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Prescription medicines: registration of new generic medicines and biosimilar medicines
18 January 2021
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.
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
December 2020
FULVESTRANT ACCORD, FULVESTRANT INTAS
Evaluation commenced: 2 Mar 2020
Registration decision: 11 Dec 2020
Date registered: 22 Dec 2020
Approval time: 153 working days (225)
fulvestrant
Accord Healthcare Pty Ltd
New generic medicine
FULVESTRANT ACCORD, FULVESTRANT INTAS (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.
ATORVASTATIN SANDOZ
Evaluation commenced: 4 Dec 2019
Registration decision: 14 Sep 2020
Date registered: 10 Dec 2020
Approval time: 132 working days (225)
atorvastatin calcium trihydrate
Sandoz Pty Ltd
New generic medicine
ATORVASTATIN SANDOZ (film coated tablet) 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, dysproteinaemia, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.
ATORVASTATIN SANDOZ 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 to reduce the risk of non-fatal myocardial infarction (MI) and non-fatal stroke.
These effects do not replace the need to independently control known causes of cardiovascular (CV) mortality and morbidity such as hypertension, diabetes and smoking .
CIPLA TENOFOVIR + EMTRICITABINE 300/200, TENOEMTRICIP 300/200, TENVIR EMTRI 300/200
Evaluation commenced: 2 Jan 2020
Registration decision: 13 Nov 2020
Date registered: 9 Dec 2020
Approval time: 145 working days (225)
emtricitabine; tenofovir disoproxil fumarate
Cipla Australia Pty Ltd
New generic medicine
Treatment of HIV-1 infection
CIPLA TENOFOVIR + EMTRICITABINE 300/200 (film coated tablet) is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.
Pre-exposure prophylaxis
CIPLA TENOFOVIR + EMTRICITABINE 300/200 is indicated in combinatin with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples.
BENDAMUSTINE MYLAN 
Evaluation commenced: 30 Aug 2019
Registration decision: 12 Jun 2020
Date registered: 7 Dec 2020
Approval time: 149 working days (225)
bendamustine hydrochloride
Alphapharm Pty Ltd
New generic medicine
BENDAMUSTINE MYLAN 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 patients ineligible for autologous stem cell transplantation.
- Relapsed/Refractory indolent Non-Hodgkin's lymphoma.
OSELTAMIVIR GH, OSELTAMIVIR LUPIN, OSELTAMIVIR GENERICHEALTH
Evaluation commenced: 31 Jan 2020
Registration decision: 26 Oct 2020
Date registered: 3 Dec 2020
Approval time: 140 working days (225)
oseltamivir phosphate
Lupin Australia Pty Limited
New generic medicine
OSELTAMIVIR GH, OSELTAMIVIR LUPIN, OSELTAMIVIR GENERICHEALTH (hard capsule) 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.
OSELTAMIVIR GH, OSELTAMIVIR LUPIN, OSELTAMIVIR GENERICHEALTH 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.
November 2020
SUNITINIB SANDOZ
Evaluation commenced: 3 Jul 2019
Registration decision: 24 Apr 2020
Date registered: 26 Nov 2020
Approval time: 164 working days (175)
sunitinib
Sandoz Pty Ltd
New generic medicine
SUNITINIB SANDOZ (capsule) is indicated for:
- treatment of advanced renal cell carcinoma (RCC),
- treatment of gastrointestinal stromal tumour (GIST) after failure of imatinib mesilate treatment due to resistance or intolerance,
- treatment of unresectable, well-differentiated pancreatic neuroendocrine tumours (pancreatic NET).
OCTREOTIDE DEPOT
Evaluation commenced: 31 Oct 2019
Registration decision: 9 Nov 2020
Date registered: 25 Nov 2020
Approval time: 122 working days (175)
octreotide
Teva Pharma Australia Pty Ltd
New generic medicine
OCTREOTIDE DEPOT (solution for injection ) is indicated:
Acromegaly
For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment but who are adequately controlled on s.c. treatment with octreotide. Octreotide Depot is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.
