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Prescription medicines: registration of new generic medicines and biosimilar medicines

24 May 2022

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, 2022

Previous years

2021 2020 2019 2018 2017

April 2022

ISOPRENALINE MACURE

Evaluation commenced: 2 Aug 2021

Registration decision: 6 Apr 2022

Date registered: 26 Apr 2022

Approval time: 107 (255 working days)

isoprenaline hydrochloride

Juno Pharmaceuticals Pty Ltd

New generic medicine

ISOPRENALINE MACURE (solution for injection) is indicated:

For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.

For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation) (see Section 4.3 Contraindications.)

For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available (see Section 4.3 Contraindications.)

For bronchospasm occurring during anaesthesia.

As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure and cardiogenic shock (see Section 4.4 Special warnings and precautions for use).

DARUNAVIR SANDOZ

Evaluation commenced: 2 Jan 2018

Registration decision: 15 Oct 2018

Date registered: 22 Apr 2022

Approval time: 106 (255 working days)

darunavir

Sandoz Pty Ltd

New generic medicine

Adult patients

DARUNAVIR SANDOZ (film-coated tablet) (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 SANDOZ (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.

ALCEPT; MOFIT; PHARMACOR MYCOPHENOLATE

Evaluation commenced: 1 Jun 2021

Registration decision: 25 Mar 2022

Date registered: 22 Apr 2022

Approval time: 126 (255 working days)

mycophenolate mofetil

Pharmacor Pty Ltd

New generic medicine

ALCEPT; MOFIT; PHARMACOR MYCOPHENOLATE (film-coated tablet) is indicated for the prophylaxis of solid organ rejection in adults receiving allogeneic organ transplants.

ALCEPT; MOFIT; PHARMACOR MYCOPHENOLATE is indicated for the prophylaxis of organ rejection in paediatric patients (2 to 18 years) receiving allogeneic renal transplants.

March 2022

LENALIDOMIDE LRX; LENALIDOMIDE LU

Evaluation commenced: 31 Mar 2021

Registration decision: 28 Mar 2022

Date registered: 30 Mar 2022

Approval time: 156 (255 working days)

lenalidomide

Luminarie Pty Ltd

New generic medicine

Multiple Myeloma (MM)

LENALIDOMIDE LRX; LENALIDOMIDE LU (capsule) is indicated for the treatment of multiple myeloma.

Myelodysplastic Syndromes (MDS)

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 is indicated for the treatment of patients with relapsed and/or refractory mantle cell lymphoma.

CIPLA DAPAGLIFLOZIN; DAPAGLICIP; FOCIPRA first generic

Evaluation commenced: 30 Jun 2021

Registration decision: 11 Mar 2022

Date registered: 30 Mar 2022

Approval time: 130 (255 working days)

dapagliflozin (as propanediol monohydrate)

Cipla Australia Pty Ltd

New generic medicine

Type 2 diabetes mellitus
Glycaemic control

CIPLA DAPAGLIFLOZIN; DAPAGLICIP; FOCIPRA (film-coated tablet) is indicated in adults with type 2 diabetes mellitus:

  • as monotherapy as an adjunct to diet and exercise in patients for whom metformin is otherwise indicated but was not tolerated.
  • as initial combination therapy with metformin, as an adjunct to diet and exercise, to improve glycaemic control when diet and exercise have failed to provide adequate glycaemic control and there are poor prospects for response to metformin monotherapy(for example, high initial haemoglobin A1c [HbA1c] levels).
  • in combination with other anti-hyperglycaemic agents to improve glycaemic control, when these together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 Pharmacodynamic properties - clinical trials and section 4.4 Special warnings and precautions for use for available data on different add-on combination therapies).
Prevention of hospitalisation for heart failure

CIPLA DAPAGLIFLOZIN; DAPAGLICIP; FOCIPRA is indicated in adults with type 2 diabetes mellitus and established cardiovascular disease or risk factors for cardiovascular disease to reduce the risk of hospitalization for heart failure (see section 5.1 Pharmacodynamic properties - clinical trials).

Heart failure

CIPLA DAPAGLIFLOZIN; DAPAGLICIP; FOCIPRA is indicated in adults for the treatment of symptomatic heart failure with reduced ejection fraction, as an adjunct to standard of care therapy (see section 5.1 Pharmacodynamic properties).

Chronic kidney disease

CIPLA DAPAGLIFLOZIN; DAPAGLICIP; FOCIPRA is indicated to reduce the risk of progressive decline in kidney function in adults with proteinuric chronic kidney disease (CKD Stage 2, 3 or 4 and urine ACR ≥30 mg/g)

ESTRO-PESS first generic

Evaluation commenced: 31 Jul 2020

Registration decision: 27 Jul 2021

Date registered: 30 Mar 2022

Approval time: 186 (255 working days)

estradiol (as hemihydrate)

Aspen Pharmacare Australia Pty Ltd

New generic medicine

ESTRO-PESS (modified-release pessary) is indicated for the treatment of atrophic vaginitis due to estrogen deficiency in postmenopausal women.

