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Prescription medicines: registration of new generic medicines and biosimilar medicines

6 October 2020

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, 2020

Previous years

2019 2018 2017

September 2020

HYOSCINE BUTYLBROMIDE MEDSURGE, HYOSCINE BUTYLBROMIDE MEDICIANZ

Evaluation commenced: 2 Jan 2020

Registration decision: 23 Sep 2020

Date registered: 29 Sep 2020

Approval time: 152 working days (255)

hyoscine butylbromide

Medicianz Healthcare Pty Ltd

New generic medicine

HYOSCINE BUTYLBROMIDE MEDSURGE, HYOSCINE BUTYLBROMIDE MEDICIANZ (solution for injection) is indicated for the treatment of spasm of the gastrointestinal tract, biliary spasm, renal spasm, and as a diagnostic aid in radiology.

ALEMBIC ARIPIPRAZOLE, ARILEM ARIPIPRAZOLE, ARILEMBIC ARIPIPRAZOLE, ARIPIC ARIPIPRAZOLE, ARIPIPRAZOLE AGH, ARIPIPRAZOLE AGHL, ARIPIPRAZOLE APL, ARIPIPRAZOLE APPL, ARIPITO ARIPIPRAZOLE, ARITRIEVAL ARIPIPRAZOLE, ARIVEL ARIPIPRAZOLE, PIVELON ARIPIPRAZOLE

Evaluation commenced: 2 Dec 2019

Registration decision: 3 Sep 2020

Date registered: 23 Sep 2020

Approval time: 154 working days (255)

aripiprazole

Alembic Pharmaceuticals Australia Pty Ltd

New generic medicine

ALEMBIC ARIPIPRAZOLE, ARILEM ARIPIPRAZOLE, ARILEMBIC ARIPIPRAZOLE, ARIPIC ARIPIPRAZOLE, ARIPIPRAZOLE AGH, ARIPIPRAZOLE AGHL, ARIPIPRAZOLE APL, ARIPIPRAZOLE APPL, ARIPITO ARIPIPRAZOLE, ARITRIEVAL ARIPIPRAZOLE, ARIVEL ARIPIPRAZOLE, PIVELON ARIPIPRAZOLE (uncoated tablet) is indicated for the treatment of:

  • Schizophrenia including maintenance of clinical improvement during continuation therapy.
  • Acute treatment of manic or mixed episodes associated with Bipolar I Disorder in adults as monotherapy and in combination with lithium or valproate;
  • Maintenance treatment of manic or mixed episodes in Bipolar I Disorder in adults as monotherapy.

BENDAMUSTINE GEN, BENDAMUSTINE JUNO, BENDAMUSTINE LU first generic

Evaluation commenced: 31 Oct 2019

Registration decision: 21 Sep 2020

Date registered: 23 Sep 2020

Approval time: 136 working days (255)

bendamustine hydrochloride

Luminarie Pty Ltd

New generic medicine

BENDAMUSTINE GEN, BENDAMUSTINE JUNO, BENDAMUSTINE LU (powder for injection) is indicated for:

  • First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). Efficacy relative to first-line therapies other than chlorambucil has not been established.
  • Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin's lymphoma, in combination with rituximab.
  • Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patient's ineligible for autologous stem cell transplantation.
  • Relapsed/Refractory indolent Non-Hodgkin's lymphoma.

XOROX orphan drug

Evaluation commenced: 31 Jul 2019

Registration decision: 15 Sep 2020

Date registered: 21 Sep 2020

Approval time: 172 working days (255)

aciclovir

Agepha Pharma Pty Ltd

New generic medicine

XOROX (eye ointment) is indicated for the treatment of herpes Simplex keratitis.

CABAZITAXEL-TEVA

Evaluation commenced: 3 Jun 2019

Registration decision: 14 Aug 2020

Date registered: 16 Sep 2020

Approval time: 253 working days (255)

cabazitaxel ethyl acetate solvate

Teva Pharma Australia Pty Ltd

New generic medicine

CABAZITAXEL-TEVA (concentrated solution for 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.

PREGABALIN-AFT

Evaluation commenced: 2 Dec 2019

Registration decision: 11 Sep 2020

Date registered: 16 Sep 2020

Approval time: 157 working days (255)

pregabalin

AFT Pharmaceuticals Pty Ltd

New generic medicine

PREGABALIN-AFT (oral solution) is indicated for the treatment of neuropathic pain in adults.

PREGABALIN-AFT is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

BELLA ETHINYLOESTRADIOL/DROPIRENONE, ETHINYLOESTRADIOL/DROPIRENONE GENERIC HEALTH, ETHINYLOESTRADIOL/DROPIRENONE GH, ETHINYLOESTRADIOL/DROPIRENONE LAPL, ETHINYLOESTRADIOL/DROPIRENONE LL, ETHINYLOESTRADIOL/DROPIRENONE LUPIN first generic

Evaluation commenced: 10 May 2012

Registration decision: 22 Aug 2013

Date registered: 11 Sep 2020

Approval time: 230 working days (255)

ethinyloestradiol, drospirenone

Lupin Australia Pty Limited

New generic medicine

BELLA ETHINYLOESTRADIOL/DROPIRENONE, ETHINYLOESTRADIOL/DROPIRENONE GENERIC HEALTH, ETHINYLOESTRADIOL/DROPIRENONE GH, ETHINYLOESTRADIOL/DROPIRENONE LAPL, ETHINYLOESTRADIOL/DROPIRENONE LL, ETHINYLOESTRADIOL/DROPIRENONE LUPIN (film coated tablet) is indicated for use as:

  • an oral contraceptive.
  • treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of ethinylestradiol/drospirenone tablet for PMDD was not assessed beyond 3 cycles. Ethinylestradiol/ drospirenone tablet has not been evaluated for treatment of PMS (premenstrual syndrome).