Gastro-entero-pancreatic tumours
For the relief of symptoms associated with the following functional tumours of the gastro-enteropancreatic endocrine system:
- Carcinoid tumours with features of the carcinoid syndrome
- Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately controlled on subcutaneous treatment with octreotide
Octreotide Depot is not curative in these patient.
Advanced Neuroendocrine Tumours of the Midgut
Treatment of patients with progression of well-differentiated, advanced neuroendocrine tumours of the midgut or suspected midgut origin.
ALEMBIC DEFERASIROX, CHEALAC, CHEALEMBIC, DEFERASIROX AGH, DEFERASIROX AGHL, DEFERASIROX APL, DEFERASIROX APPL, JADELEM
Evaluation commenced: 2 Jan 2020
Registration decision: 26 Oct 2020
Date registered: 16 Nov 2020
Approval time: 164 working days (255)
deferasirox
Alembic Pharmaceuticals Australia Pty Ltd
New generic medicine
ALEMBIC DEFERASIROX, CHEALAC, CHEALEMBIC, DEFERASIROX AGH, DEFERASIROX AGHL, DEFERASIROX APL, DEFERASIROX APPL, JADELEM (tablet) is indicated for 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.
PHENYLEPHRINE ACCORD, PHENYLEPHRINE INTAS
Evaluation commenced: 29 Jan 2020
Registration decision: 11 Nov 2020
Date registered: 16 Nov 2020
Approval time: 157 working days (255)
phenylephrine hydrochloride
Accord Healthcare Pty Ltd
New generic medicine
PHENYLEPHRINE ACCORD, PHENYLEPHRINE INTAS (solution for injection) is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anaesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anaesthesia, and as a vasoconstrictor in regional analgesia.
AKM POSACONAZOLE, AXOFIL, PHARMACOR POSACONAZOLE
Evaluation commenced: 31 Jan 2020
Registration decision: 30 Oct 2020
Date registered: 12 Nov 2020
Approval time: 144 working days (255)
posaconazole
Pharmacor Pty Ltd
New generic medicine
AKM POSACONAZOLE, AXOFIL, PHARMACOR POSACONAZOLE (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 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.
BPA SITAGLIPTIN TABLET
Evaluation commenced: 31 Jan 2020
Registration decision: 10 Nov 2020
Date registered: 12 Nov 2020
Approval time: 132 working days (255)
sitagliptin phosphate
Beximco Pharmaceuticals Australia Pty Ltd
New generic medicine
BPA SITAGLIPTIN TABLE is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:
- monotherapy when metformin is considered inappropriate due to intolerance; or
- in combination with other anti-hyperglycaemic agents, including insulin,(see 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials, 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS for available data on different add-on combination therapies).
LURASIDONE SUN
Evaluation commenced: 30 Mar 2020
Registration decision: 10 Nov 2020
Date registered: 12 Nov 2020
Approval time: 132 working days (255)
lurasidone hydrochloride
Sun Pharma ANZ Pty Ltd
New generic medicine
LURASIDONE SUN (tablet) is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).
NITROPRUSSIDE-EMC
Evaluation commenced: 5 Feb 2020
Registration decision: 14 Oct 2020
Date registered: 12 Nov 2020
Approval time: 130 working days (255)
sodium nitroprusside
Emcure Pharmaceuticals Pty Ltd
New generic medicine
NITROPRUSSIDE-EMC (concentrated solution for injection) is 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.
SITAGLIPTIN SANDOZ
Evaluation commenced: 31 Oct 2019
Registration decision: 17 Jul 2020
Date registered: 10 Nov 2020
Approval time: 139 working days (255)
sitagliptin hydrochloride monohydrate
Sandoz Pty Ltd
New generic medicine
SITAGLIPTIN SANDOZ (tablet) is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus as:
- monotherapy when metformin is considered inappropriate due to intolerance; or
- in combination with other anti-hyperglycaemic agents, including insulin
SOLIFENACIN SANDOZ
Evaluation commenced: 2 Jan 2019
Registration decision: 15 Oct 2019
Date registered: 4 Nov 2020
Approval time: 153 working days (255)
solifenacin succinate
Sandoz Pty Ltd
New generic medicine
SOLIFENACIN SANDOZ (tablet) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.