ESTRO-PESS is not intended for children or males.

ADIMEDI PREGABALIN; ADIMIS PREGABALIN; ADIRAG PREGABALIN; ADIRAMEDICA PREGABALIN; ADIRIS PREGABALIN; ADRABALIN PREGABALIN; ADRANURO PREGABALIN; ADRAPREGA PREGABALIN

Evaluation commenced: 24 Feb 2021

Registration decision: 7 Mar 2022

Date registered: 28 Mar 2022

Approval time: 148 (255 working days)

pregabalin

AdiraMedica Pty Ltd

New generic medicine

ADIMEDI PREGABALIN; ADIMIS PREGABALIN; ADIRAG PREGABALIN; ADIRAMEDICA PREGABALIN; ADIRIS PREGABALIN; ADRABALIN PREGABALIN; ADRANURO PREGABALIN; ADRAPREGA PREGABALIN (capsule) is indicated for the treatment of neuropathic pain in adults.

Pregabalin is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.

YUFLYMA

Evaluation commenced: 1 Jun 2021

Registration decision: 28 Feb 2022

Date registered: 25 Mar 2022

Approval time: 165 (255 working days)

adalimumab

Celltrion Healthcare Australia Pty Ltd

New biosimilar medicine

Rheumatoid Arthritis

YUFLYMA (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.

YUFLYMA can be used alone or in combination with methotrexate.

Juvenile Idiopathic Arthritis

Polyarticular Juvenile Idiopathic Arthritis

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

Enthesitis-Related Arthritis

YUFLYMA 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

YUFLYMA 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

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

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

YUFLYMA 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

YUFLYMA 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

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

YUFLYMA 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)

YUFLYMA 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

YUFLYMA 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.

CIPLA ISOPRENALINE; ISOCIP; ISOCIPRALINE

Evaluation commenced: 31 Mar 2021

Registration decision: 18 Mar 2022

Date registered: 24 Mar 2022

Approval time: 160 (255 working days)

isoprenaline hydrochloride

Cipla Australia Pty Ltd

New generic medicine

CIPLA ISOPRENALINE; ISOCIP; ISOCIPRALINE (solution for injection) is indicated:

  • For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
  • For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation) (see section 4.3 Contraindications).
  • For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available (see section 4.3 Contraindications).
  • For bronchospasm occurring during anaesthesia.
  • As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure and cardiogenic shock (see section 4.4 Special warnings and precautions for use).

FYZANT

Evaluation commenced: 31 Mar 2021

Registration decision: 25 Jan 2022

Date registered: 18 Mar 2022

Approval time: 120 (255 working days)

icatibant (as acetate)

Juno Pharmaceuticals Pty Ltd

New generic medicine

FYZANT (solution for injection) is 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.

PIRFENIDONE SANDOZ first generic

Evaluation commenced: 30 Apr 2021

Registration decision: 9 Feb 2022

Date registered: 16 Mar 2022

Approval time: 123 (255 working days)

pirfenidone

Sandoz Pty Ltd

New generic medicine

PIRFENIDONE SANDOZ (tablet) is indicated for the treatment of idiopathic pulmonary fibrosis (IPF)

ANIDULAFUNGIN GX; ANIDULAFUNGIN GA; ANIDULAFUNGIN ISL; ANIDULAFUNGIN JUNO; ANIDULAFUNGIN MEDIS; ANIDULAFUNGIN ZP first generic

Evaluation commenced: 1 Mar 2021

Registration decision: 6 Jan 2022

Date registered: 11 Mar 2022

Approval time: 127 (255 working days)

anidulafungin

Medis Pharma Pty Ltd

New generic medicine

ANIDULAFUNGIN GX; ANIDULAFUNGIN GA; ANIDULAFUNGIN ISL; ANIDULAFUNGIN JUNO; ANIDULAFUNGIN MEDIS; ANIDULAFUNGIN ZP (powder for injection) is indicated as a treatment of invasive candidiasis, including candidaemia in adult and in paediatric patients one month and older (see Section 5.1 Pharmacodynamic Properties).

DEFERASIROX FCT MSN

Evaluation commenced: 1 Jun 2021

Registration decision: 3 Mar 2022

Date registered: 10 Mar 2022

Approval time: 124 (255 working days)

deferasirox

Accelagen Pty Ltd

New generic medicine

DEFERASIROX FCT MSN (film-coated 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.

