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ADEC 260th meeting resolutions, 3 October 2008

Australian Drug Evaluation Committee

3 October 2008

Published in the Commonwealth of Australia Gazette, No. GN 45, 12 November 2008

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 260th (2008/5) meeting of the Australian Drug Evaluation Committee (ADEC) (3rd October 2008) 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 9214

There should be no objection to approval of the submission from Wyeth Australia Pty Limited to register RELISTOR solution for injection containing the new chemical entity methylnaltrexone bromide 12 mg / 0.6mL for the indication:

The treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care when response to laxative therapy has not been sufficient.

RESOLUTION 9215

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register VOLIBRIS film-coated tablet containing the new chemical entity ambrisentan 5 and 10 mg for the indication:

The treatment of:

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

RESOLUTION 9216

There should be no objection to approval of the submission from AstraZeneca Pty Ltd to register SEROQUEL film-coated tablet containing quetiapine 25 mg, 100 mg, 150 mg, 200 mg, and 300 mg for the new indications:

  • Maintenance treatment of bipolar 1disorder, in combination with lithium or sodium valproate, for the prevention of recurrence of manic, depressive or mixed episodes.
  • Treatment of acute mania associated with bipolar 1 disorder alone or in combination with lithium or sodium valproate.

RESOLUTION 9217

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register INTELENCE tablet containing the new chemical entity etravirine 100 mg for the indication:

Treatment of HIV-1 infection, in combination with other antiretroviral agents, in antiretroviral treatment-experienced adults who have evidence of viral replication and resistance to Non-nucleoside Reverse Transcriptse Inhibitors and other antiretroviral agents.

This indication is based on 24 week analyses from 2 randomised, double-blind, placebo controlled trials of etravirine. Both studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, N[T]RTI, PI) treatment-experienced adults (see Clinical Trials Section).

Treatment history of patients and genotypic testing should be performed to guide the use of etravirine.

RESOLUTION 9218

There should be no objection to approval of the submission from Sanofi-Aventis Australia Pty Ltd to register a new ampoule presentation and a new route of administration for CLEXANE / LOVENOX injection solution containing enoxaparin sodium 40 mg/0.4mL for the new indication:

Treatment of acute ST-segment elevation myocardial infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be managed medically or with subsequent percutaneous coronary intervention (PCI).

RESOLUTION 9219

There should be no objection to approval of the submission from CSL Limited to register ANGIOMAX powder for injection containing bivalirudin 100 mg and 250 mg for the indication:

For use as an anticoagulant:

  • in the treatment of patients with moderate to high risk acute coronary syndromes (ACS) [unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI)] who are undergoing early invasive management), and
  • in patients undergoing percutaneous coronary intervention (PCI).

Angiomax is intended for use with aspirin and clopidogrel.

RESOLUTION 9220

There should be no objection to approval of the submission from Bayer Australia Limited to register XARELTO film-coated tablet containing the new chemical entity rivaroxaban 10 mg for the indication:

Short term prevention of venous thrombosis in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement).

RESOLUTION 9221

There should be no objection to approval of the submission from Eli Lilly Australia Pty Limited to register EVISTA film-coated tablet containing the raloxifene hydrochloride 60 mg for the new indications:

  • The reduction in risk of invasive breast cancer in post-menopausal women with osteoporosis.
  • The reduction in risk of invasive breast cancer in post-menopausal women at high risk for breast cancer.

RESOLUTION 9222

There should be no objection to approval of the submission made originally by Organon (Australia) Pty Ltd to register BRIDION injection solution containing the new chemical entity sugammadex 100 mg/mL for the indication:

Reversal of neuromuscular blockade induced by rocuronium or vecuronium.

RESOLUTION 9223

There should be no objection to approval of the submission from Novartis Pharmaceuticals Pty Ltd to register CUBICIN powder for injection containing the new biological entity daptomycin 350 mg & 500 mg for the indication:

Treatment of adults with Complicated Skin and Skin Structure infections, who require initial parenteral therapy, and who have intolerance to alternative agents (especially penicillin allergy), and when caused by organisms known to be susceptible to daptomycin.

Daptomycin is also indicated in adults for Staphylococcus aureus bloodstream infections (bacteremia), including right-sided native valve infective endocarditis, 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, left-sided endocarditis should be excluded before using daptomycin.

Daptomycin 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.

RESOLUTION 9224

There should be no objection to approval of the submission from Boehringer Ingelheim Pty Ltd to register PRADAXA capsule containing the new chemical entity dabigatran etexilate 75 mg and 110 mg for the indication:

Short term prevention of venous thrombosis in adult patients who have undergone major orthopaedic surgery of the lower limb (elective total hip or knee replacement).

14 October 2008