CINACALCET MYLAN
Evaluation commenced: 4 Jul 2017
Registration decision: 3 Apr 2018
Date registered: 3 Nov 2020
Approval time: 147 working days (255)
cinacalcet hydrochloride
Alphapharm Pty Ltd
New generic medicine
CINACALCET MYLAN (tablet) may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease, receiving dialysis (see CLINICAL TRIALS). CINACALCET MYLAN should be used as adjunctive therapy.
CINACALCET MYLAN is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.
CINACALCET MYLAN may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option.
GANIRELIX SUN
Evaluation commenced: 31 Jan 2020
Registration decision: 2 Nov 2020
Date registered: 2 Nov 2020
Approval time: 146 working days (255)
ganirelix acetate
Sun Pharma ANZ Pty Ltd
New generic medicine
GANIRELIX SUN (solution for injection) is indicated for the prevention of premature luteinisation and ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick up and assisted reproductive techniques.
October 2020
ALBRAXIP, CIPLA PACLITAXEL, NANOPACLICIP
Evaluation commenced: 2 Jan 2020
Registration decision: 12 Oct 2020
Date registered: 29 Oct 2020
Approval time: 152 working days (255)
paclitaxel
Cipla Australia Pty Ltd
New generic medicine
Metastatic breast cancer
ALBRAXIP, CIPLA PACLITAXEL, NANOPACLICIP (powder for injection) is indicated for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.
ERLOTINIB SANDOZ
Evaluation commenced: 2 Jan 2020
Registration decision: 2 Sep 2020
Date registered: 28 Oct 2020
Approval time: 121 working days (255)
erlotinib hydrochloride
Sandoz Pty Ltd
New generic medicine
Non-small cell lung cancer
ERLOTINIB SANDOZ (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 SANDOZ 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 SANDOZ 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 SANDOZ in combination with gemcitabine is indicated for the treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
NITROFURANTOIN EM
Evaluation commenced: 31 Jul 2019
Registration decision: 7 Oct 2020
Date registered: 22 Oct 2020
Approval time: 178 working days (255)
nitrofurantoin
Emcure Pharmaceuticals Pty Ltd
New generic medicine
NITROFURANTOIN EM (hard capsule) is indicated for the treatment of urinary tract infections such as cystitis and pyelitis when due to susceptible pathogens. Nitrofurantoin does not reach effective levels in plasma and consequently is not indicated for cortical or perinephric abscesses and in cases of prostatitis.
ARSENIC TRIOXIDE ACCORD
Evaluation commenced: 2 Dec 2019
Registration decision: 11 Sep 2020
Date registered: 20 Oct 2020
Approval time: 164 working days (255)
arsenic trioxide
Accord Healthcare Pty Ltd
New generic medicine
ARSENIC TRIOXIDE ACCORD (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.
LURACOR, PHARMACOR LURASIDONE
Evaluation commenced: 31 Oct 2019
Registration decision: 28 Aug 2020
Date registered: 16 Oct 2020
Approval time: 152 working days (255)
lurasidone hydrochloride
Pharmacor Pty Ltd
New generic medicine
LURACOR, PHARMACOR LURASIDONE (film coated tablet) is indicated for the treatment of schizophrenia in adults and adolescents (aged 13 to 17 years).
DIAXEMET XR, PHARMACOR METFORMIN XR
Evaluation commenced: 31 Oct 2019
Registration decision: 31 Aug 2020
Date registered: 16 Oct 2020
Approval time: 136 working days (255)
metformin hydrochloride
Pharmacor Pty Ltd
New generic medicine
DIAXEMET XR, PHARMACOR METFORMIN XR (modified release tablet) is indicated in the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise alone does not result in adequate glycaemic control. DIAXEMET XR, PHARMACOR METFORMIN XR may be used as monotherapy or in combination with other oral antidiabetic agents, or with insulin.
