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ADEC 240th meeting resolutions, 2-3 June 2005

Australian Drug Evaluation Committee

2 June 2005

Published in the Commowealth of Australia Gazette, No. GN 25, 29 June 2005

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 240th (2005/3) meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 June 2005) 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.

OXYBUTYNIN HYDROCHLORIDE, 5mg, 10mg and 15mg
Lyrinel XL
Extended release tablet
Janssen-Cilag Pty Ltd
New Dose Form: For the treatment of overactive bladder with symptoms of urinary incontinence, urgency and frequency.

SEVELAMER HYDROCHLORIDE, 400mg and 800mg
Renagel
Tablet
Genzyme Australasia Pty Ltd.
New Chemical Entity: For the management of hyperphosphataemia in adult patients with stage IV or V chronic kidney disease.

AMLODIPINE BESYLATE 5mg and 10mg / ATORVASTATIN CALCIUM 10mg, 20mg, 40mg and 80mg &
Caduet
Tablet
Pfizer Australia Pty Ltd.
New Combination: For treatment of patients in whom treatment with amlodipine and atorvastatin is appropriate at the doses presented.

The indications for amlodipine are:

  1. Hypertension: Amlodipine is indicated for the first line treatment of hypertension and 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 addition to amlodipine which has been used in combination with a thiazide diuretic, beta-adrenoceptor blocking agent or an angiotensin-converting enzyme inhibitor.
  2. Angina: Amlodipine is indicated for the first line treatment of chronic stable angina. Amlodipine may be used alone, as monotherapy or in combination with other anti-anginal drugs.

The indications for atorvastatin are:

  1. Atorvastatin is indicated as an adjunct to diet for the treatment of patients with hypercholesterolaemia.

    Prior to initiating therapy with atorvastatin, secondary causes of hypercholesterolaemia (eg poorly controlled diabetes milletus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, and alcoholism) should be identified and treated.
  2. 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 Clinical Trials) to reduce the risk of non-fatal myocardial infarction and non-fatal stroke.

These effects do not replace the need to independently control known causes of cardiovascular mortality and morbidity such as hypertension, diabetes and smoking.

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FONDAPARINUX SODIUM, 2.5mg/0.5mL
Arixtra
Solution for Injection
GlaxoSmithKline Australia Pty Ltd.
New Indication: For the prevention of venous thromboembolic events (VTE) in patients undergoing abdominal surgery who are at risk of thromboembolic complications.

LEUPRORELIN ACETATE, 45mg
Eligard 6 Month
Suspension for Injection
Mayne Pharma Pty Ltd.
New Strength: Palliative treatment of advanced prostate cancer.

MOMETASONE FUROATE, 50µg per actuation
Nasonex
Nasal Spray
Schering-Plough Pty Limited
New Indication: For the treatment of nasal polyps in adult patients 18 years of age and older.

DORNASE ALFA, 1mg/mL
Pulmozyme
Solution for Inhalation
Roche Products Pty Limited
Change in Patient Group: To include children less than five years of age. The indication should be:

For the management of demonstrated respiratory complications in cystic fibrosis.
Continued use should depend on demonstrating a sustained benefit based on clinical response and, if able to be performed, pulmonary function tests.

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EPOETIN ALFA
Eprex
Solution for Injection
Janssen-Cilag Pty Ltd.
New Route of Administration: For the treatment of anaemia associated with chronic renal failure.

GRANISETRON HYDROCHLORIDE, 200µg/mL, 1mg and 2mg
Kytril
Oral solution and tablet
Roche Products Pty Limited
New Indication: For the prevention of nausea and vomiting induced by radiotherapy.

TAZAROTENE, 0.5mg/g and 1.0mg/g
Zorac
Cream
Allergan Australia Pty Limited
New Dose Form: Treatment of plaque psoriasis.

TAZAROTENE, 1.0mg/g
Zorac
Cream
Allergan Australia Pty Limited
New Dose Form: Treatment of facial acne.