PFIZER DAPTOMYCIN

Evaluation commenced: 6 Sep 2021

Registration decision: 1 Mar 2022

Date registered: 8 Mar 2022

Approval time: 81 (255 working days)

daptomycin

Pfizer Australia Pty Ltd

New generic medicine

PFIZER 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)

PFIZER 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)

PFIZER 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 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

PFIZER 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)

PFIZER 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.

AMBRISENTAN MSN

Evaluation commenced: 17 Jun 2021

Registration decision: 4 Mar 2022

Date registered: 8 Mar 2022

Approval time: 136 (255 working days)

ambrisentan

Accelagen Pty Ltd

New generic medicine

AMBRISENTAN MSN (film-coated tablet) is indicated for the treatment of:

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

    CYCLOPHOSPHAMIDE ACCORD; CYCLOPHOSPHAMIDE INTAS first generic

    Evaluation commenced: 1 Jun 2021

    Registration decision: 2 Mar 2022

    Date registered: 7 Mar 2022

    Approval time: 148 (255 working days)

    cyclophosphamide (as monohydrate)

    Accord Healthcare Pty Ltd

    New generic medicine

    The proper use of CYCLOPHOSPHAMIDE ACCORD; CYCLOPHOSPHAMIDE INTAS (powder for injection) requires accurate diagnosis, careful assessment of the anatomic extent of the disease, knowledge of the type and effects of any previous therapy, and continued evaluation of the patient's general and haematologic status. It is essential that adequate clinical and laboratory facilities be available for proper monitoring of patients during treatment with cyclophosphamide.

    The clinical course of the disease should be recorded in objective terms before treatment is begun and thereafter at regular intervals. Careful management of patients receiving cyclophosphamide will help achieve maximum benefit with minimum risk.

    Antineoplastic properties

    Patients with neoplasms that might preferably be treated by surgical and/or irradiation procedures should ordinarily not be treated by chemotherapy alone.

    The following classification is a guide to the various neoplastic conditions in which benefit may be derived from chemotherapy with cyclophosphamide:

    Frequently responsive myeloproliferative and lymphoproliferative disorders:

    Malignant lymphomas including Hodgkins (stages III and IV, Peter's Staging System*) and non-Hodgkins lymphomas; multiple myeloma; leukaemias; mycosis fungoides (advanced disease).

    *Modified as the International Staging Classification for Hodgkin's Disease in 'Report of the committee on the Staging of Hodgkin's Disease'. Cancer Res 26:1310, 1966.

    • Stage I: Disease limited to one anatomic region (Stage I) or two contiguous anatomic regions (Stage I2) on the same side of the diaphragm.
    • Stage II: Disease in more than two anatomic regions or two contiguous regions on the same side of the diaphragm.
    • Stage III: Disease on both sides of the diaphragm, but not extending beyond the involvement of lymph nodes, spleen, and/or Waldeyer's ring.
    • Stage IV: Involvement of the bone marrow, lung parenchyma, pleura, liver, bone, skin, kidneys, gastrointestinal tract, or in any tissue or organ in addition to lymph nodes, spleen or Waldeyer's ring.

    All stages are subclassified as A or B to indicate the absence or presence, respectively, of systemic symptoms.

    Frequently responsive solid malignancies:

    Neuroblastoma (patients with disseminated disease); adenocarcinoma of the ovary, retinoblastoma.

    Infrequently responsive malignancies:

    Carcinoma of the breast; malignant neoplasms of the lung.

    Immunosuppressive properties

    Cyclophosphamide has also been used in the treatment of autoimmune diseases and immunopathies of unspecified type (i.e. Wegener's granulomatosis) when these diseases have been resistant to conventional first and second line of treatment, and for the prevention of transplant rejection. Cyclophosphamide can be recommended for use in treatment of nonmalignancies only when in the opinion of the physician the benefits to the patient outweigh the risk of treatment with cyclophosphamide.

    OSMIVIR; OSELTAMIVIR STR; OSELTAMIVIR STRIDES

    Evaluation commenced: 2 Mar 2020

    Registration decision: 8 Jan 2021

    Date registered: 4 Mar 2022

    Approval time: 148 (255 working days)

    oseltamivir (as phosphate)

    Strides Pharma Science Pty Ltd

    New generic medicine

    OSMIVIR; OSELTAMIVIR STR; OSELTAMIVIR STRIDES (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.

    OSMIVIR; OSELTAMIVIR STR; OSELTAMIVIR STRIDES 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.

    TOBETA-XL; TOPRELOC-XL

    Evaluation commenced: 3 May 2021

    Registration decision: 25 Feb 2022

    Date registered: 4 Mar 2022

    Approval time: 190 (255 working days)

    metoprolol/metoprolol succinate

    Pharmacor Pty Ltd

    New generic medicine

    TOBETA-XL; TOPRELOC-XL (modified release tablet) is indicated as a treatment for stable, chronic heart failure as an adjunct to other heart failure therapy.

