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Prescription medicines: registration of new generic medicines and biosimilar medicines

19 August 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.


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, 2021

Previous years

2020 2019 2018 2017

July 2021

ERIBULIN SANDOZ first generic

Evaluation commenced:

Registration decision:

Date registered: 29 Jul 2021

Approval time: 149 (255 working days)

eribulin mesilate

Sandoz Pty Ltd

New generic medicine

ERIBULIN SANDOZ (solution for injection) is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless these are contraindicated.

ERIBULIN SANDOZ is indicated for the treatment of patients with unresectable liposarcoma who have received prior chemotherapy for advanced or metastatic disease.

LEVOXINE first generic

Evaluation commenced:

Registration decision:

Date registered: 29 Jul 2021

Approval time: 173 (255 working days)

levothyroxine sodium

Sun Pharma ANZ Pty Ltd

New generic medicine

LEVOXINE (tablet) is indicated for the management of demonstrated thyroid hormone deficiency.

LEVOXINE is also used to suppress thyrotropin (TSH) for the management of TSH-responsive tumours of the thyroid.

LENALEX, LENALIDE, LENALIDOMIDE JUNO

Evaluation commenced: 31 Jul 2020

Registration decision: 22 Jun 2021

Date registered: 23 Jul 2021

Approval time: 149 (255 working days)

lenalidomide

Juno Pharmaceuticals Pty Ltd

New generic medicine

Multiple Myeloma (MM)

LENALEX, LENALIDE, LENALIDOMIDE JUNO (capsule) is indicated for treatment of multiple myeloma.

Myelodysplastic Syndromes (MDS)

LENALEX, LENALIDE, LENALIDOMIDE JUNO is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Mantle Cell Lymphoma (MCL)

LENALEX, LENALIDE, LENALIDOMIDE JUNO is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

AKM DIMETHYL FUMARATE, FURATEC, PHARMACOR DIMETHYL FUMARATE

Evaluation commenced: 31 Oct 2018

Registration decision: 13 Sep 2019

Date registered: 14 Jul 2021

Approval time: 177 (255 working days)

dimethyl fumarate

Pharmacor Pty Ltd

New generic medicine

AKM DIMETHYL FUMARATE, FURATEC, PHARMACOR DIMETHYL FUMARATE (delayed release capsule) is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

Evaluation commenced: 29 Sep 2017

Registration decision: 18 Jul 2019

Date registered: 10 Jul 2021

Approval time: 254 (255 working days)

lenalidomide

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

Multiple Myeloma (MM)

LENALIDOMIDE DR.REDDY'S, LENALIDOMIDE-DRLA, LENALIDOMIDE-RZ, REDDY'S-LENALIDOMIDE (capsule) is indicated for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.

LENALIDOMIDE DR.REDDY'S, LENALIDOMIDE-DRLA, LENALIDOMIDE-RZ, REDDY'S-LENALIDOMIDE is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

LENALIDOMIDE DR.REDDY'S, LENALIDOMIDE-DRLA, LENALIDOMIDE-RZ, REDDY'S-LENALIDOMIDE in combination with dexamethasone is indicated for the treatment of multiple myeloma patients whose disease has progressed after one therapy.

Myelodysplastic Syndromes (MDS)

LENALIDOMIDE DR.REDDY'S, LENALIDOMIDE-DRLA, LENALIDOMIDE-RZ, REDDY'S-LENALIDOMIDE is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Mantle Cell Lymphoma (MCL)

LENALIDOMIDE DR.REDDY'S, LENALIDOMIDE-DRLA, LENALIDOMIDE-RZ, REDDY'S-LENALIDOMIDE is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

LACOSAMIDE SANDOZ

Evaluation commenced: 28 Sep 2018

Registration decision: 12 Jul 2019

Date registered: 6 Jul 2021

Approval time: 152 (255 working days)

lacosamide

Sandoz Pty Ltd

New generic medicine

LACOSAMIDE SANDOZ (film coated tablets) are indicated for monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.

Add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.

Paediatric patents weighing less than 50 kg should not receive Lacosamide Sandoz film-coated tablets. Paediatric patients weighing less than 50 kg should be accurately dosed on a mg/kg basis with other lacosamide products.

