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ADEC 237th meeting resolutions, 2-3 December 2004

Australian Drug Evaluation Committee

2 December 2004

Published in the Commowealth of Australia Gazette, No. GN 2, 19 January 2005

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 237th (2004/6) meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 December 2004) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that the following medicines should be approved for registration, subject to the resolution of all outstanding matters to the satisfaction of the Committee and the Therapeutic Goods Administration. These recommendations for approval may be subject to specific conditions.

NORELGESTROMIN 150µg and ETHINYLOESTRADIOL 20µg
EVRA
Transdermal drug delivery system
Janssen-Cilag Pty Ltd
New Chemical Entity: Female Contraception.

BRIMONIDINE TARTRATE 2.0mg/mL and TIMOLOL MALEATE 5.0mg/mL
COMBIGAN
Eye drops
Allergan Australia Pty Ltd
New Fixed Combination: The reduction of elevated intraocular pressure for the treatment of open angle glaucoma and/or ocular hypertension in patients not responding to monotherapy.

CINACALCET HYDROCHLORIDE 30mg, 60mg and 90mg
SENSIPAR
Tablets
Amgen Australia Pty Ltd
New Chemical Entity: Sensipar may be used to treat the biochemical manifestations of secondary hyperparathyroidism in patients with end stage renal disease receiving dialysis. Sensipar should be used as adjunctive therapy. Sensipar may be used to treat the biochemical manifestations of primary hyperparathyroidism in patients for whom parathyroidectomy is not a treatment option. There are no data at present to suggest that Sensipar produces clinically relevant benefit.

Sensipar is indicated for the treatment of hypercalcaemia in patients with parathyroid carcinoma.

METFORMIN HYDROCHLORIDE 500mg
DIABEX XR
Modified Release Tablets
Alphapharm Pty Limited
New Dose Form: For the treatment of type 2 diabetes mellitus in adults, particularly in overweight patients, when dietary management and exercise does not result in adequate glycaemic control. Diabex XR may be used as monotherapy or in combination with other oral agents, or with insulin.

INSULIN GLULISINE (Rbe) 100IU/mL
APIDRA
Solution for Injection
Aventis Pharma Pty Limited
New Chemical Entity: For the treatment of type 1 and type 2 diabetes mellitus in adults and children older than 12 years who require insulin for the control of hyperglycaemia.

ROSIGLITAZONE (as maleate) 2mg, 4mg and 8mg
AVANDIA
Tablets
GlaxoSmithKline Australia Pty Ltd
New Indication: For the treatment of type 2 diabetes mellitus in dual therapy with insulin in patients not adequately controlled by diet and exercise and where an increase in insulin dose is inappropriate.

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AMOXYCILLIN TRIHYDRATE 600mg/5mL and POTASSIUM CLAVULANATE 42.9mg/5mL
AUGMENTIN ES 600/42.9
Powder for oral suspension
GlaxoSmithKline Australia Pty Ltd
New Strength: For treatment of acute otitis media when susceptible bacterial pathogens (S. pneumoniae, H. influenzae, M. catarrhalis) are suspected or confirmed.

PEGINTERFERON ALFA-2A singly or in combination with RIBAVIRIN
PEGASYS RBV - Composite pack, containing peginterferon alfa-2a 135µg/0.5mL and ribavirin 200mg, and also peginterferon alfa-2a 185µg/0.5mL and ribavirin 200mg
PEGASYS - Solution for injection, containing peginterferon alfa-2a 135µg/0.5mL and 185µg/0.5mL (with or without) COPEGUS - Tablets, containing 200mg ribavirin; and
Roche Products Pty Limited
Change in Patient Group: To include patients suffering from chronic hepatitis C who have persistently normal levels of alanine aminotransferase (N-ALT).

AMLODIPINE MALEATE 5mg and 10mg
AMLO
Tablets
Eremad Pty Limited
New Salt: First line treatment for mild to moderate essential hypertension. It can be used as the sole agent to control blood pressure in the majority of patients. Patients not adequately controlled on a single antihypertensive agent may benefit from the addition of amlodipine, which has been used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent, or an angiotensin converting enzyme inhibitor.

First line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other antianginal drugs.

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DARIFENACIN HYDROBROMIDE 7.5mg and 15mg
ENABLEX
Modified Release Tablets
Novartis Pharmaceuticals Australia Pty Ltd.
New Chemical Entity: For the treatment of overactive bladder, with the symptoms of urgency, urge urinary incontinence or frequency.