AKM DEFERASIROX, PHARMACOR DEFERASIROX

Evaluation commenced: 29 Jun 2018

Registration decision: 27 Aug 2019

Date registered: 9 Sep 2020

Approval time: 250 working days (255)

deferasirox

Pharmacor Pty Ltd

New generic medicine

AKM DEFERASIROX, PHARMACOR DEFERASIROX (dispersible tablet) is indicated in the treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older.

Deferasirox is also indicated for the treatment of chronic iron overload in paediatric patients aged 2 to 5 years who are unable to take desferrioxamine therapy or in whom desferrioxamine has proven ineffective.

Deferasirox is also indicated for the treatment of chronic iron overload in patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.

FINGOLIMOD RAN, FINGOLIMOD RBX, FINGOLIMOD SUN

Evaluation commenced: 5 Jun 2019

Registration decision: 2 Sep 2020

Date registered: 9 Sep 2020

Approval time: 215 working days (255)

fingolimod hydrochloride

Sun Pharma ANZ Pty Ltd

New generic medicine

FINGOLIMOD RAN, FINGOLIMOD RBX, FINGOLIMOD SUN (capsule) is indicated for the treatment of adult and paediatric patients of 10 years of age and above with relapsing forms of multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

August 2020

MSN CABAZITAXEL

Evaluation commenced: 6 May 2019

Registration decision: 21 Aug 2020

Date registered: 26 Aug 2020

Approval time: 151 working days (255)

cabazitaxel

Accelagen Pty Ltd

New generic medicine

MSN CABAZITAXEL (concentrated injection vial, diluent vial) 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.

FENOCIPLA, FENOCOL, FENOFIBRATE CIPLA

Evaluation commenced: 31 Oct 2019

Registration decision: 27 Jul 2020

Date registered: 21 Aug 2020

Approval time: 156 working days (255)

fenofibrate

Cipla Australia Pty Ltd

New generic medicine

FENOCIPLA, FENOCOL, FENOFIBRATE CIPLA (tablet) 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.

AKM FINGOLIMOD, PHARMACOR FINGOLIMOD

Evaluation commenced: 29 Jun 2018

Registration decision: 13 Aug 2019

Date registered: 18 Aug 2020

Approval time: 232 working days (255)

fingolimod hydrochloride

Pharmacor Pty Ltd

New generic medicine

AKM FINGOLIMOD, PHARMACOR FINGOLIMOD (capsule) is indicated for the treatment of Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with superimposed relapses to delay the progression of physical disability and reduce the frequency of relapse.

ERLOTINIB APOTEX first generic

Evaluation commenced: 31 Oct 2019

Registration decision: 6 Aug 2020

Date registered: 12 Aug 2020

Approval time: 145 working days (255)

erlotinib hydrochloride

Accelagen Pty Ltd

New generic medicine

Non-Small Cell Lung Cancer

ERLOTINIB APOTEX (film coated tablet) is indicated for the first-line treatment of patients with advanced (Stage IIIB) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) with activating EGFR mutations.

ERLOTINIB APOTEX is indicated for maintenance therapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating EGFR mutations who have not progressed on first-line chemotherapy.

ERLOTINIB APOTEX is also indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of prior chemotherapy.

Pancreatic cancer

ERLOTINIB APOTEX in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.

PLERIXAFOR APOTEX first generic

Evaluation commenced: 8 Aug 2019

Registration decision: 31 Jul 2020

Date registered: 12 Aug 2020

Approval time: 202 working days (255)

plerixafor

Accelagen Pty Ltd

New generic medicine

PLERIXAFOR APOTEX (solution for injection) is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to mobilise haematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma (MM).

CARMUSTINE DR REDDY'S, CARMUSTINE-DRLA, CARMUSTINE-JUNO, REDDY'S-CARMUSTINE first generic

Evaluation commenced: 31 Jul 2019

Registration decision: 14 May 2020

Date registered: 12 Aug 2020

Approval time: 154 working days (255)

carmustine

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

CARMUSTINE DR REDDY'S, CARMUSTINE-DRLA, CARMUSTINE-JUNO, REDDY'S-CARMUSTINE (powder for injection) is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

  • Malignant Glioma
  • Multiple Myeloma - in combination with prednisone.
  • Hodgkin's Disease - as secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
  • Non-Hodgkin's lymphomas - as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

POSACONAZOLE JUNO, POSCOLE

Evaluation commenced: 2 Dec 2019

Registration decision: 4 Aug 2020

Date registered: 7 Aug 2020

Approval time: 144 working days (255)

posaconazole

Juno Pharmaceuticals Pty Ltd

New generic medicine

POSACONAZOLE JUNO, POSCOLE (modified release tablet) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:

  • Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.
  • Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.

POSACONAZOLE JUNO, POSCOLE is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

July 2020

GENRX TAMOXIFEN, TAMOXIFEN AJS, TAMOXIFEN SCP

Evaluation commenced: 6 May 2019

Registration decision: 20 Jul 2020

Date registered: 24 Jul 2020

Approval time: 210 working days (255)

tamoxifen citrate

Southern Cross Pharma Pty Ltd

New generic medicine

Treatment of breast cancer

GENRX TAMOXIFEN, TAMOXIFEN AJS, TAMOXIFEN SCP (tablets) are indicated for the treatment of breast cancer.

Primary reduction of breast cancer risk

GENRX TAMOXIFEN, TAMOXIFEN AJS, TAMOXIFEN SCP are indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

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

Evaluation commenced: 31 May 2019

Registration decision: 19 Mar 2020

Date registered: 24 Jul 2020

Approval time: 161 working days (255)

posaconazole

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

POSACONAZOLE DR.REDDY'S, POSACONAZOLE-DRLA, POSACONAZOLE-REDDY'S, POSACONAZOLE-RZ (modified release tablet) are indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:

  • Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.
  • Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.