    LEVETIRACETAM MEDICIANZ; LEVETIRACETAM MEDSURGE

    Evaluation commenced: 2 Jun 2020

    Registration decision: 28 Feb 2022

    Date registered: 4 Mar 2022

    Approval time: 152 (255 working days)

    levetiracetam

    Medicianz Healthcare Pty Ltd

    New generic medicine

    LEVETIRACETAM MEDICIANZ; LEVETIRACETAM MEDSURGE concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

    Levetiracetam concentrate solution for IV infusion is indicated for:

    • Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation.
    • Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.
    • Add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME).
    • Add on therapy in the treatment of primary generalised tonic-clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).

    MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX

    Evaluation commenced: 1 Jun 2021

    Registration decision: 25 Feb 2022

    Date registered: 3 Mar 2022

    Approval time: 143 (255 working days)

    rosuvastatin (as calcium)

    Medreich Australia Pty Ltd

    New generic medicine

    MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX (film-coated tablet) should be used as an adjunct to diet when the response to diet and exercise is inadequate.

    Prevention of cardiovascular events

    MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX is indicated for prevention of major cardiovascular events in men ≥50 years old and women ≥60 years old with no clinically evident cardiovascular disease but with at least two conventional risk factors for cardiovascular disease (hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease). MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX is indicated to:

    • Reduce the risk of nonfatal myocardial infarction
    • Reduce the risk of nonfatal stroke
    • Reduce the risk of coronary artery revascularisation procedures.
    In patients with hypercholesterolaemia

    MEDREICH ROSUVASTATIN; ROSUVASTATIN MA; ROSUVASTATIN MC; ROSUVASTATIN ME; ROSUVASTATIN MRX is indicated for the treatment of hypercholesterolaemia (including familial hypercholesterolaemia).

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

    February 2022

    ISOPRENALINE HYDROCHLORIDE MEDICIANZ; ISOPRENALINE HYDROCHLORIDE MEDSURGE; ISOPRIKA; ISOPRILINE first generic

    Evaluation commenced: 5 May 2021

    Registration decision: 1 Feb 2022

    Date registered: 10 Feb 2022

    Approval time: 156 (255 working days)

    isoprenaline hydrochloride

    Micro Labs Pty Ltd

    New generic medicine

    ISOPRENALINE HYDROCHLORIDE MEDICIANZ; ISOPRENALINE HYDROCHLORIDE MEDSURGE; ISOPRIKA; ISOPRILINE (solution for injection) is indicated:

    • For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
    • For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation) (see Section 4.3 Contraindications)
    • For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available (see Section 4.3 Contraindications.)
    • For bronchospasm occurring during anaesthesia.
    • As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure and cardiogenic shock (see Section 4.4 Special warnings and precautions for use).

    ISOPRENALINE HYDROCHLORIDE MEDICIANZ; ISOPRENALINE HYDROCHLORIDE MEDSURGE; ISOPRIKA; ISOPRILINE first generic

    Evaluation commenced: 5 May 2021

    Registration decision: 1 Feb 2022

    Date registered: 10 Feb 2022

    Approval time: 156 (255 working days)

    isoprenaline hydrochloride

    Micro Labs Pty Ltd

    New generic medicine

    ISOPRENALINE HYDROCHLORIDE MEDICIANZ; ISOPRENALINE HYDROCHLORIDE MEDSURGE; ISOPRIKA; ISOPRILINE (solution for injection) is indicated:

    • For mild or transient episodes of heart block that do not require electric shock or pacemaker therapy.
    • For serious episodes of heart block and Adams-Stokes attacks (except when caused by ventricular tachycardia or fibrillation) (see Section 4.3 Contraindications)
    • For use in cardiac arrest until electric shock or pacemaker therapy, the treatments of choice, are available (see Section 4.3 Contraindications.)
    • For bronchospasm occurring during anaesthesia.
    • As an adjunct to fluid and electrolyte replacement therapy and the use of other drugs and procedures in the treatment of hypovolaemic and septic shock, low cardiac output (hypoperfusion) states, congestive heart failure and cardiogenic shock (see Section 4.4 Special warnings and precautions for use).