ETANERCEPT 25mg
ENBREL
Powder for Injection and Diluent
Wyeth Australia Pty Limited
New Indication & Changes in Dosage Regimen: For the treatment of active, adult rheumatoid arthritis (RA) in patients who have had an inadequate response to one or more disease modifying antirheumatic drugs (DMARDs). Enbrel can be used in combination with methotrexate.

VALSARTAN 40mg, 80mg and 160mg and 80mg and 160mg
DIOVAN
Tablets & Capsules
Novartis Pharmaceuticals Australia Pty Ltd.
New Indication: To improve survival following myocardial infarction in clinically stable patients with signs, symptoms or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction.

PORACTANT ALFA 120mg/1.5mL and 240mg/3.0mL
CUROSURF
Suspension for intratracheal instillation
Douglas Pharmaceuticals Australia Limited
New Chemical Entity: For the treatment of respiratory distress syndrome (RDS) in premature infants and for prophylactic use in infants at risk of RDS.

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SOLVENT-DETERGENT TREATED FROZEN HUMAN PLASMA
SOLUTION 9.0 to 14.0g human plasma protein per 200mL

OCTAPLAS
Solution for Injection
Octapharma Australia Pty Limited
New Chemical Entity: For the treatment of complex deficiencies of coagulation factors such as coagulopathy due to severe hepatic failure or massive transfusion; substitution therapy in coagulation factor deficiencies in emergency situations when a specific coagulation factor concentrate, e.g. Factor V or Factor XI, is not available or when a precise laboratory diagnosis is not possible; reversal of life-threatening bleeding due to warfarin effect, in conjunction with vitamin K dependant concentrates; thrombotic thrombocytopenic purpura (TTP), usually in conjunction with plasma exchange; haemorrhage due to coagulation abnormalities resulting from intensive plasma exchange procedures.

EVEROLIMUS 0.25mg, 0.5mg, 0.75mg and 1mg and 0.1 mg and 0.25 mg
CERTICAN
Tablets and Dispersible Tablets
Novartis Pharmaceuticals Australia Pty Limited
New Chemical Entity: For the prophylaxis of organ rejection in adult patients at mild to moderate immunological risk receiving an allogeneic renal or cardiac transplant.

CETUXIMAB 2mg/mL
ERBITUX
Solution for Injection
Alphapharm Pty Limited
New Chemical Entity: For the treatment of patients with metastatic colorectal cancer that has been demonstrated to be epidermal growth factor receptor (EGFR) positive and whose disease has progressed or is refractory to irinotecan based therapy. Cetuximab can be used at the doses recommended either in combination with irinotecan or as a single agent.

RITUXIMAB (rch) 100mg and 500mg
MABTHERA
Solution for IV Infusion
Roche Products Pty Limited
New Indication: For the treatment of CD20 positive, stage 3 to 4, previously untreated, follicular, B-cell non-Hodgkin's lymphoma, in combination with chemotherapy.

OCTOCOG ALFA (rch) 250IU, 500IU, 1000IU and 1500 U
ADVATE
Powder for IV Injection
Baxter Healthcare Pty Limited
New Chemical Entity: For use in haemophilia A for prevention and control of haemorrhagic episodes. Patients with haemophilia A may be treated with Advate as perioperative management. Advate is not indicated in von Willebrand's disease

LANREOTIDE (as acetate) 60mg, 90mg and 120mg
SOMATULINE AUTOGEL
Solution for Injection
Ipsen Pty Ltd.
New Indication: Treatment of symptoms of carcinoid syndrome associated with carcinoid tumours.

LETROZOLE 2.5mg
FEMARA
Tablets
Novartis Pharmaceuticals Australia Pty Limited
New Indication: Extended adjuvant treatment of early breast cancer in post-menopausal women who have received prior standard adjuvant tamoxifen therapy. (See Clinical Trials). For all indications, efficacy has not been demonstrated in patients with hormone receptor negative disease.

BEVACIZUMAB (rch) 25mg/mL
AVASTIN and ALTUZAN
Solution for Injection
Roche Products Pty Limited
New Chemical Entity: Treatment, with 5-fluorouracil, folinic acid and irinotecan or 5-fluorouracil and folinic acid, of patients with metastatic colorectal cancer.

20 December 2004

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