RIVAROXABAN SANDOZ

Evaluation commenced: 2 Jun 2020

Registration decision: 12 Mar 2021

Date registered: 6 Jul 2021

Approval time: 150 (255 working days)

rivaroxaban

Sandoz Pty Ltd

New generic medicine

RIVAROXABAN SANDOZ (film coated tablet) is indicated for:

  • Prevention of venous thromboembolism (VTE) in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks).
  • Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke.
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and for the preention of recurrent DVT and PE.

June 2021

DOPAMINE JUNO first generic

Evaluation commenced: 30 Apr 2020

Registration decision: 18 Feb 2021

Date registered: 24 Jun 2021

Approval time: 136 (255 working days)

dopamine hydrochloride

Juno Pharmaceuticals Pty Ltd

New generic medicine

DOPAMINE JUNO (concentrated injection for infusion) is indicated for the correction of haemodynamic imbalance present in:

  • Acute hypotension or shock associated with myocardial infarction, endotoxic septicaemia, trauma and renal failure.
  • As an adjunct after open heart surgery, where there is persistent hypotension after correction of hypovolaemia.
  • In chronic cardiac decompensation as in congestive failure.

METHYLPHENIDATE SANDOZ XR, METHYLPHENIDATE XR ARX

Evaluation commenced: 2 Nov 2020

Registration decision: 10 Jun 2021

Date registered: 24 Jun 2021

Approval time: 112 (175 working days)

methylphenidate hydrochloride

Teva Pharma Australia Pty Ltd

New generic medicine

METHYLPHENIDATE SANDOZ XR, METHYLPHENIDATE XR ARX (modified release tablet) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be commenced by a specialist.

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.

Need for comprehensive treatment programme

METHYLPHENIDATE SANDOZ XR, METHYLPHENIDATE XR ARX is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms.

Long term use

The effectiveness of methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. Therefore the physician who elects to use METHYLPHENIDATE SANDOZ XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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

Evaluation commenced: 31 Jul 2020

Registration decision: 12 May 2021

Date registered: 17 Jun 2021

Approval time: 151 (255 working days)

dasatinib propylene glycol

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

DASATINIB DR.REDDY'S, DASATINIB-DRLA, DASATINIB-RZ, REDDY'S-DASATINIB (tablet) is indicated for the treatment of adults aged 18 years or over with:

  • newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia integrated with chemotherapy.
  • Philadelphia chromosome positive acute lymphoblastic leukaemia with resistance or intolerance to prior therapy.

DASATINIB DR.REDDY'S, DASATINIB-DRLA, DASATINIB-RZ, REDDY'S-DASATINIB is indicated for the treatment of paediatric patients with:

  • newly diagnosed Ph+ ALL in combination with chemotherapy.

LENALIDOMIDE-TEVA, TE- LENALIDOMIDE, TE-LENALIDOMIDE first generic

Evaluation commenced: 31 Aug 2020

Registration decision: 4 Jun 2021

Date registered: 16 Jun 2021

Approval time: 146 (175 working days)

lenalidomide hydrochloride monohydrate

Teva Pharma Australia Pty Ltd

New generic medicine

Multiple Myeloma (MM)

LENALIDOMIDE-TEVA, TE- LENALIDOMIDE, TE-LENALIDOMIDE (capsule) is indicated for the treatment of multiple myeloma.

Myelodysplastic Syndromes (MDS)

LENALIDOMIDE-TEVA, TE- LENALIDOMIDE, TE-LENALIDOMIDE is indicated for treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1 risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

FLUCLOXACILLIN KABI

Evaluation commenced: 31 Aug 2020

Registration decision: 2 Jun 2021

Date registered: 7 Jun 2021

Approval time: 141 (255 working days)

flucloxacillin sodium monohydrate

Fresenius Kabi Australia Pty Ltd

New generic medicine

FLUCLOXACILLIN KABI (powder for injection) is indicated for treatment of confirmed or suspected staphylococcal infections and other Gram-positive coccal infections including pneumonia, skin and skin structure and wound infections, infected burns and cellulitis.