TRUVELOG
Evaluation commenced: 2 Dec 2019
Registration decision: 14 Oct 2020
Date registered: 15 Oct 2020
Approval time: 170 working days (255)
insulin aspart
Sanofi-Aventis Australia Pty Ltd
New biosimilar medicine
TRUVELOG (solution for injection) is indicated for the treatment of diabetes mellitus.
ETERA, RYMTI
Evaluation commenced: 31 Oct 2018
Registration decision: 29 Jan 2020
Date registered: 1 Oct 2020
Approval time: 226 working days (255)
etanercept
Lupin Australia Pty Limited
New biosimilar medicine
ETERA, RYMTI (solution for injection) is indicated for the treatment of:
Adults
Rheumatoid Arthritis
Active, adult rheumatoid arthritis (RA) in patients who have had inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). ETERA, RYMTI can be used in combination with methotrexate.
Severe, active rheumatoid arthritis in adults to slow progression of disease-associated structural damage in patients at high risk of erosive disease.
Psoriatic Arthritis
The signs and symptoms of active and progressive psoriatic arthritis in adults, when the response to previous disease-modifying antirheumatic therapy has been inadequate. Etanercept has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
Plaque Psoriasis
Adult patients with moderate to severe chronic plaque psoriasis, who are candidates for phototherapy or systemic therapy.
Ankylosing Spondylitis
The signs and symptoms of active ankylosing spondylitis in adults.
Non-Radiographic Axial Spondyloarthritis
Treatment of adults with active* non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or MRI change who have had an inadequate response to NSAIDs.
*Active disease is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥ 4.
Children and Adolescents
Children and adolescents weighing less than 62.5 kg should not receive ETERA, RYMTI. These patients should be accurately dosed on a mg/kg basis with other etanercept products.
Juvenile Idiopathic Arthritis
Active polyarthritis (rheumatoid factor positive or negative) in children and adolescents, aged 2 to 17 years, who have had an inadequate response to one or more DMARDs.
Active extended oligoarthritis in children and adolescents, aged 2 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.
Active enthesitis-related arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, conventional therapy.
Active psoriatic arthritis in adolescents, aged 12 to 17 years, who have had an inadequate response to, or who have proved intolerant to, methotrexate.
Etanercept has not been studied in children aged less than 2 years.
Paediatric Plaque Psoriasis
Chronic, severe plaque psoriasis in children and adolescents from 4 to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Duration of therapy to be no longer than 24 weeks and treatment to be ceased after 12 weeks if a significant Psoriasis Area and Severity Index (PASI) response is not achieved.
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.
BENDAMUSTINE GEN, BENDAMUSTINE JUNO, BENDAMUSTINE LU
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.
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.
XOROX 
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.
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.
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.
BELLA ETHINYLOESTRADIOL/DROPIRENONE, ETHINYLOESTRADIOL/DROPIRENONE GENERIC HEALTH, ETHINYLOESTRADIOL/DROPIRENONE GH, ETHINYLOESTRADIOL/DROPIRENONE LAPL, ETHINYLOESTRADIOL/DROPIRENONE LL, ETHINYLOESTRADIOL/DROPIRENONE LUPIN
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.
PLERIXAFOR APOTEX
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).
ERLOTINIB APOTEX
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.
CARMUSTINE DR REDDY'S, CARMUSTINE-DRLA, CARMUSTINE-JUNO, REDDY'S-CARMUSTINE
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.
APO-PRASUGREL, PRASUGREL AJS, PRASUGREL SCP, PRASUGREL TLB
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).
AGOMELATINE ANS, AGOMELATINE SANDOZ, AGOMELATINE SCP, APO-AGOMELATINE, BLOOMS THE CHEMIST AGOMELATINE
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.
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
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
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
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
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.
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.
CIPLA ICATIBANT, ICATICIP, ICAZYR
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.
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
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.
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.
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.
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
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).
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.
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.
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.
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.
POSACONAZOLE SANDOZ
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
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
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
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-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).
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.
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.
January 2020
PIRAMAL DESFLURANE
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
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.