POSACONAZOLE DR.REDDY'S, POSACONAZOLE-DRLA, POSACONAZOLE-REDDY'S, POSACONAZOLE-RZ is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

OXYCODONE MEDICIANZ, OXYCODONE MEDSURGE

Evaluation commenced: 31 Oct 2019

Registration decision: 16 Jul 2020

Date registered: 23 Jul 2020

Approval time: 133 working days (255)

oxycodone hydrochloride

Medicianz Healthcare Pty Ltd

New generic medicine

OXYCODONE MEDICIANZ, OXYCODONE MEDSURGE (solution for injection) is indicated for the management of opioid-responsive moderate to severe pain.

MEROPENEM JUNO

Evaluation commenced: 31 May 2019

Registration decision: 20 Mar 2020

Date registered: 15 Jul 2020

Approval time: 162 working days (255)

meropenem trihydrate

Juno Pharmaceuticals Pty Ltd

New generic medicine

MEROPENEM JUNO (powder for injection) is indicated for treatment of the following infections, in adults and children (aged 3 months and over), when the causative organisms are known or suspected to be resistant to commonly used antibiotics:

  • Community acquired lower respiratory tract infection
  • Hospital acquired lower respiratory tract infection
  • Complicated urinary tract infectionFebrile neutropaenia
  • Intra-abdominal and gynaecological (poly microbial) infections
  • Complicated skin and skin structure infections
  • Meningitis
  • Septicaemia

June 2020

MVASI

Evaluation commenced: 1 Feb 2018

Registration decision: 16 Jan 2019

Date registered: 30 Jun 2020

Approval time: 187 working days (255)

bevacizumab

Amgen Australia Pty Ltd

New generic medicine

New Biosimilar Medicine
Metastatic Colorectal Cancer

MVASI (concentrated solution for injection) in combination with fluoropyrimidine-based chemotherapy is indicated for the treatment of patients with metastatic colorectal cancer.

Locally recurrent or metastatic Breast Cancer

MVASI in combination with paclitaxel is indicated for the first-line treatment of metastatic breast cancer in patients in whom an anthracycline-based therapy is contraindicated. (see Clinical Trials).

Advanced, metastatic or recurrent non-squamous Non-Small Cell Lung Cancer (NSCLC)

MVASI, in combination with carboplatin and paclitaxel, is indicated for first line treatment of patients with unresectable advanced, metastatic or recurrent, non-squamous, non-small cell lung cancer.

Advanced and/or metastatic Renal Cell Cancer

MVASI in combination with interferon alfa-2a is indicated for treatment of patients with advanced and/or metastatic renal cell cancer.

Grade IV Glioma

MVASI as a single agent, is indicated for the treatment of patients with Grade IV glioma after relapse or disease progression after standard therapy, including chemotherapy.

Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

MVASI in combination with carboplatin and paclitaxel, is indicated for first line treatment of patients with advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

MVASI, in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine, is indicated for the treatment of patients with first recurrence of platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have not received prior bevacizumab or other VEGF-targeted angiogenesis inhibitors.

MVASI in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens, and have not received any prior anti-angiogenic therapy including bevacizumab.

Cervical Cancer

MVASI in combination with paclitaxel and cisplatin is indicated for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. MVASI in combination with paclitaxel and topotecan is an acceptable alternative where cisplatin is not tolerated or not indicated.

AGOMELATINE ANS, AGOMELATINE SANDOZ, AGOMELATINE SCP, APO-AGOMELATINE, BLOOMS THE CHEMIST AGOMELATINE first generic

Evaluation commenced: 1 Jul 2019

Registration decision: 2 Apr 2020

Date registered: 26 Jun 2020

Approval time: 153 working days (255)

agomelatine

Southern Cross Pharma Pty Ltd

New generic medicine

AGOMELATINE ANS, AGOMELATINE SANDOZ, AGOMELATINE SCP, APO-AGOMELATINE, BLOOMS THE CHEMIST AGOMELATINE (film-coated tablet) is indicated for the treatment of major depression in adults including prevention of relapse.

APO-PRASUGREL, PRASUGREL AJS, PRASUGREL SCP, PRASUGREL TLB first generic

Evaluation commenced: 28 Feb 2019

Registration decision: 10 Feb 2020

Date registered: 26 Jun 2020

Approval time: 163 working days (255)

prasugrel

Southern Cross Pharma Pty Ltd

New generic medicine

APO-PRASUGREL, PRASUGREL AJS, PRASUGREL SCP, PRASUGREL TLB (film-coated tablet), co-administered with aspirin, are indicated for the prevention of atherothrombotic events (myocardial infarction, stroke and cardiovascular death) in patients with acute coronary syndromes (moderate to high risk unstable angina (UA), non ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI)) who are to undergo percutaneous coronary intervention (PCI).

ALEMBIC LURASIDONE, APO-LURASIDONE, BILURA, LATULEM, LURALEM, LURALEMBIC, LURASIDONE AGH, LURASIDONE AGHL, LURASIDONE APL, LURASIDONE APPL, LURASIDONE SANDOZ, LUROBI

Evaluation commenced: 2 Sep 2019

Registration decision: 10 Jun 2020

Date registered: 24 Jun 2020

Approval time: 156 working days (255)

lurasidone hydrochloride

Alembic Pharmaceuticals Australia Pty Ltd

New generic medicine

ALEMBIC LURASIDONE, APO-LURASIDONE, BILURA, LATULEM, LURALEM, LURALEMBIC, LURASIDONE AGH, LURASIDONE AGHL, LURASIDONE APL, LURASIDONE APPL, LURASIDONE SANDOZ, LUROBI (film-coated tablet) are indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

BUPRENORPHINE SANDOZ

Evaluation commenced: 31 Jul 2019

Registration decision: 5 Jun 2020

Date registered: 23 Jun 2020

Approval time: 171 working days (255)

buprenorphine

Sandoz Pty Ltd

New generic medicine

BUPRENORPHINE SANDOZ (dermal patch) is indicated for management of moderate to severe pain.