    LACOSACOR; LACOVIM; PHARMACOR LACOSAMIDE; VIMCOSA

    Evaluation commenced: 1 Mar 2021

    Registration decision: 10 Dec 2021

    Date registered: 8 Feb 2022

    Approval time: 152 (255 working days)

    lacosamide

    Pharmacor Pty Ltd

    New generic medicine

    LACOSACOR; LACOVIM; PHARMACOR LACOSAMIDE; VIMCOSA (film-coated tablet) are indicated as:

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

    LACOSACOR; LACOVIM; PHARMACOR LACOSAMIDE; VIMCOSA

    Evaluation commenced: 1 Mar 2021

    Registration decision: 10 Dec 2021

    Date registered: 8 Feb 2022

    Approval time: 152 (255 working days)

    lacosamide

    Pharmacor Pty Ltd

    New generic medicine

    LACOSACOR; LACOVIM; PHARMACOR LACOSAMIDE; VIMCOSA (film-coated tablet) are indicated as:

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

    CEFAZOLIN-AFT

    Evaluation commenced: 30 Apr 2021

    Registration decision: 3 Feb 2022

    Date registered: 7 Feb 2022

    Approval time: 121 (255 working days)

    cefazolin sodium

    AFT Pharmaceuticals Pty Ltd

    New generic medicine

    CEFAZOLIN-AFT (powder for injection) is indicated for treatment of the following serious infections due to susceptible organisms:

    • Respiratory tract infections due to Strep. pneumoniae, Klebsiella sp., H. influenzae, Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present.
    • Genitourinary tract infections due to E. coli, P. mirabilis, Klebsiella sp. and some strains of enterobacter and enterococci.
    • Skin and skin structure infections due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic Streptococci and other strains of Streptococci.
    • Bone and joint infections due to Staph. aureus.
    • Septicaemia due to Strep. pneumoniae, Staph. aureus (penicillin sensitive and penicillin resistant), P. mirabilis, E. coli and Klebsiella sp.
    • Endocarditis due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic streptococci.
    • Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

    CEFAZOLIN-AFT

    Evaluation commenced: 30 Apr 2021

    Registration decision: 3 Feb 2022

    Date registered: 7 Feb 2022

    Approval time: 121 (255 working days)

    cefazolin sodium

    AFT Pharmaceuticals Pty Ltd

    New generic medicine

    CEFAZOLIN-AFT (powder for injection) is indicated for treatment of the following serious infections due to susceptible organisms:

    • Respiratory tract infections due to Strep. pneumoniae, Klebsiella sp., H. influenzae, Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available at present.
    • Genitourinary tract infections due to E. coli, P. mirabilis, Klebsiella sp. and some strains of enterobacter and enterococci.
    • Skin and skin structure infections due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic Streptococci and other strains of Streptococci.
    • Bone and joint infections due to Staph. aureus.
    • Septicaemia due to Strep. pneumoniae, Staph. aureus (penicillin sensitive and penicillin resistant), P. mirabilis, E. coli and Klebsiella sp.
    • Endocarditis due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic streptococci.
    • Appropriate culture and susceptibility studies should be performed to determine susceptibility of the causative organism to cefazolin.

    PRUCALOPRIDE MEDICIANZ; PRUCALOPRIDE MEDSURGE; ROSPRIDE first generic

    Evaluation commenced: 30 Apr 2021

    Registration decision: 2 Feb 2022

    Date registered: 4 Feb 2022

    Approval time: 155 (255 working days)

    prucalopride succinate

    Medicianz Healthcare Pty Ltd

    New generic medicine

    PRUCALOPRIDE MEDICIANZ; PRUCALOPRIDE MEDSURGE; ROSPRIDE (tablet) is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.

    • Before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.
    • If treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

      PRUCALOPRIDE MEDICIANZ; PRUCALOPRIDE MEDSURGE; ROSPRIDE first generic

      Evaluation commenced: 30 Apr 2021

      Registration decision: 2 Feb 2022

      Date registered: 4 Feb 2022

      Approval time: 155 (255 working days)

      prucalopride succinate

      Medicianz Healthcare Pty Ltd

      New generic medicine

      PRUCALOPRIDE MEDICIANZ; PRUCALOPRIDE MEDSURGE; ROSPRIDE (tablet) is indicated for the treatment of chronic functional constipation in adults in whom laxatives fail to provide adequate relief.

      • Before prucalopride is considered patients must have tried at least two different types of laxatives from different classes (at the highest tolerated recommended doses) for at least six months, but have not had adequate relief from constipation.
      • If treatment with prucalopride is not effective within four weeks, the benefit of continuing treatment should be reconsidered.

        LACOSAMIDE MSN

        Evaluation commenced: 7 May 2021

        Registration decision: 20 Jan 2022

        Date registered: 1 Feb 2022

        Approval time: 130 (255 working days)

        lacosamide

        Accelagen Pty Ltd

        New generic medicine

        LACOSAMIDE MSN (tablet) is indicated as:

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

        LACOSAMIDE MSN

        Evaluation commenced: 7 May 2021

        Registration decision: 20 Jan 2022

        Date registered: 1 Feb 2022

        Approval time: 130 (255 working days)

        lacosamide

        Accelagen Pty Ltd

        New generic medicine

        LACOSAMIDE MSN (tablet) is indicated as:

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

        January 2022

        CISATRACURIUM MYLAN

        Evaluation commenced: 31 Mar 2016

        Registration decision: 4 Apr 2017

        Date registered: 19 Jan 2022

        Approval time: 211 (255 working days)

        cisatracurium besilate

        Alphapharm Pty Ltd

        New generic medicine

        CISATRACURIUM MYLAN (solution for injection) is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.