May 2021

ACICLOVIR AGILA, ACICLOVIR ALPHAPHARM, ACICLOVIR MYLAN

Evaluation commenced: 2 Mar 2015

Registration decision: 7 Dec 2015

Date registered: 28 May 2021

Approval time: 150 (255 working days)

aciclovir sodium

Alphapharm Pty Ltd

New generic medicine

ACICLOVIR AGILA, ACICLOVIR ALPHAPHARM, ACICLOVIR MYLAN (powder for injection) is indicated for:

  • Promoting resolution of acute clinical manifestations of mucocutaneous Herpes simplex virus infections in immunocompromised patients
  • Treatment of severe first episode primary or non-primary genital herpes in immune competent patients
  • Treatment of acute manifestations of Varicella zoster virus infection in immunocompromised patients
  • Treatment of Herpes zoster (shingles) in immune competent patients who show very severe acute local or systemic manifestations of the disease. (Benefits can be expected in patients with rash duration shorter than 72 hours. The use of the intravenous infusion may be warranted in only a small subgroup of immune competent patients with shingles)
  • Treatment of Herpes simplex encephalitis

CARMUSTINE ACCORD, CARMUSTINE INTAS

Evaluation commenced: 30 Apr 2020

Registration decision: 18 Feb 2021

Date registered: 21 May 2021

Approval time: 159 (255 working days)

carmustine

Accord Healthcare Pty Ltd

New generic medicine

CARMUSTINE ACCORD, CARMUSTINE INTAS (powder and diluent for injection) is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

  1. Malignant Glioma.
  2. Multiple Myeloma - in combination with prednisone.
  3. 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.
  4. 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.

MYCOPHENOLATE ACCORD, MYCOPHENOLATE INTAS

Evaluation commenced: 31 Jan 2020

Registration decision: 10 Nov 2020

Date registered: 18 May 2021

Approval time: 137 (255 working days)

mycophenolate mofetil

Accord Healthcare Pty Ltd

New generic medicine

MYCOPHENOLATE ACCORD, MYCOPHENOLATE INTAS (powder for injection) is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.

MYCOPHENOLATE ACCORD, MYCOPHENOLATE INTAS is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

POMALIDOMIDE JN, POMALIDOMIDE JUNO, POMOLIDE first generic

Evaluation commenced: 2 Jun 2020

Registration decision: 14 Apr 2021

Date registered: 18 May 2021

Approval time: 148 (255 working days)

pomalidomide

Juno Pharmaceuticals Pty Ltd

New generic medicine

POMALIDOMIDE JN, POMALIDOMIDE JUNO, POMOLIDE (hard capsule), in combination with bortezomib and dexamethasone, is indicated for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior treatment regimen including lenalidomide.

POMALIDOMIDE JN, POMALIDOMIDE JUNO, POMOLIDE, in combination with dexamethasone, is indicated for the treatment of patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy.

BENDAMUSTINE SANDOZ

Evaluation commenced: 31 Jul 2020

Registration decision: 29 Apr 2021

Date registered: 17 May 2021

Approval time: 145 (175 working days)

bendamustine hydrochloride monohydrate

Sandoz Pty Ltd

New generic medicine

BENDAMUSTINE SANDOZ (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 patients ineligible for autologous stem cell transplantation.
  • Relapsed/Refractory indolent Non-Hodgkin's lymphoma.

HULIO

Evaluation commenced: 2 Jun 2020

Registration decision: 7 Apr 2021

Date registered: 14 May 2021

Approval time: 172 (255 working days)

adalimumab

Alphapharm Pty Ltd

New biosimilar medicine

Rheumatoid Arthritis

HULIO (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.

HULIO can be used alone or in combination with methotrexate.

Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis

HULIO 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). HULIO can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.

Enthesitis-Related Arthritis

HULIO 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

HULIO 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

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

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

HULIO 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

HULIO 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 5.1PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS).

Psoriasis in Adults and Children

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

HULIO 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)

HULIO 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

HULIO 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.

HYDROCORTISONE PANPHARMA first generic

Evaluation commenced: 1 Apr 2019

Registration decision: 8 Apr 2021

Date registered: 12 May 2021

Approval time: 174 (255 working days)

hydrocortisone sodium succinate

Panpharma Australia Pty Ltd

New generic medicine

When oral therapy is not feasible, and the strength, form and route of administration of the drug reasonably lend the preparation to the treatment of the condition, HYDROCORTISONE PANPHARMA (powder for injection) is indicated for intravenous or intramuscular use in the following conditions:

1.Endocrine Disorders
  • Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogues may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance). Acute adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; mineralocorticoid supplements may be necessary, particularly when synthetic analogues are used).
  • Preoperatively and in the event of serious trauma or illness, in patients with known adrenal insufficiency or when adrenocortical reserve is doubtful
  • Shock unresponsive to conventional therapy if adrenocortical insufficiency exists or is suspected
  • Congenital adrenal hyperplasia
  • Nonsuppurative thyroiditis
  • Hypercalcaemia associated with cancer.
2.Rheumatic Disorders

As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in:

  • Post-traumatic osteoarthritis
  • Synovitis of osteoarthritis
  • Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy)
  • Acute and subacute bursitis
  • Epicondylitis
  • Acute nonspecific tenosynovitis
  • Acute gouty arthritis
  • Psoriatic arthritis
  • Ankylosing spondylitis.
3.Collagen Diseases

During an exacerbation or as maintenance therapy in selected cases of:

  • Systemic lupus erythematosus
  • Systemic dermatomyositis (polymyositis)
  • Acute rheumatic carditis.
4.Dermatological Diseases
  • Pemphigus
  • Severe erythema multiforme (Stevens-Johnson Syndrome)
  • Exfoliative dermatitis
  • Bullous dermatitis herpetiformis
  • Severe seborrhoeic dermatitis
  • Severe psoriasis
  • Mycosis fungoides.
5.Allergic States

Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in:

  • Bronchial asthma
  • Drug hypersensitivity reactions
  • Contact dermatitis
  • Urticarial transfusion reactions
  • Atopic dermatitis
  • Serum sickness
  • Seasonal or perennial allergic rhinitis
  • Acute noninfectious laryngeal oedema (adrenaline is the drug of first choice).
6.Ophthalmic Diseases

Severe acute and chronic allergic and inflammatory processes involving the eye, such as:

  • Herpes zoster ophthalmicus
  • Iritis, iridocyclitis
  • Chorioretinitis
  • Diffuse posterior uveitis and choroiditis
  • Optic neuritis
  • Sympathetic ophthalmia
  • Anterior segment inflammation
  • Allergic conjunctivitis
  • Allergic corneal marginal ulcers
  • Keratitis.
7.Gastrointestinal Diseases

To tide the patient over a critical period of the disease in:

  • Ulcerative colitis (systemic therapy)
  • Regional enteritis (systemic therapy).
8.Respiratory Diseases
  • Symptomatic sarcoidosis
  • Loeffler's Syndrome not manageable by other means
  • Berylliosis
  • Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy
  • Aspiration pneumonitis.
9.Haematological Disorders
  • Acquired (autoimmune) haemolytic anaemia
  • Erythroblastopenia (RBC anaemia)
  • Idiopathic thrombocytopenic purpura in adults (IV only; IM administration is contraindicated)
  • Secondary thrombocytopenia in adults
  • Congenital (erythroid) hypoplastic anaemia.
10.Neoplastic Diseases

For palliative management of:

  • Leukaemias and lymphomas in adults
  • Acute leukaemia in childhood.
11.Oedematous States
  • To induce diuresis or remission of proteinuria in the nephrotic syndrome, without uraemia, of the idiopathic type or that due to lupus erythematosus.
12.Miscellaneous
  • Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy
  • Trichinosis with neurological or myocardial involvement.

PERISYL COMBI

Evaluation commenced: 8 Mar 2011

Registration decision: 12 Oct 2011

Date registered: 12 May 2021

Approval time: 106 (255 working days)

indapamide hemihydrate; perindopril erbumine

Alphapharm Pty Ltd

New generic medicine

PERISYL COMBI 4/1.25 (tablet) is indicated for:

  • Treatment of hypertension. Treatment should not be initiated with this combination.

PERISYL COMBI 2/0.625 (tablet) is indicated for:

  • Treatment of hypertension.

PERISYL

Evaluation commenced: 23 Nov 2010

Registration decision: 2 Aug 2011

Date registered: 12 May 2021

Approval time: 150 (255 working days)

perindopril erbumine

Alphapharm Pty Ltd

New generic medicine

PERISYL (tablet) is indicated for:

  1. the treatment of hypertension
  2. the treatment of heart failure. In such patients it is recommended that perindopril be given with a diuretic and/or digoxin under close medical supervision. (The safety and efficacy of perindopril has not been demonstrated for New York Heart Association Category IV patients) and
  3. patients with established coronary artery disease (see CLINICAL TRIALS) who are stable on concomitant therapy and have no heart failure, to reduce the risk of non-fatal myocardial infarction or cardiac arrest.