CLOBIUM, PHARMACOR CLOBAZAM first generic

Evaluation commenced: 31 May 2019

Registration decision: 3 Mar 2020

Date registered: 22 Jun 2020

Approval time: 143 working days (255)

clobazam

Pharmacor Pty Ltd

New generic medicine

CLOBIUM, PHARMACOR CLOBAZAM (uncoated tablet) is indicated for:

Adults

Short term use (up to one month) for the symptomatic management of acute anxiety and sleep disturbances associated with anxiety.

Children (4 years of age and over)

As adjunctive therapy in patients with partial refractory and Lennox-Gastaut epilepsy types who are not adequately stabilized with their current anticonvulsant therapy.

IDACIO

Evaluation commenced: 2 Sep 2019

Registration decision: 15 Jun 2020

Date registered: 17 Jun 2020

Approval time: 183 working days (255)

adalimumab

Fresenius Kabi Australia Pty Ltd

New generic medicine

New Biosimilar Medicine
Rheumatoid Arthritis

IDACIO (solution for injection) 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. This includes the treatment of patients with recently diagnosed moderate to severely active disease who have not received methotrexate.

IDACIO can be used alone or in combination with methotrexate.

Juvenile Idiopathic Arthritis
Polyarticular Juvenile Idiopathic Arthritis

IDACIO in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to one or more disease modifying anti-rheumatic drugs (DMARDs). IDACIO can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enthesitis-Related Arthritis

IDACIO is indicated for the treatment of enthesitis-related arthritis in children, who have had an inadequate response to, or who are intolerant to, conventional therapy.

Psoriatic Arthritis

IDACIO is indicated for the treatment of signs and symptoms, as well as inhibiting the progression of structural damage, of moderate to severely active psoriatic arthritis in adult patients where response to previous DMARDs has been inadequate.

Ankylosing Spondylitis

IDACIO is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Crohn's Disease in Adults and Children (≥ 6 years)

IDACIO is indicated for the treatment of moderate to severe Crohn's disease, to reduce the signs and symptoms of the disease and to induce and maintain clinical remission in patients;

  • who have had an inadequate response to conventional therapies or,
  • who have lost response to or are intolerant to infliximab
Ulcerative colitis

IDACIO is indicated for the treatment of moderate to severe ulcerative colitis in adult patients who have had an inadequate response to conventional therapy or who are intolerant to or have medical contraindications for such therapies. Patients should show a clinical response within 8 weeks of treatment to continue treatment beyond that time. (see 5.1 PHARMACODYNAMIC PROPERTIES-CLINICAL TRIALS).

Psoriasis in Adults and Children

IDACIO is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.

IDACIO is indicated for the treatment of severe chronic plaque psoriasis in children and adolescent patients from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapy.

Hidradenitis Suppurativa in Adults and Adolescents (from 12 years of age)

IDACIO is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in patients with an inadequate response to conventional systemic hidradenitis suppurativa therapy.

Uveitis

IDACIO is indicated for the treatment of non-infectious intermediate, posterior and pan-uveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid sparing, or in whom corticosteroid treatment is inappropriate.

DEXEMCIP, DEXMED, DEXMEDETOMIDINE CIPLA

Evaluation commenced: 2 Sep 2019

Registration decision: 9 Jun 2020

Date registered: 16 Jun 2020

Approval time: 157 working days (255)

dexmedetomidine hydrochloride

Cipla Australia Pty Ltd

New generic medicine

DEXEMCIP, DEXMED, DEXMEDETOMIDINE CIPLA (solution for injection) is indicated for:

Intensive care unit (ICU) sedation

Sedation of initially intubated patients during treatment in an intensive care setting. The use of DEXEMCIP by continuous infusion in these patients should not exceed 24 hours.

Procedural sedation

Sedation of non-intubated patients prior to and/or during surgical and other procedures.

ARSENIC TRIOXIDE JUNO, ARSENIC TRIOXIDE LU first generic

Evaluation commenced: 30 Aug 2019

Registration decision: 2 Jun 2020

Date registered: 11 Jun 2020

Approval time: 144 working days (255)

arsenic trioxide

Luminarie Pty Ltd

New generic medicine

ARSENIC TRIOXIDE JUNO, ARSENIC TRIOXIDE LU (concentrated solution for injection) is indicated for:

  • The induction of remission and consolidation in patients with acute promyelocytic leukaemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.
  • For the induction of remission and consolidation in patients with previously untreated acute promyelocytic leukaemia (APL), in combination with all-trans retinoic acid (ATRA) and/or chemotherapy and whose APL is characterised by the presence of the t(15:17) translocation or PML/RAR-alpha gene expression.

HYDROXYCARBAMIDE MEDICIANZ, HYDROXYCARBAMIDE MEDSURGE first generic

Evaluation commenced: 28 Feb 2019

Registration decision: 29 May 2020

Date registered: 3 Jun 2020

Approval time: 152 working days (255)

hydroxycarbamide (hydroxyurea)

Medicianz Healthcare Pty Ltd

New generic medicine

Significant tumour response to HYDROXYCARBAMIDE MEDICIANZ, HYDROXYCARBAMIDE MEDSURGE (hard capsule) has been demonstrated in chronic myelocytic leukaemia (pretreatment phase and palliative care) and recurrent, metastatic, or inoperable carcinoma of the ovary.

May 2020

MOMASONE ALCOHOL FREE

Evaluation commenced: 1 Jul 2019

Registration decision: 26 May 2020

Date registered: 29 May 2020

Approval time: 178 working days (255)

mometasone furoate

Aspen Pharma Pty Ltd

New generic medicine

MOMASONE ALCOHOL FREE (cream) is indicated for short term up to four (4) continuous weeks relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, such as psoriasis and atopic dermatitis.

