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ADEC 265th meeting resolutions, 7 August 2009

Australian Drug Evaluation Committee

7 August 2009

Published in the Commonwealth of Australia Gazette, No. GN 35, 9 September 2009

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 265th (2009/4) meeting of the Australian Drug Evaluation Committee (ADEC) (7 August 2009) 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.

RESOLUTION 9313

ADEC recommends approval of the submission from AstraZeneca Pty Ltd for candesartan cilexetil & hydrochlorothiazide (ATACAND PLUS) tablets 32/12.5 mg & 32/25 mg for the indication:

The treatment of hypertension. Treatment should not be initiated with these fixed dose combinations.

RESOLUTION 9314

ADEC recommends approval of the submission from sanofi aventis Australia Pty Ltd for the new combination clopidogrel and aspirin film-coated tablet (Co-Plavix, Clopidogrel Winthrop plus Aspirin, Plavasa, Plavix Combi, Duo Plavix (all with strengths included)) 75 mg/ 75 mg & 75 mg/100 mg for the indication:

Tradename is a fixed-dose combination product intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products:

  • Unstable angina or non-ST elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Tradename is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent).
  • ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, tradename has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

RESOLUTION 9315

ADEC recommends approval of the submission from BRISTOL-MYERS SQUIBB AUSTRALIA PTY LTD for the new combination clopidogrel and aspirin film-coated tablet (DuoCover, ComCover, Apothecon (all with strengths included)) 75 mg/ 75 mg & 75 mg/100 mg for the indication:

Tradename is a fixed-dose combination product intended as continuation of therapy in patients with acute coronary syndrome already initiated with separate clopidogrel and aspirin products:

  • Unstable angina or non-ST elevation myocardial infarction in order to prevent early and long-term atherothrombotic events (myocardial infarction, stroke, vascular death or refractory ischaemia). Tradename is indicated for the treatment of acute coronary syndrome whether or not patients undergo cardiac revascularisation (surgical or PCI, with or without stent).
  • ST-segment elevation acute myocardial infarction in order to prevent atherothrombotic events. In this population, tradename has been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction or stroke in medically treated patients eligible for thrombolytic therapy.

RESOLUTION 9316

ADEC recommends approval of the submission from Novartis Pharmaceuticals Pty Ltd to increase the maximum dose from 30 mg/kg/day to 40 mg/kg/day for deferasirox (EXJADE) dispersible tablets, 125 mg, 250 mg and 500 mg for the indication:

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

RESOLUTION 9317

ADEC recommends approval of the submission from GlaxoSmithKline Australia Pty Ltd for the new dose form of topotecan (as hydrochloride) (HYCAMTIN) capsules 0.25 mg and 1 mg for the indication:

Treatment of patients with relapsed small cell lung cancer for whom re-treatment with the first-line regimen is not considered appropriate.

RESOLUTION 9319

ADEC recommends approval of the submission from Roche Products Pty Ltd to extend the indications for rituximab (MABTHERA) injection 100 mg / 10 mL & 500 mg / 50 mL to include the indication:

First-line treatment of patients with CD20 positive chronic lymphocytic leukaemia (CLL) in combination with chemotherapy.

RESOLUTION 9320

ADEC recommends approval of the submission from AstraZeneca Pty Ltd to extend the indications for esomeprazole (as magnesium trihydrate) (NEXIUM) granules for oral suspension 10 mg and tablets 20 mg and 40 mg to include the indication:

Prevention of rebleeding of gastric or duodenal ulcers following treatment with NEXIUM solution given intravenously.

RESOLUTION 9321

ADEC recommends approval of the submission from AstraZeneca Pty Ltd to extend the indications for esomeprazole (as sodium) (NEXIUM) powder for injection 40 mg to include:

  • prevention of rebleeding in patients following therapeutic endoscopy for acute, bleeding gastric or duodenal ulcers;
  • Short term management in patients requiring continued nonsteroidal 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.

Nexium IV should be replaced with oral acid suppression therapy as soon as practicable.

RESOLUTION 9322

ADEC recommends approval of the submission from Hospira Pty Limited to extend the indications and increase the recommended dose for dexmedetomidine hydrochloride (PRECEDEX) injection 200 microgram / 2 mL, for the indication:

  1. Sedation of initially intubated patients during treatment in an intensive care setting. The use of PRECEDEX by continuous infusion in these patients should not exceed 24 hours.
  2. Sedation of nonintubated patients prior to and/or during surgical and other procedures.

RESOLUTION 9323

ADEC recommends approval of the submission from CSL Limited for immunoglobulin - anti-D Rho (RHOPHYLAC) solution for injection 1500 IU for the indication:

Prevention of Rh sensitisation in Rh(D)-negative females at or below child-bearing age. Treatment of Rh(D)-negative persons after incompatible transfusions of Rh(D)-positive blood or other products containing red blood cells.

14 August 2009

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