ALEMBIC LACOSAMIDE, LACONAT, LACORESS, LACOSAMIDE AGH, LACOSAMIDE AGHL, LACOSAMIDE APL, LACOSAMIDE APPL, VICOMAT, VIGREN, VIMOLAC

Evaluation commenced: 31 Jul 2020

Registration decision: 4 May 2021

Date registered: 11 May 2021

Approval time: 141 (255 working days)

lacosamide

Alembic Pharmaceuticals Australia Pty Ltd

New generic medicine

ALEMBIC LACOSAMIDE, LACONAT, LACORESS, LACOSAMIDE AGH, LACOSAMIDE AGHL, LACOSAMIDE APL, LACOSAMIDE APPL, VICOMAT, VIGREN, VIMOLAC (tablet) are indicated as:

  • monotherapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
  • add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 4 years and older.

April 2021

EVEROCAN, PHARMACOR EVEROLIMUS

Evaluation commenced: 2 Jun 2020

Registration decision: 12 Apr 2021

Date registered: 21 Apr 2021

Approval time: 146 (255 working days)

everolimus

Pharmacor Pty Ltd

New generic medicine

EVEROCAN, PHARMACOR EVEROLIMUS (tablet) is indicated for the prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal or cardiac transplant and in adult patients receiving an allogeneic hepatic transplant (see section 4.4 Special warnings and precautions for use).

CIPLA DEFERASIROX, DEFERACIP, DESIROX

Evaluation commenced: 30 Jun 2020

Registration decision: 8 Apr 2021

Date registered: 21 Apr 2021

Approval time: 152 (255 working days)

deferasirox

Cipla Australia Pty Ltd

New generic medicine

CIPLA DEFERASIROX, DEFERACIP, DESIROX (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.CIPLA DEFERASIROX, DEFERACIP, DESIROX 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.

CIPLA DEFERASIROX, DEFERACIP, DESIROX is also indicated for the treatment of chronic iron overload in patients with non-transfusiondependent thalassemia syndromes aged 10 years and older.

DIMETHYL FUMARATE MSN first generic

Evaluation commenced: 31 Oct 2019

Registration decision: 9 Apr 2021

Date registered: 20 Apr 2021

Approval time: 149 (255 working days)

dimethyl fumarate

Accelagen Pty Ltd

New generic medicine

DIMETHYL FUMARATE MSN (capsule) is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

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

Evaluation commenced: 30 Jun 2020

Registration decision: 9 Apr 2021

Date registered: 15 Apr 2021

Approval time: 153 (255 working days)

daptomycin

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

DAPTOMYCIN DR.REDDY'S, DAPTOMYCIN-DRLA, DAPTOMYCIN-RZ, REDDY'S-DAPTOMYCIN (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)

Complicated Skin and Skin Structure Infections

DAPTOMYCIN DR.REDDY'S, DAPTOMYCIN-DRLA, DAPTOMYCIN-RZ, REDDY'S-DAPTOMYCIN is indicated for the treatment of adults (≥ 18 years of age) 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 DR.REDDY'S, DAPTOMYCIN-DRLA, DAPTOMYCIN-RZ, REDDY'S-DAPTOMYCIN is indicated in adults (≥ 18 years of age) 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 DR.REDDY'S, DAPTOMYCIN-DRLA, DAPTOMYCIN-RZ, REDDY'S-DAPTOMYCIN therapy has been initiated, then consideration should be given to instituting alternative antibacterial therapy (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

Paediatric patients (1 to 17 years of age)

Daptomycin is not indicated for treatment of patients less than 1 year of age (see Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE, Paediatric use).

Daptomycin has not been studied in treatment of infective endocarditis in children (see Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

Complicated Skin and Skin Structure Infections

DAPTOMYCIN DR.REDDY'S, DAPTOMYCIN-DRLA, DAPTOMYCIN-RZ, REDDY'S-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 failed on other therapy, and when caused by organisms known to be susceptible to daptomycin.

Staphylococcus aureus Bloodstream Infections (Bacteraemia)

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

VANCOMYCIN JUNO

Evaluation commenced: 31 Mar 2020

Registration decision: 23 Feb 2021

Date registered: 8 Apr 2021

Approval time: 147 (255 working days)

vancomycin hydrochloride

Juno Pharmaceuticals Pty Ltd

New generic medicine

VANCOMYCIN JUNO (powder for injection) is indicated in potentially life-threatening infections which cannot be treated with another effective, less toxic antimicrobial drug, including the penicillins and cephalosporins.