Flec-EM

Evaluation commenced: 31 Dec 2018

Registration decision: 22 Apr 2020

Date registered: 27 May 2020

Approval time: 159 working days (255)

flecainide acetate

Emcure Pharmaceuticals Pty Ltd

New generic medicine

Flec-EM (uncoated tablets) is indicated for:

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

Although Flec-EM 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, Flec-EM should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.

Use of Flec-EM in chronic atrial fibrillation has not been adequately studied and is not recommended.

Life threatening ventricular arrhythmias not controlled by other drugs.

Flec-EM tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.

Teri-EM

Evaluation commenced: 28 Feb 2019

Registration decision: 6 May 2020

Date registered: 27 May 2020

Approval time: 100 working days (255)

teriflunomide

Emcure Pharmaceuticals Pty Ltd

New generic medicine

Teri-EM (film coated tablets) is indicated for the treatment of patients with relapsing forms of Multiple Sclerosis to reduce the frequency of clinical relapses and to delay the progression of physical disability.

FULVESTRANT SANDOZ first generic

Evaluation commenced: 11 Oct 2019

Registration decision: 5 May 2020

Date registered: 26 May 2020

Approval time: 104 working days (255)

fulvestrant

Sandoz Pty Ltd

New generic medicine

FULVESTRANT SANDOZ (solution for injection) is indicated for the treatment of postmenopausal women with hormone-receptor positive, locally advanced or metastatic breast cancer who have progressive disease following prior tamoxifen therapy.

SITAGLIPTIN GENERICHEALTH, SITAGLIPTIN GH, SITAGLIPTIN LAPL

Evaluation commenced: 5 Jan 2018

Registration decision: 12 Nov 2018

Date registered: 21 May 2020

Approval time: 170 working days (255)

sitagliptin hydrochloride monohydrate

Lupin Australia Pty Limited

New generic medicine

SITAGLIPTIN GENERICHEALTH, SITAGLIPTIN GH, SITAGLIPTIN LAPL (film coated tablets) are indicated for the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:

  • as monotherapy, as an adjunct to diet and exercise to improve glycaemic control in patients with type 2 diabetes mellitus, when metformin cannot be used.
  • as dual combination therapy, with metformin, or with a sulfonylurea, or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.
  • as triple combination therapy with metformin and a sulfonylurea when combination therapy with both agents does not provide adequate glycaemic control.
  • as add-on combination therapy with insulin (with or without metformin).

CIPLA MEDROXYPROGESTERONE, DEPROCIP, MEDPROCIP

Evaluation commenced: 31 Jul 2019

Registration decision: 29 Apr 2020

Date registered: 13 May 2020

Approval time: 145 working days (255)

medroxyprogesterone acetate

Cipla Australia Pty Ltd

New generic medicine

CIPLA MEDROXYPROGESTERONE, DEPROCIP, MEDPROCIP (suspension for injection) are indicated for:

Carcinoma

Palliative treatment of recurrent and/or metastatic breast or renal cell cancer and of inoperable recurrent or metastatic endometrial carcinoma.

Endometriosis

For use in the treatment of visually proven (laparoscopy) endometriosis where the required end-point of treatment is pregnancy, or for the control of symptoms when surgery is contraindicated or has been unsuccessful.

Contraception (ovulation suppression)

For long-term prevention of pregnancy in women when administered at 3-month intervals.

Since loss of bone mineral density (BMD) may occur in pre-menopausal women, who use medroxyprogesterone acetate long-term (greater than 2 years), women should be assessed before starting treatment for contraception or endometriosis, for the risk of osteoporosis. Women under the age of 18 years may be at risk of failing to achieve their predicted peak BMD.

ADIR TADALAFIL, ADIRA TADALAFIL, ADIRAMED TADALAFIL, ADIRAMEDICA TADALAFIL, NOUMED TADALAFIL, TADALAFIL LUPIN

Evaluation commenced: 31 Jan 2019

Registration decision: 16 Apr 2020

Date registered: 12 May 2020

Approval time: 254 working days (255)

tadalafil

AdiraMedica Pty Ltd

New generic medicine

ADIR TADALAFIL, ADIRA TADALAFIL, ADIRAMED TADALAFIL, ADIRAMEDICA TADALAFIL, NOUMED TADALAFIL, TADALAFIL LUPIN (film coated tablets) are indicated for the treatment of erectile dysfunction (ED) in adult males.

LURASIDONE GH, LURASIDONE LAPL, LURASIDONE LUPIN

Evaluation commenced: 31 May 2019

Registration decision: 28 Feb 2020

Date registered: 7 May 2020

Approval time: 135 working days (255)

lurasidone hydrochloride

Lupin Australia Pty Limited

New generic medicine

LURASIDONE GH, LURASIDONE LAPL, LURASIDONE LUPIN (film coated tablets) are indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

CIPLA GEFITINIB, GEFTICIP, GEFTIRESS

Evaluation commenced: 1 Jul 2019

Registration decision: 23 Apr 2020

Date registered: 6 May 2020

Approval time: 164 working days (255)

gefitinib

Cipla Australia Pty Ltd

New generic medicine

CIPLA GEFITINIB, GEFTICIP, GEFTIRESS (film coated tablets) are indicated for the treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) whose tumours express activating mutations of the EGFR tyrosine kinase.