        CISATRACURIUM MYLAN

        Evaluation commenced: 31 Mar 2016

        Registration decision: 4 Apr 2017

        Date registered: 19 Jan 2022

        Approval time: 211 (255 working days)

        cisatracurium besilate

        Alphapharm Pty Ltd

        New generic medicine

        CISATRACURIUM MYLAN (solution for injection) is indicated for use during surgical and other procedures and in intensive care to relax skeletal muscles, and to facilitate tracheal intubation and mechanical ventilation. It is used as an adjunct to general anaesthesia, or sedation in the intensive care unit.

        TECARINI; TELMISARTAN/AMLODIPINE MYLAN

        Evaluation commenced: 31 Mar 2015

        Registration decision: 21 Jan 2016

        Date registered: 19 Jan 2022

        Approval time: 162 (255 working days)

        telmisartan; amlodipine besilate

        Alphapharm Pty Ltd

        New generic medicine

        TECARINI; TELMISARTAN/AMLODIPINE MYLAN (film-coated tablet) is approved for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see dosage and administration).

        TECARINI; TELMISARTAN/AMLODIPINE MYLAN

        Evaluation commenced: 31 Mar 2015

        Registration decision: 21 Jan 2016

        Date registered: 19 Jan 2022

        Approval time: 162 (255 working days)

        telmisartan; amlodipine besilate

        Alphapharm Pty Ltd

        New generic medicine

        TECARINI; TELMISARTAN/AMLODIPINE MYLAN (film-coated tablet) is approved for the treatment of hypertension. Treatment should not be initiated with this fixed-dose combination (see dosage and administration).

        ESOMEPRAZOLE IV MYLAN

        Evaluation commenced: 29 Feb 2016

        Registration decision: 2 Mar 2017

        Date registered: 14 Jan 2022

        Approval time: 210 (255 working days)

        esomeprazole sodium

        Alphapharm Pty Ltd

        New generic medicine

        ESOMEPRAZOLE IV MYLAN (powder for injection) is indicated for the short-term management of Gastro-Oesophageal Reflux Disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate.

        Prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers.

        Short-term management in patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy when oral therapy is inappropriate:

        • healing of gastric ulcers associated with NSAID therapy
        • prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk

        ESOMEPRAZOLE IV MYLAN should be replaced with oral therapy as soon as practicable.

        FLUOROURACIL AGILA; FLUOROURACIL ALPHAPHARM; FLUOROURACIL MYLAN

        Evaluation commenced: 2 Mar 2015

        Registration decision: 16 May 2016

        Date registered: 14 Jan 2022

        Approval time: 254 (255 working days)

        fluorouracil

        Alphapharm Pty Ltd

        New generic medicine

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

        Fluorouracil should only be used when other proven measures have failed or are considered impractical.

        GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN

        Evaluation commenced: 2 Mar 2015

        Registration decision: 10 Dec 2015

        Date registered: 14 Jan 2022

        Approval time: 155 (255 working days)

        ganciclovir

        Alphapharm Pty Ltd

        New generic medicine

        GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN (ganciclovir) (powder for injection) administered as the IV infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (CMV) disease in AIDS and other severely immunocompromised individuals. It is indicated for the treatment of confirmed CMV pneumonitis in bone marrow transplant patients. It is also indicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease.

        Note: GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN (ganciclovir) is not indicated for congenital or neonatal CMV disease; nor for the treatment of CMV infection in non-immunocompromised individuals.

        NORADRENALINE MYLAN

        Evaluation commenced: 4 Jan 2018

        Registration decision: 2 Nov 2018

        Date registered: 14 Jan 2022

        Approval time: 166 (255 working days)

        noradrenaline (norepinephrine) acid tartrate monohydrate

        Alphapharm Pty Ltd

        New generic medicine

        NORADRENALINE MYLAN (concentrated injection) is indicated for the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion and drug reactions).

        As an adjunct in the treatment of cardiac arrest. To restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means.

        PANTOPRAZOLE IV ALPHAPHARM; PANTOPRAZOLE IV MYLAN

        Evaluation commenced: 31 Mar 2016

        Registration decision: 11 Jan 2017

        Date registered: 14 Jan 2022

        Approval time: 150 (255 working days)

        pantoprazole sodium sesquihydrate

        Alphapharm Pty Ltd

        New generic medicine

        PANTOPRAZOLE IV ALPHAPHARM; PANTOPRAZOLE IV MYLAN (powder for injection) is indicated for short-term use where oral therapy is not appropriate for:

        1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:

        • Duodenal ulcer
        • Gastric ulcer
        • Reflux oesophagitis
        • Gastrointestinal lesions refractory to H2 blockers
        • Zollinger-Ellison Syndrome

        2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.