TRAVOPROST 0.004% / TIMOLOL MALEATE 0.5%
Extravan
Eye Drops
Alcon Laboratories (Australia) Pty Ltd.
New Combination: For the reduction of elevated intraocular pressure in patients with open angle glaucoma and ocular hypertension for whom single agent therapy provides insufficient intraocular pressure reduction.

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DICLOFENAC SODIUM, 1mg/mL
Eye Drops
Voltaren Ophtha
Novartis Pharmaceuticals Australia Pty Ltd
New Chemical Entity: For the reduction of post-operative inflammation in cataract surgery and other surgical interventions.

PAROXETINE HYDROCHLORIDE, 12.5mg and 25mg
Tablet
Aropax CR & Paroxat CR
GlaxoSmithKline Australia Pty Ltd
New Indication: For the treatment of Social Anxiety Disorder/Social Phobia and for the treatment of Premenstrual Dysphoric Disorder.

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE, 20mg
Nexium
Film-coated tablets
AstraZeneca Pty Ltd.
New Indication: For the:

  • Healing of gastric ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy.
  • Prevention of gastric ulcers and duodenal ulcers associated with non-steroidal anti-inflammatory drug NSAID (non-selective and COX-2 selective) therapy in patients at risk.

BOTULINUM TOXIN TYPE A PURIFIED NEUTROTOXIN COMPLEX, 100U
Botox
Powder for Injection
Allergan Australia Pty Ltd.
New Indication: For the treatment of spasmodic dysphonia.

BOTULINUM TOXIN TYPE A PURIFIED NEUROTOXIN COMPLEX, 100U
Botox
Powder for Injection
Allergan Australia Pty Ltd.
New Indication: For the treatment of strabismus in children and adults.

INACTIVATED RABIES VIRUS VACCINE, 2.5IU/mL
Rabipur
Powder for Injection
CSL Limited
New Chemical Entity: For the indication:

  • active immunisation against rabies virus for pre-exposure immunisation, and
  • for postexposure treatment following exposure to rabies virus.

CHARCOAL, 120mg/3mL
Charcotrace
Suspension for Injection
Ophthalmic Laboratories Pty Limited
New Indication, New Route of Administration and New Dose Form: For use as an aid in stereotactic or ultrasonic localisation of small impalpable lesions of the breast for later surgical excision

YELLOW FEVER VACCINE (LIVE) ATTENUATED, 0.5mL
Arilvax
Suspension for Injection
CSL Limited
New Chemical Entity: For the indication:

  • active immunisation against yellow fever infection in adults and children aged 9 months and older.

PROPOFOL, 500mg/50mL syringe, 200mg/20mL, 500mg/50mL and 1g/100mL vial
Diprivan
Injection
AstraZeneca Pty Ltd
New Indication: To include:

  • The induction of general anaesthesia in children aged one month and older.
  • The maintenance of general anaesthesia in children from one month to three years of age - for procedures not exceeding 60 minutes, unless alternative anaesthetic agents are not suitable.

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GENERAL RECOMMENDATION TO THE PHARMACEUTICAL INDUSTRY

The 240th (2005/3) meeting of the Australian Drug Evaluation Committee (ADEC) (2-3 June 2005) resolved to advise the Parliamentary Secretary to the Minister for Health and Ageing and the Secretary, Department of Health and Ageing that:

  1. The ADEC notes the importance of the pharmaceutical industry to:
    • adhere to the principles of Good Laboratory Practice and Good Clinical Practice, and
    • adhere to relevant ethical statements, applying in force in various jurisdictions (in line with the Declaration of Helsinki and Australia's National Statement), in order for there to be confidence in the integrity of the data forming part of the submission.
  2. The Committee also notes that compliance with GCP and relevant ethical standards is required by the TGA for all submissions and the Committee supports the role of the TGA in routinely requiring evidence of such compliance and undertaking further inquiries on a case by case basis to ensure data integrity.

20 June 2005

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