ACEOMEZ, ESOMEPRAZOLE JGL, ESOMEPRAZOLE SPS, JUBESO, JUBIUM

Evaluation commenced: 30 Jun 2017

Registration decision: 28 Mar 2018

Date registered: 4 May 2020

Approval time: 126 working days (255)

esomeprazole magnesium

Jubilant Pharma Australia Pty Ltd

New generic medicine

ACEOMEZ, ESOMEPRAZOLE JGL, ESOMEPRAZOLE SPS, JUBESO, JUBIUM (enteric coated tablet) are indicated for:

Gastro-Oesophageal Reflux Disease (GORD).
  • treatment of erosive reflux oesophagitis
  • long-term management of patients with healed oesophagitis to prevent relapse
  • symptomatic treatment of gastro-oesophageal reflux disease (GORD)
Patients requiring NSAID therapy.
  • short-term treatment of upper gastrointestinal symptoms associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy.
  • healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy
  • prevention of gastric and duodenal ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk.
  • prevention of rebleeding of gastric or duodenal ulcers following treatment with esomeprazole IV (available in other brands) solution by intravenous infusion.
Pathological hypersecretory conditions including Zollinger-Ellison syndrome and idiopathic hypersecretion.

In combination with appropriate antibiotics for:

  • healing of duodenal ulcer associated with Helicobacter pylori
  • eradication of Helicobacter pylori in patients with active or healed peptic ulcer

CIPLA ICATIBANT, ICATICIP, ICAZYR first generic

Evaluation commenced: 4 Mar 2019

Registration decision: 29 Apr 2020

Date registered: 4 May 2020

Approval time: 164 working days (255)

icatibant acetate

Cipla Australia Pty Ltd

New generic medicine

CIPLA ICATIBANT, ICATICIP, ICAZYR (solution for injection) are indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase-inhibitor deficiency.

PHENTERMINE GENERICHEALTH, PHENTERMINE GH, PHENTERMINE LAPL

Evaluation commenced: 2 Jul 2018

Registration decision: 25 Sep 2019

Date registered: 4 May 2020

Approval time: 191 working days (255)

phentermine

Lupin Australia Pty Limited

New generic medicine

PHENTERMINE GENERICHEALTH, PHENTERMINE GH, PHENTERMINE LAPL (modified release capsule) is an anorectic agent indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or greater. The treatment with PHENTERMINE GENERICHEALTH, PHENTERMINE GH, PHENTERMINE can be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m2), which increases the risk of morbidity from a number of disorders. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.

April 2020

AKM GLICLAZIDE, PHARMACOR GLICLAMIRON, PHARMACOR GLICLARON, PHARMACOR GLICLAZIDE, PHARMACOR GLICLAZIDE MR

Evaluation commenced: 31 May 2019

Registration decision: 27 Mar 2020

Date registered: 29 Apr 2020

Approval time: 146 working days (255)

gliclazide

Pharmacor Pty Ltd

New generic medicine

AKM GLICLAZIDE, PHARMACOR GLICLAMIRON, PHARMACOR GLICLARON, PHARMACOR GLICLAZIDE, PHARMACOR GLICLAZIDE MR (modified release tablet) are indicated for the treatment of type II diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.

During controlled clinical trials in patients with type II diabetes, a modified release formulation of gliclazide (30 mg - 120 mg), taken as a single daily dose, was shown to be effective long term in controlling blood glucose levels, based on monitoring of HbA1c.

DARUNAVIR JUNO

Evaluation commenced: 1 Jul 2019

Registration decision: 15 Apr 2020

Date registered: 22 Apr 2020

Approval time: 154 working days (255)

darunavir

Accelagen Pty Ltd

New generic medicine

Adult patients

DARUNAVIR JUNO (film coated tablets) (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adult patients.

Paediatric patients

DARUNAVIR JUNO (with low dose ritonavir as a pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in treatment-experienced paediatric patients aged 6 years and older, weighing at least 20 kg.

BPA-FLECAINIDE

Evaluation commenced: 31 May 2019

Registration decision: 20 Mar 2020

Date registered: 15 Apr 2020

Approval time: 164 working days (255)

flecainide acetate

Beximco Pharmaceuticals Australia Pty Ltd

New generic medicine

BPA-FLECAINIDE (tablets) is indicated for:

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

Although BPA-FLECAINIDE 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, BPA-FLECAINIDE should be used with extreme caution, preferably after other antiarrhythmic drugs have been tried or considered inappropriate.

Use of BPA-FLECAINIDE in chronic atrial fibrillation has not been adequately studied and is not recommended.

Life threatening ventricular arrhythmias not controlled by other drugs.

BPA-FLECAINIDE tablets are used for continuous maintenance of normal rhythm following initial oral or intravenous (available in other brands) therapy or conversion by other means.

Prescribers should also consult the 'Special Warnings and Precautions for Use' section of this Product Information.

CIPLA PREGABALIN, CIPGABLIN, PREGACIPLIN

Evaluation commenced: 31 May 2019

Registration decision: 6 Apr 2020

Date registered: 15 Apr 2020

Approval time: 157 working days (255)

pregabalin

Cipla Australia Pty Ltd

New generic medicine

CIPLA PREGABALIN, CIPGABLIN, PREGACIPLIN (capsules) are indicated for the treatment of neuropathic pain in adults.

CIPLA PREGABALIN, CIPGABLIN, PREGACIPLIN are indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

AMBRISENTAN MYLAN, AMBRISENTAN MYL

Evaluation commenced: 11 May 2018

Registration decision: 14 Mar 2019

Date registered: 1 Apr 2020

Approval time: 164 working days (255)

ambrisentan

Alphapharm Pty Ltd

New generic medicine

AMBRISENTAN MYLAN, AMBRISENTAN MYL (film-coated tablets) are indicated for treatment of:

  • idiopathic pulmonary arterial hypertension (PAH),
  • pulmonary arterial hypertension associated with connective tissue disease (PAHCTD), in patients with WHO functional class II, III or IV symptoms.

Ambrisentan in combination with Tadalafil is indicated for the treatment of WHO Group I pulmonary arterial hypertension in patients with WHO functional class II, III or IV symptoms.