        Note: patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.

        VORICONAZOLE MYLAN

        Evaluation commenced: 2 Jan 2018

        Registration decision: 5 Oct 2018

        Date registered: 14 Jan 2022

        Approval time: 106 (255 working days)

        voriconazole

        Alphapharm Pty Ltd

        New generic medicine

        VORICONAZOLE MYLAN (powder for injection) is indicated for treatment of the following fungal infections:

        • Invasive aspergillosis.
        • Serious Candida infections (including C. kruse), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
        • Serious fungal infections caused by Scedosporium spp and Fusarium spp.
        • Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.
        • Prophylaxis in patients who are at high risk of developing invasive fungal infections.

        The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

        VORICONAZOLE MYLAN

        Evaluation commenced: 2 Jan 2018

        Registration decision: 5 Oct 2018

        Date registered: 14 Jan 2022

        Approval time: 106 (255 working days)

        voriconazole

        Alphapharm Pty Ltd

        New generic medicine

        VORICONAZOLE MYLAN (powder for injection) is indicated for treatment of the following fungal infections:

        • Invasive aspergillosis.
        • Serious Candida infections (including C. kruse), including oesophageal and systemic Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
        • Serious fungal infections caused by Scedosporium spp and Fusarium spp.
        • Other serious fungal infections, in patients intolerant of, or refractory to, other therapy.
        • Prophylaxis in patients who are at high risk of developing invasive fungal infections.

        The indication is based on studies including patients undergoing haematopoietic stem cell transplantation.

        PANTOPRAZOLE IV ALPHAPHARM; PANTOPRAZOLE IV MYLAN

        Evaluation commenced: 31 Mar 2016

        Registration decision: 11 Jan 2017

        Date registered: 14 Jan 2022

        Approval time: 150 (255 working days)

        pantoprazole sodium sesquihydrate

        Alphapharm Pty Ltd

        New generic medicine

        PANTOPRAZOLE IV ALPHAPHARM; PANTOPRAZOLE IV MYLAN (powder for injection) is indicated for short-term use where oral therapy is not appropriate for:

        1. Symptomatic improvement and healing of gastrointestinal diseases which require a reduction in acid secretion:

        • Duodenal ulcer
        • Gastric ulcer
        • Reflux oesophagitis
        • Gastrointestinal lesions refractory to H2 blockers
        • Zollinger-Ellison Syndrome

        2. Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.

        Note: patients whose gastric or duodenal ulceration is not associated with ingestion of non-steroidal anti-inflammatory drugs require treatment with anti-microbial agents in addition to anti-secretory drugs, whether on first presentation or recurrence.

        NORADRENALINE MYLAN

        Evaluation commenced: 4 Jan 2018

        Registration decision: 2 Nov 2018

        Date registered: 14 Jan 2022

        Approval time: 166 (255 working days)

        noradrenaline (norepinephrine) acid tartrate monohydrate

        Alphapharm Pty Ltd

        New generic medicine

        NORADRENALINE MYLAN (concentrated injection) is indicated for the restoration of blood pressure in certain acute hypotensive states (e.g. phaeochromocytomectomy, sympathectomy, poliomyelitis, spinal anaesthesia, myocardial infarction, septicaemia, blood transfusion and drug reactions).

        As an adjunct in the treatment of cardiac arrest. To restore and maintain an adequate blood pressure after an effective heartbeat and ventilation have been established by other means.

        GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN

        Evaluation commenced: 2 Mar 2015

        Registration decision: 10 Dec 2015

        Date registered: 14 Jan 2022

        Approval time: 155 (255 working days)

        ganciclovir

        Alphapharm Pty Ltd

        New generic medicine

        GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN (ganciclovir) (powder for injection) administered as the IV infusion is indicated for the palliative treatment of confirmed sight-threatening cytomegalovirus (CMV) disease in AIDS and other severely immunocompromised individuals. It is indicated for the treatment of confirmed CMV pneumonitis in bone marrow transplant patients. It is also indicated for the prophylaxis of CMV infection and disease following bone marrow and solid organ transplantation in patients at risk of CMV disease.

        Note: GANCICLOVIR AGILA; GANCICLOVIR ALPHAPHARM; GANCICLOVIR MYLAN (ganciclovir) is not indicated for congenital or neonatal CMV disease; nor for the treatment of CMV infection in non-immunocompromised individuals.