VANCOMYCIN JUNO is useful in therapy of severe staphylococcal (including methicillin-resistant staphylococcal) infections in patients who cannot receive or who failed to respond to the penicillins and cephalosporins or who have infections with staphylococci that are resistant to other antibiotics. Once sensitivity data are available, therapy should be adjusted accordingly.

VANCOMYCIN JUNO is effective alone or in combination with an aminoglycoside for endocarditis caused by S. viridans or S. bovis. For endocarditis caused by enterococci (e.g. E. faecalis), VANCOMYCIN JUNO is effective only in combination with an aminoglycoside. VANCOMYCIN JUNO is effective for the treatment of diphtheroid endocarditis. VANCOMYCIN JUNO is used in combination with rifampin, an aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by S. epidermidis or diphtheroids.

The effectiveness of VANCOMYCIN JUNO has been documented in other infections due to staphylococci including osteomyelitis, pneumonia, septicaemia, and soft tissue infections. When staphylococcal infections are localised and purulent, antibiotics are used as adjuncts to appropriate surgical measures.

Specimens for bacteriologic cultures should be obtained in order to isolate and identify causative organisms and to determine their susceptibilities to VANCOMYCIN JUNO.

VANCOMYCIN JUNO should be administered orally for the treatment of Staphylococcal enterocolitis and antibiotic associated pseudomembranous colitis produced by C. difficile. Parenteral administration of VANCOMYCIN JUNO alone is inappropriate for this indication. Vancomycin is not effective by the oral route for other types of infections. For oral administration the parenteral formulation may be used. Some systemic absorption may occur following oral administration in patients with pseudomembranous colitis.

SUGAMMADEX-DR REDDY'S, SUGAMMADEX-DRLA, SUGAMMADEX-REDDY'S, SUGAMMADEX-RZ first generic

Evaluation commenced: 30 Mar 2020

Registration decision: 6 Jan 2021

Date registered: 8 Apr 2021

Approval time: 123 (255 working days)

sugammadex sodium

Dr Reddys Laboratories Australia Pty Ltd

New generic medicine

SUGAMMADEX-DR REDDY'S, SUGAMMADEX-DRLA, SUGAMMADEX-REDDY'S, SUGAMMADEX-RZ (solution for injection) is indicated for reversal of neuromuscular blockade induced by rocuronium or vecuronium.

March 2021

APX-DIENOGEST, DIENOGEST-STR, DINASANE first generic

Evaluation commenced: 30 Jun 2020

Registration decision: 26 Mar 2021

Date registered: 30 Mar 2021

Approval time: 148 (255 working days)

dienogest

Arrow Pharma Pty Ltd

New generic medicine

APX-DIENOGEST, DIENOGEST-STR, DINASANE (tablet) is indicated for the treatment of endometriosis.

MSN DASATINIB

Evaluation commenced: 3 Jun 2020

Registration decision: 19 Mar 2021

Date registered: 25 Mar 2021

Approval time: 154 (255 working days)

dasatinib

Accelagen Pty Ltd

New generic medicine

MSN DASATINIB (tablet) is indicated for the treatment of adults aged 18 years or over with:

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

MSN DASATINIB is indicated for the treatment of paediatric patients with:

  • Ph+ CML in the chronic phase.
  • newly diagnosed Ph+ ALL in combination with chemotherapy.

COLCINE, PHARMACOR COLCHICINE first generic

Evaluation commenced: 2 Jun 2020

Registration decision: 15 Mar 2021

Date registered: 22 Mar 2021

Approval time: 149 (255 working days)

colchicine

Pharmacor Pty Ltd

New generic medicine

Relief of pain in acute gout. COLCINE, PHARMACOR COLCHICINE (tablet) should not be used unless NSAIDS are contraindicated, or have been used and found to lack analgesic efficacy or to have unacceptable side effects in the individual patient.

COLCINE, PHARMACOR COLCHICINE is not an analgesic and does not provide relief from other types of pain.

