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ADEC 251st meeting resolutions, 30 March 2007

Australian Drug Evaluation Committee

30 March 2007

Published in the Commonwealth of Australia Gazette, No. GN 15, 18 April 2007

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 251st (2007/2) meeting of the Australian Drug Evaluation Committee (ADEC) (30 March 2007) 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 NO 9049

There should be no objection to approval of the submission from Eli Lilly Australia Pty Limited to register BYETTA solution for injection containing the new biological entity exenatide 250 µg/mL for the indication:

as adjunctive therapy to improve glycaemic control in patients with type 2 diabetes mellitus who are taking metformin, a sulfonylurea, or a combination of metformin and a sulfonylurea but are not achieving adequate glycaemic control

RESOLUTION NO 9050

There should be no objection to approval of the submission from Roche Products Pty Limited to register a new maintenance dosage regimen for patients who have responded to induction treatment for MABTHERA injection solution containing rituximab 10mg/mL for the following indications:

  • CD20 positive, previously untreated, stage III/IV follicular, B-cell non-Hodgkin's Lymphoma, and
  • CD20 positive, relapsed or refractory low grade or follicular B-cell non-Hodgkin's lymphoma

The approved dosage regimen for both indications should be 375 mg/m2 administered as an intravenous infusion once every three months until disease progression or for a maximum of two years.

RESOLUTION NO 9051

There should be no objection to approval of the submission from Ranbaxy Australia Pty Limited to register GABARAN tablets containing gabapentin 600 mg and 800mg for the indications:

For the maintenance treatment of:

  • partial seizures, including secondary generalised tonic-clonic seizures, initially as add-on therapy in adults and children aged 3 years and above who have not achieved adequate control with standard epileptic drug treatment
  • neuropathic pain.

RESOLUTION NO 9052

There should be no objection to approval of the submission from Eisai Australia Pty Ltd to register ZONEGRAN capsules containing the new chemical entity zonisamide 25 mg, 50 mg, 100 mg for the indication:

Adjunctive therapy in the treatment of adult patients with partial seizures, with or without secondary generalisation.

RESOLUTION NO 9053

There should be no objection to approval of the submission from Sanofi-Synthelabo Australia Pty Limited register PLAVIX film coated tablets containing clopidogrel hydrogen sulfate 75mg for the new indications:

Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

Acute Coronary Syndrome
PLAVIX is indicated in combination with aspirin for patients with:

  • 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). PLAVIX 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, PLAVIX 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 NO 9054

There should be no objection to approval of the submission from Bristol-Myers Squibb Australia Pty Ltd register ISCOVER film coated tablets containing clopidogrel hydrogen sulfate 75mg for the new indications:

Prevention of vascular ischaemia associated with atherothrombotic events (myocardial infarction, stroke and vascular death) in patients with a history of symptomatic atherosclerotic disease.

Acute Coronary Syndrome
ISCOVER is indicated in combination with aspirin for patients with:

  • 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). ISCOVER 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, ISCOVER 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 NO 9055

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register FLOLAN powder for injection containing epoprostenol sodium 0.5mg and 1.5mg for the new indication:

the long-term treatment, via continuous intravenous infusion, in New York Heart Association functional class III or class IV patients with:

  • idiopathic pulmonary arterial hypertension
  • familial pulmonary arterial hypertension
  • pulmonary arterial hypertension associated with the scleroderma spectrum of diseases (SSD)

RESOLUTION NO 9056

There should be no objection to approval of the submission from Mayne Pharma Limited to register the new dose form OXYTROL transdermal drug delivery system containing oxybutynin 36mg for the indication:

treatment of overactive bladder with symptoms of urinary frequency, urgency or incontinence or any combination of these symptoms

RESOLUTION NO 9057

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Limited to register VOLTFAST, powder for oral liquid containing diclofenac potassium 50mg, for the indications:

In adults and adolescents, as short-term treatment (up to one week) for the relief of acute pain states in which there is an inflammatory component; treatment of acute migraine attacks (with or without aura); symptomatic treatment of primary dysmenorrhoea

RESOLUTION NO 9058

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register CERVARIX suspension for injection containing Human Papillomavirus Vaccine Types 16 and 18 (recombinant, AS04 adjuvanted) which contains 20 µg each of HPV-16 L1 and HPV-18 L1 proteins in each 0.5 mL dose for the indication:

CERVARIX is indicated in females from 10 to 45 years of age for the prevention of cervical cancer by protecting against incident and persistent infections, cytological abnormalities including atypical squamous cells of uncertain significance (ASC-US) and cervical intraepithelial neoplasia (CIN), CIN 1 and precancerous lesions (CIN 2 and CIN 3) caused by human papillomavirus types 16 and 18. Immunogenicity studies have been conducted in females aged 10 to 14 years and 26 to 45 years to link efficacy in females aged 15 to 25 years to other populations.

11 April 2007