March 2020

DAPTOMYCIN ACCORD, DAPTOMYCIN INTAS

Evaluation commenced: 31 May 2019

Registration decision: 13 Mar 2020

Date registered: 24 Mar 2020

Approval time: 165 working days (255)

daptomycin

Accord Healthcare Pty Ltd

New generic medicine

DAPTOMYCIN ACCORD, DAPTOMYCIN INTAS (powder for injection) is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, daptomycin should be co- administered with appropriate antibacterial agent(s).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Daptomycin is not indicated for the treatment of pneumonia.

Adult patients (18 years of age and over)
Complicated Skin and Skin Structure Infections

Daptomycin is indicated for the treatment of adults (18 years of age and over) with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

Daptomycin is indicated in adults (18 years of age and over) for Staphylococcus aureus bloodstream infections (bacteraemia), including right-sided native valve infective endocarditis (RIE), caused by methicillin-susceptible and methicillin-resistant isolates. The efficacy of daptomycin in patients with prosthetic heart valves or in left-sided endocarditis due to Staphylococcus aureus has not been demonstrated. In the setting of Staphylococcus aureus bacteraemia (SAB), if a focus of infection is diagnosed as left-sided endocarditis after daptomycin therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy.

Paediatric patients (1 to 17 years of age)

Daptomycin is not indicated for treatment of patients less than 1 year of age.

Daptomycin has not been studied in treatment of infective endocarditis in children.

Complicated Skin and Skin Structure Infections

Daptomycin is indicated for the treatment of patients aged 1 to 17 years with complicated skin and skin structure infections (cSSSI) who require parenteral therapy and who have intolerance to alternative agents (especially penicillin allergy) or who have intolerance to alternative agents (especially penicillin allergy) or who have failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

Daptomycin is indicated in paediatric patients (1 to 17 years of age) with Staphylococcus aureus bacteraemia not due to pneumonia, caused by daptomycin-susceptible isolates. Empiric treatment should be reviewed based on the results of susceptibility testing. Prescribing should be in accordance with nationally or locally-endorsed guidelines for the treatment of Staphylococcus aureus bacteraemia.

SOLIFENACIN MYLAN

Evaluation commenced: 29 Feb 2016

Registration decision: 12 Dec 2016

Date registered: 19 Mar 2020

Approval time: 151 working days (255)

solifenacin succinate

Alphapharm Pty Ltd

New generic medicine

SOLIFENACIN MYLAN (tablet) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

MSN-LURASIDONE first generic

Evaluation commenced: 1 Jul 2019

Registration decision: 13 Mar 2020

Date registered: 17 Mar 2020

Approval time: 131 working days (255)

lurasidone hydrochloride

Accelagen Pty Ltd

New generic medicine

MSN-LURASIDONE (film-coated tablet) is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).

DESFLURANE SANDOZ

Evaluation commenced: 31 Mar 2017

Registration decision: 13 Dec 2017

Date registered: 12 Mar 2020

Approval time: 134 working days (255)

desflurane

Sandoz Pty Ltd

New generic medicine

DESFLURANE SANDOZ (solution for inhalation) is indicated as an inhalation agent for maintenance of anaesthesia. DESFLURANE SANDOZ is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events.

SEVOFLURANE SANDOZ

Evaluation commenced: 31 Mar 2017

Registration decision: 27 Feb 2018

Date registered: 12 Mar 2020

Approval time: 145 working days (255)

sevoflurane

Sandoz Pty Ltd

New generic medicine

SEVOFLURANE SANDOZ (solution for inhalation) may be used for induction and maintenance of general anaesthesia in adult and paediatric patients undergoing surgery.

IRINOTECAN ACCORD, IRINOTECAN INTAS

Evaluation commenced: 31 May 2019

Registration decision: 2 Mar 2020

Date registered: 5 Mar 2020

Approval time: 178 working days (255)

irinotecan hydrochloride trihydrate

Accord Healthcare Pty Ltd

New generic medicine

IRINOTECAN ACCORD, IRINOTECAN INTAS (concentrated solution for injection) is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

NALOXONE RMB, NALOXONE SXP, NALOXONE TLB

Evaluation commenced: 2 Apr 2019

Registration decision: 28 Feb 2020

Date registered: 5 Mar 2020

Approval time: 114 working days (255)

naloxone hydrochloride dihydrate

Southern Cross Pharma Pty Ltd

New generic medicine

NALOXONE RMB, NALOXONE SXP, NALOXONE TLB (solution for injection) is indicated for the complete or partial reversal of opioid depression, including respiratory depression, induced by natural and synthetic opioids including propoxyphene, methadone, codeine, morphine and heroin, and the mixed opioid agonist-antagonist analgesics such as pentazocine. Naloxone is also indicated for the diagnosis of suspected acute opioid overdosage.

POSACONAZOLE SANDOZ first generic

Evaluation commenced: 8 Jul 2019

Registration decision: 24 Feb 2020

Date registered: 3 Mar 2020

Approval time: 117 working days (255)

posaconazole

Sandoz Pty Ltd

New generic medicine

POSACONAZOLE SANDOZ (modified release tablet) is indicated for use in the treatment of the following invasive fungal infections in patients 13 years of age or older:

  • Invasive aspergillosis in patients intolerant of, or with disease that is refractory to, alternative therapy.
  • Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of, or with disease that is refractory to, alternative therapy.

POSACONAZOLE SANDOZ is also indicated for the prophylaxis of invasive fungal infections among patients 13 years of age and older, who are at high risk of developing these infections, such as patients with prolonged neutropenia or haematopoietic stem cell transplant (HSCT) recipients.