AKM DEFERASIROX FC, PHARMACOR DEFERASIROX FC

Evaluation commenced: 6 Apr 2020

Registration decision: 11 Feb 2021

Date registered: 22 Mar 2021

Approval time: 147 (255 working days)

deferasirox

Pharmacor Pty Ltd

New generic medicine

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

AKM DEFERASIROX FC, PHARMACOR DEFERASIROX FC is also indicated for the treatment of chronic iron overload in patients with nontransfusion-dependent thalassemia syndromes aged 10 years and older.

DASATINIB-TEVA, TE-DASATINIB

Evaluation commenced: 11 May 2020

Registration decision: 11 Mar 2021

Date registered: 18 Mar 2021

Approval time: 163 (175 working days)

dasatinib

Teva Pharma Australia Pty Ltd

New generic medicine

DASATINIB-TEVA, TE-DASATINI (tablet) is indicated for the treatment of adults aged 18 years or over with:

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

Dasatinib is indicated for the treatment of paediatric patients with:

  • Ph+ CML in the chronic phase.
  • newly diagnosed Ph+ ALL in combination with chemotherapy.

ICATIBANT MYLAN first generic

Evaluation commenced: 4 Mar 2019

Registration decision: 20 Dec 2019

Date registered: 12 Mar 2021

Approval time: 158 (255 working days)

icatibant

Alphapharm Pty Ltd

New generic medicine

ICATIBANT MYLAN (solution for injection) is indicated for symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase-inhibitor deficiency.

EFERAS

Evaluation commenced: 30 Apr 2020

Registration decision: 11 Feb 2021

Date registered: 12 Mar 2021

Approval time: 139 (255 working days)

deferasirox

Alphapharm Pty Ltd

New generic medicine

The treatment of chronic iron overload due to blood transfusions (transfusional haemosiderosis) in adults and paediatric patients 6 years and older. EFERAS (tablet) 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.

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

TENOFOVIR EMTRICITABINE SANDOZ first generic

Evaluation commenced: 2 Jan 2020

Registration decision: 18 Feb 2021

Date registered: 1 Mar 2021

Approval time: 172 (255 working days)

emtricitabine; tenofovir disoproxil succinate

Sandoz Pty Ltd

New generic medicine

Treatment of HIV-1 infection

TENOFOVIR, EMTRICITABINE SANDOZ (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

TENOFOVIR, EMTRICITABINE SANDOZ is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. This indication is based on clinical trials in men who have sex with men (MSM) at high risk for HIV-1 infection and in heterosexual serodiscordant couples (see section 5.1 Pharmacodynamic properties, Clinical trials).

February 2021

ALENAMI

Evaluation commenced: 31 Jul 2019

Registration decision: 22 Feb 2021

Date registered: 25 Feb 2021

Approval time: 141 (255 working days)

phentermine hydrochloride

Aspen Pharmacare Australia Pty Ltd

New generic medicine

ALENAMI (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 ALENAMI 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.

SUNITINIB SUN

Evaluation commenced: 30 Apr 2020

Registration decision: 9 Feb 2021

Date registered: 22 Feb 2021

Approval time: 149 (255 working days)

sunitinib malate

Sun Pharma ANZ Pty Ltd

New generic medicine

SUNITINIB SUN (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).

ABRILADA

Evaluation commenced: 2 Jun 2020

Registration decision: 8 Feb 2021

Date registered: 22 Feb 2021

Approval time: 148 (175 working days)

adalimumab

Pfizer Australia Pty Ltd

New biosimilar medicine

Rheumatoid Arthritis

ABRILADA (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.

ABRILADA can be used alone or in combination with methotrexate.

Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis

ABRILADA 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 antirheumatic drugs (DMARDs). ABRILADA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate

Enthesitis-Related Arthris

ABRILADA 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

ABRILADA 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

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

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

ABRILADA 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

ABRILADA 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

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

ABRILADA 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)

ABRILADA 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

ABRILADA is indicated for the treatment of non-infectious intermediate, posterior and panuveitis 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.

VARENICLINE SANDOZ first generic

Evaluation commenced: 27 Feb 2020

Registration decision: 4 Dec 2020

Date registered: 16 Feb 2021

Approval time: 141 (255 working days)

varenicline citrate

Sandoz Pty Ltd

New generic medicine

VARENICLINE SANDOZ (tablet) is indicated as an aid to smoking cessation in adults over the age of 18 years.

