PHARMACOR OLMESARTAN HCTZ

Evaluation commenced: 31 Mar 2017

Registration decision: 12 Jan 2018

Date registered: 29 Jan 2018

Approval time: 176 working days (255)

olmesartan medoxomil and hydrochlorothiazide

Pharmacor Pty Ltd

New generic medicine

AKM-OLMESARTAN HCTZ, ALKEM OLMESARTAN HCTZ, PHARMACOR OLMESARTAN HCTZ (tablets) is indicated for the treatment of hypertension. Treatment should not be initiated with this fixed dose combination.

HADLIMA

Evaluation commenced: 3 Jan 2017

Registration decision: 18 Jan 2018

Date registered: 24 Jan 2018

Approval time: 214 working days (255)

adalimumab (rch)

Samsung Bioepis AU Pty Ltd

New biosimilar medicine

HADLIMA (injection) solution is indicated for reducing signs and symptoms, as well as inhibiting the progression of structural damage in adult patients with moderate to severely active rheumatoid arthritis (RA).

AZALINE, AZIGILINE, ASAGILINE, RASAZILECT, RASAGILINE MYLAN, RASAGILINE GPPL, RASAGILINE GXP first generic

Evaluation commenced: 28 Feb 2017

Registration decision: 11 Jan 2018

Date registered: 23 Jan 2018

Approval time: 174 working days (255)

rasagiline mesilate

Generic Partners Pty Ltd

New generic medicine

AZALINE, AZIGILINE, ASAGILINE, RASAZILECT, RASAGILINE MYLAN, RASAGILINE GPPL, RASAGILINE GXP (tablets) is indicated for the symptomatic treatment of idiopathic Parkinson's disease (PD) as monotherapy (without concomitant levodopa , decarboxylase inhibitor therapy) or as adjunct therapy (with concomitant levodopa , decarboxylase inhibitor therapy).

METARAMINOL PHEBRA, ARAMINE first generic

Evaluation commenced: 31 Mar 2017

Registration decision: 8 Dec 2017

Date registered: 16 Jan 2018

Approval time: 129 working days (255)

metaraminol (as tartrate)

Phebra Pty Ltd

New generic medicine

METARAMINOL PHEBRA, ARAMINE (injections) is indicated for the prevention and treatment of the acute hypotensive state occurring with spinal anaesthesia; adjunctive treatment of hypotension due to haemorrhage, reactions to medications, surgical complications, and shock associated with brain damage due to tumour or trauma. They may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.

MOXONIDINE SCP, MOXONIDINE TLB, APO-MOXONIDINE, MOXONIDINE RMB, MOXONIDINE AJS, MOXONIDINE SANDOZ first generic

Evaluation commenced: 28 Feb 2017

Registration decision: 15 Dec 2017

Date registered: 16 Jan 2018

Approval time: 157 working days (255)

moxonidine

Southern Cross Pharma Pty Ltd

New generic medicine

MOXONIDINE SCP, MOXONIDINE TLB, APO-MOXONIDINE, MOXONIDINE RMB, MOXONIDINE AJS, MOXONIDINE SANDOZ (tablets) is indicated for the treatment of hypertension.

TADALAFIL INTAS, TADALACCORD, TADALAFIL AN, TADALAFIL ASTRON, TADALAFIL AMEDA, TADALAFIL SANDOZ, TADALCA, TADALAFIL AN PHT

Evaluation commenced: 28 Nov 2016

Registration decision: 11 Dec 2017

Date registered: 15 Jan 2018

Approval time: 123 working days (255)

tadalafil

Accord Healthcare Pty Ltd

New generic medicine

TADALAFIL INTAS, TADALACCORD, TADALAFIL AN, TADALAFIL ASTRON, TADALAFIL AMEDA, TADALAFIL SANDOZ

Tadalafil (tablets) is indicated for the treatment of:

  • erectile dysfunction (ED) in adult males;
  • moderate to severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in adult males.
TADALCA/TADALAFIL AN PHT

Tadalafil (tablets) is indicated for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in idiopathic PAH (IPAH) and in PAH related to collagen vascular disease.

CASPOCIP, CASPOFUNGIN CA, CASPOFUNGIN CIPLA

Evaluation commenced: 3 Jan 2017

Registration decision: 1 Dec 2017

Date registered: 12 Jan 2018

Approval time: 189 working days (255)

caspofungin (as acetate)

Cipla Australia Pty Ltd

New generic medicine

CASPOCIP/CASPOFUNGIN CA/CASPOFUNGIN CIPLA (powder for injection) is indicated for the treatment of presumed fungal infections in febrile, neutropenic patients whose fever has failed to respond to broad-spectrum antibiotics. It is indicated for the treatment of invasive candidiasis, including candidaemia; oesophageal candidiasis; and invasive aspergillosis in patients who are refractory to, or intolerant of, other therapies.

IVABRADINE GPPL, IVABRADINE GXP, COBADINE, APO-IVABRADINE, CORALIVAN, CIVABRADINE, IVABRADINE NHPL

Evaluation commenced: 28 Feb 2017

Registration decision: 2 Jan 2018

Date registered: 11 Jan 2018

Approval time: 166 working days (255)

ivabradine (as hydrochloride)

Generic Partners Pty Ltd

New generic medicine

IVABRADINE GPPL, IVABRADINE GXP, COBADINE, APO-IVABRADINE, CORALIVAN, CIVABRADINE, IVABRADINE NHPL (tablets) is indicated for the treatment of chronic stable angina and chronic heart failure.

CLARISCAN first generic

Evaluation commenced: 28 Feb 2017

Registration decision: 19 Dec 2017

Date registered: 11 Jan 2018

Approval time: 161 working days (255)

gadoteric acid

GE Healthcare Australia Pty Ltd

New generic medicine

CLARISCAN (solution for injection) is indicated, in adults and children, for use with magnetic resonance imaging to provide contrast enhancement for intracranial and spinal lesions with abnormal blood brain barrier or abnormal vascularity, and for whole body imaging.

LENCADOPA, LEVOCARBAMET, LEVODOPA/CARBIDOPA GPPL, LEVOCARBAMET, LEVODOPA/CARBIDOPA GXP, APO-LEVODOPA/CARBIDOPA, LEVODOPA/CARBIDOPA GENPAR

Evaluation commenced: 30 Jun 2016

Registration decision: 5 Jan 2018

Date registered: 11 Jan 2018

Approval time: 232 working days (255)

levodopa / carbidopa

Generic Partners Pty Ltd

New generic medicine

Levodopa , carbidopa (tablets) are indicated for the treatment of Parkinson's disease and syndrome.

BOSENTAN CIPLA, BOSENTAS, BOSENCIP

Evaluation commenced: 31 Jan 2017

Registration decision: 7 Dec 2017

Date registered: 3 Jan 2018

Approval time: 165 working days (255)

Bosentan (as monohydrate)

Cipla Australia Pty Ltd

New generic medicine

BOSENTAN CIPLA, BOSENTAS, BOSENCIP (tablets) is indicated for the treatment of:

  • idiopathic pulmonary arterial hypertension;
  • familial pulmonary arterial hypertension;
  • pulmonary arterial hypertension associated with scleroderma; or
  • pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology

in patients with WHO functional Class II, III or IV symptoms.