February 2020

APO-TAMSULOSIN SR, BLOOMS THE CHEMIST TAMSULOSIN SR, TAMSULOSIN ANS SR, TAMSULOSIN SCP SR

Evaluation commenced: 31 Jan 2019

Registration decision: 19 Nov 2019

Date registered: 25 Feb 2020

Approval time: 159 working days (255)

tamsulosin hydrochloride

Southern Cross Pharma Pty Ltd

New generic medicine

APO-TAMSULOSIN SR, BLOOMS THE CHEMIST TAMSULOSIN SR, TAMSULOSIN ANS SR, TAMSULOSIN SCP SR (modified release tablet) are indicated for the relief of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

PEMETREXED-AFT

Evaluation commenced: 30 Nov 2018

Registration decision: 10 Feb 2020

Date registered: 25 Feb 2020

Approval time: 254 working days (255)

pemetrexed disodium hemipentahydrate

AFT Pharmaceuticals Pty Ltd

New generic medicine

Malignant Pleural Mesothelioma

PEMETREXED-AFT (powder for injection), in combination with cisplatin, is indicated for the treatment of patients with malignant pleural mesothelioma.

Non-Small Cell Lung Cancer

PEMETREXED-AFT in combination with cisplatin is indicated for initial treatment of patients with locally advanced or metastatic non-small cell lung cancer other than predominantly squamous cell histology.

PEMETREXED-AFT as monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer other than predominantly squamous cell histology after prior platinum-based chemotherapy.

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE B&B, SODIUM NITROPRUSSIDE MEDSURGE, SODIUM NITROPRUSSIDE MICRO MEDICS first generic

Evaluation commenced: 8 May 2019

Registration decision: 13 Feb 2020

Date registered: 25 Feb 2020

Approval time: 149 working days (255)

sodium nitroprusside

Micro Labs Pty Ltd

New generic medicine

SODIUM NITROPRUSSIDE, SODIUM NITROPRUSSIDE B&B, SODIUM NITROPRUSSIDE MEDSURGE, SODIUM NITROPRUSSIDE MICRO MEDICS (concentrated solution for injection) are indicated for:

  • Immediate reduction of blood pressure in patients with hypertensive crises. Concomitant oral antihypertensive medication should be started while the hypertensive emergency is being brought under control with sodium nitroprusside.
  • Producing controlled hypotension during anaesthesia in order to reduce bleeding in surgical procedures where surgeon and anaesthetist deem it appropriate.
  • Short term therapy of cardiac failure, to enhance cardiac output and lower myocardial oxygen requirements. patients should be commenced on oral therapy as soon as possible.

TALMINEX first generic

Evaluation commenced: 31 Jan 2019

Registration decision: 13 Feb 2020

Date registered: 25 Feb 2020

Approval time: 163 working days (255)

oseltamivir phosphate

Accelagen Pty Ltd

New generic medicine

TALMINEX (capsules) is indicated for the treatment of infections due to influenza A and B viruses in adults and children including full-term neonates. Treatment should commence as soon as possible, but no later than 48 hours after the onset of the initial symptoms of infection.

TALMINEX is indicated for the prevention of influenza in adults and children aged 1 year and older. Vaccination is the preferred method of routine prophylaxis against infection with influenza virus.

APO-PACLITAXEL, PACLITAXEL APOTEX

Evaluation commenced: 30 Apr 2018

Registration decision: 6 Feb 2020

Date registered: 14 Feb 2020

Approval time: 253 working days (255)

paclitaxel

Apotex Pty Ltd

New generic medicine

Metastatic Breast Cancer

Albumin-bound APO-PACLITAXEL, PACLITAXEL APOTEX (powder for injection) are indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.

METARAMINOL MYX

Evaluation commenced: 30 Nov 2018

Registration decision: 13 Feb 2020

Date registered: 14 Feb 2020

Approval time: 162 working days (255)

metaraminol tartrate

Mayne Pharma International Pty Ltd

New generic medicine

METARAMINOL MYX (solution for injection) 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.

It may also be useful as an adjunct in the treatment of hypotension due to cardiogenic shock or septicaemia.

January 2020

PIRAMAL DESFLURANE first generic

Evaluation commenced: 2 Apr 2019

Registration decision: 23 Dec 2019

Date registered: 21 Jan 2020

Approval time: 140 working days (255)

desflurane

Piramal Critical Care Pty Ltd

New generic medicine

PIRAMAL DESFLURANE (inhalation bottle) is indicated as an inhalation agent for maintenance of anaesthesia. Desflurane is not recommended for mask induction of anaesthesia because of a high incidence of moderate to severe upper airway adverse events.

BORTEZOMIB-AFT

Evaluation commenced: 31 Oct 2018

Registration decision: 14 Jan 2020

Date registered: 21 Jan 2020

Approval time: 253 working days (255)

bortezomib

AFT Pharmaceuticals Pty Ltd

New generic medicine

BORTEZOMIB-AFT (powder for injection), 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.

BORTEZOMIB-AFT, 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.

BORTEZOMIB-AFT is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

BORTEZOMIB-AFT in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

VIZO-PF BIMATOPROST

Evaluation commenced: 1 Apr 2019

Registration decision: 13 Jan 2020

Date registered: 17 Jan 2020

Approval time: 119 working days (255)

bimatoprost

AFT Pharmaceuticals Pty Ltd

New generic medicine

VIZO-PF BIMATOPROST (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.

MSN-SOLIFENACIN

Evaluation commenced: 28 Feb 2019

Registration decision: 24 Sep 2019

Date registered: 10 Jan 2020

Approval time: 96 working days (255)

solifenacin succinate

Accelagen Pty Ltd

New generic medicine

MSN-SOLIFENACIN (film-coated tablet) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

JUNOMINE ER, PHENTERMINE JUNO ER first generic

Evaluation commenced: 30 Nov 2018

Registration decision: 2 Oct 2019

Date registered: 9 Jan 2020

Approval time: 134 working days (255)

phentermine hydrochloride

Juno PC Holdings Pty Limited

New generic medicine

JUNOMINE ER, PHENTERMINE JUNO ER (extended release tablet) is an anorectic agent indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or greater.

The treatment with Phentermine can be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m2), which increases the risk of morbidity from a number of disorders. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.