TIGECYCLINE ACCORD, TIGECYCLINE INTAS

Evaluation commenced: 30 Apr 2020

Registration decision: 5 Feb 2021

Date registered: 11 Feb 2021

Approval time: 142 (255 working days)

tigecycline

Accord Healthcare Pty Ltd

New generic medicine

TIGECYCLINE ACCORD, TIGECYCLINE INTAS (powder for injection) is indicated for the treatment of the following infections in adults:

  • Complicated skin and skin structure infections, including those with methicillin-resistant Staphylococcus aureus (MRSA), where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.
  • Complicated intra-abdominal infections, where there is suspected or proven resistance to, intolerance of, or there are co-morbidities preventing the use of, other available agents.

VIRUPOS

Evaluation commenced: 2 Dec 2019

Registration decision: 5 Feb 2021

Date registered: 11 Feb 2021

Approval time: 123 (255 working days)

aciclovir

AFT Pharmaceuticals Pty Ltd

New generic medicine

VIRUPOS (eye ointment) is indicated for treatment of Herpes simplex keratitis.

BORTEZOMIB ACCORD, BORTEZOMIB INTAS

Evaluation commenced: 1 May 2019

Registration decision: 8 Jul 2020

Date registered: 9 Feb 2021

Approval time: 252 (255 working days)

bortezomib

Accord Healthcare Pty Ltd

New generic medicine

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

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

APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN

Evaluation commenced: 31 Oct 2019

Registration decision: 5 Feb 2021

Date registered: 9 Feb 2021

Approval time: 147 (255 working days)

ciclosporin

Generic Partners Pty Ltd

New generic medicine

APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN (soft capsule) is indicated:

  • As an immunosuppressive agent for the prevention of graft rejection following kidney, liver and heart allogeneic transplantation.
  • For induction and/or maintenance of remission in the nephrotic syndrome. APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN is not a first-line agent. Its use should be restricted to occasions when steroids and cytostatic drugs have failed, or are not tolerated, or are considered inappropriate, and when renal function is unimpaired (see section 4.4 Special Warnings and Precautions for Use).
  • For the treatment of severe, active rheumatoid arthritis in patients for whom classical slow-acting antirheumatic agents (including methotrexate) are inappropriate or ineffective.
  • In patients with severe psoriasis in whom conventional therapy is ineffective or inappropriate and the disease has caused a significant interference with quality of life.
  • For the treatment of severe atopic dermatitis when other treatment is ineffective or inappropriate.

Careful monitoring of all ciclosporin-treated patients is mandatory. APO-CICLOSPORIN, CICLORAL, CICLOSPORIN GENPAR, CICLOSPORIN GPPL, CICLOSPORIN GXP, CICLOSPORIN-APOTEX, NELORIN, NERIN should only be used by medical practitioners who are experienced in the use of immunosuppressive therapy (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE).

CILATIL, TADALAFIL ALPHAPHARM

Evaluation commenced: 31 Oct 2013

Registration decision: 2 Sep 2014

Date registered: 3 Feb 2021

Approval time: 135 (255 working days)

tadalafil

Alphapharm Pty Ltd

New generic medicine

CILATIL,TADALAFIL ALPHAPHARM (tablet) is indicated for the treatment of:

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

January 2021

EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE

Evaluation commenced: 27 Mar 2013

Registration decision: 12 Nov 2013

Date registered: 11 Jan 2021

Approval time: 121 (255 working days)

ezetimibe; simvastatin

Alphapharm Pty Ltd

New generic medicine

Primary Hypercholesterolaemia

EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE (tablet) is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate:

  • Patients not appropriately controlled with a statin or ezetimibe alone,
  • Patients already treated with a statin and ezetimibe.
Homozygous Familial Hypercholesterolaemia (HoFH)

EZETIMIBE-SIMVASTATIN ALPHAPHARM, ZIMYBE is indicated in patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE

Evaluation commenced: 27 Mar 2013

Registration decision: 16 Oct 2013

Date registered: 11 Jan 2021

Approval time: 97 (255 working days)

ezetimibe

Alphapharm Pty Ltd

New generic medicine

Primary Hypercholesterolaemia

EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE (tablet) administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.

Homozygous Familial Hypercholesterolaemia (HoFH)

EZETIMIBE ALPHAPHARM,MYLAN-EZETIMIBE administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g., LDL apheresis).

Homozygous Sitosterolaemia (Phytosterolaemia)

EZETIMIBE ALPHAPHARM, MYLAN-EZETIMIBE is indicated for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.