        FLUOROURACIL AGILA; FLUOROURACIL ALPHAPHARM; FLUOROURACIL MYLAN

        Evaluation commenced: 2 Mar 2015

        Registration decision: 16 May 2016

        Date registered: 14 Jan 2022

        Approval time: 254 (255 working days)

        fluorouracil

        Alphapharm Pty Ltd

        New generic medicine

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

        Fluorouracil should only be used when other proven measures have failed or are considered impractical.

        ESOMEPRAZOLE IV MYLAN

        Evaluation commenced: 29 Feb 2016

        Registration decision: 2 Mar 2017

        Date registered: 14 Jan 2022

        Approval time: 210 (255 working days)

        esomeprazole sodium

        Alphapharm Pty Ltd

        New generic medicine

        ESOMEPRAZOLE IV MYLAN (powder for injection) is indicated for the short-term management of Gastro-Oesophageal Reflux Disease (GORD) in patients with oesophagitis and/or severe symptoms of reflux as an alternative when oral therapy is inappropriate.

        Prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers.

        Short-term management in patients requiring continued non-steroidal anti-inflammatory drug (NSAID) therapy when oral therapy is inappropriate:

        • healing of gastric ulcers associated with NSAID therapy
        • prevention of gastric and duodenal ulcers associated with NSAID therapy, in patients at risk

        ESOMEPRAZOLE IV MYLAN should be replaced with oral therapy as soon as practicable.

        SILDENAFIL GH; SILDENAFIL LAPL; SILDENAFIL LUPIN

        Evaluation commenced: 31 Mar 2021

        Registration decision: 23 Dec 2021

        Date registered: 13 Jan 2022

        Approval time: 147 (255 working days)

        sildenafil citrate

        Generic Health Pty Ltd

        New generic medicine

        SILDENAFIL GH; SILDENAFIL LAPL; SILDENAFIL LUPIN (film-coated tablet) is indicated for the treatment of erectile dysfunction in adult males. SILDENAFIL GH; SILDENAFIL LAPL; SILDENAFIL LUPIN is not indicated for use by women.

        SILDENAFIL GH; SILDENAFIL LAPL; SILDENAFIL LUPIN

        Evaluation commenced: 31 Mar 2021

        Registration decision: 23 Dec 2021

        Date registered: 13 Jan 2022

        Approval time: 147 (255 working days)

        sildenafil citrate

        Generic Health Pty Ltd

        New generic medicine

        SILDENAFIL GH; SILDENAFIL LAPL; SILDENAFIL LUPIN (film-coated tablet) is indicated for the treatment of erectile dysfunction in adult males. SILDENAFIL GH; SILDENAFIL LAPL; SILDENAFIL LUPIN is not indicated for use by women.

        ATOMED; ATORSTAT; ATORVASTATIN MLPL; TORMED

        Evaluation commenced: 1 Mar 2021

        Registration decision: 8 Dec 2021

        Date registered: 13 Jan 2022

        Approval time: 146 (255 working days)

        atorvastatin calcium trihydrate

        Micro Labs Pty Ltd

        New generic medicine

        ATOMED; ATORSTAT; ATORVASTATIN MLPL; TORMED (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, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.

        Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see section 5.1, Pharmacodynamic properties, clinical trials, prevention of cardiovascular disease) 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.

        ATOMED; ATORSTAT; ATORVASTATIN MLPL; TORMED

        Evaluation commenced: 1 Mar 2021

        Registration decision: 8 Dec 2021

        Date registered: 13 Jan 2022

        Approval time: 146 (255 working days)

        atorvastatin calcium trihydrate

        Micro Labs Pty Ltd

        New generic medicine

        ATOMED; ATORSTAT; ATORVASTATIN MLPL; TORMED (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, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.

        Atorvastatin is indicated in hypertensive patients with multiple risk factors for coronary heart disease (CHD) which may include diabetes, history of stroke or other cerebrovascular disease, peripheral vascular disease or existing asymptomatic CHD (see section 5.1, Pharmacodynamic properties, clinical trials, prevention of cardiovascular disease) 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.

        GLATIRAMER VIATRIS

        Evaluation commenced: 18 Nov 2020

        Registration decision: 8 Dec 2021

        Date registered: 4 Jan 2022

        Approval time: 163 (255 working days)

        glatiramer acetate

        Alphapharm Pty Ltd

        New generic medicine

        GLATIRAMER VIATRIS (solution for injection) is indicated for the reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis.

        Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

        GLATIRAMER VIATRIS

        Evaluation commenced: 18 Nov 2020

        Registration decision: 8 Dec 2021

        Date registered: 4 Jan 2022

        Approval time: 163 (255 working days)

        glatiramer acetate

        Alphapharm Pty Ltd

        New generic medicine

        GLATIRAMER VIATRIS (solution for injection) is indicated for the reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis.

        Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.