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ADEC 232nd meeting resolutions, 5-6 February 2004

Australian Drug Evaluation Committee

5 February 2004

Published in the Commowealth of Australia Gazette, No. GN 8, 25 February 2004

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 232nd (2004/1) meeting of the Australian Drug Evaluation Committee (ADEC) (5-6 February 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.

Somatropin (rbe) - SAIZEN
Powder for Injection - 1.33mg, 3.33mg & 8mg
Serono Australia Pty. Ltd
New Indication: Replacement therapy in adults with pronounced growth hormone deficiency.

Interferon β-1a (rch) - AVONEX
Powder for Injection 60µg
Biogen Australia Pty Ltd
Indication: The prevention of relapse in patients with secondary progressive multiple sclerosis in whom relapse is still a feature of the disease. Avonex (Interferon β-1a (rch) should not be initiated in patients with secondary progressive multiple sclerosis who have not experienced a relapse in the previous 12 months.

Topiramate - TOPAMAX
Tablet 25mg, 50mg, 100mg, 200mg, 300mg, 400mg
Sprinkle and Capsules 15mg, 25mg, 50mg
Janssen-Cilag Pty Ltd
New Indication: The prophylaxis of migraine headache in adults.

Quetiapine fumarate - SEROQUEL
Tablets, film coated 25mg, 150mg, 300mg
AstraZeneca Pty Ltd
New Indication: As monotherapy for the short-term treatment of acute mania associated with Bipolar I Disorder.

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Mesalazine - SALOFALK
Tablet, enteric coated, 500mg
Orphan Australia Pty Ltd
New Dose Form: For the treatment of acute ulcerative colitis of mild to moderate severity, and for the maintenance of remission and/or the long-term treatment of ulcerative colitis.

Papaverine - DBL PAPAVERINE
Solution for Injection, 30mg/mL, 300mg/10 mL, 120mg/10mL.
Faulding (T/A David Bull Laboratories)
New Indication: The treatment of erectile dysfunction.

Rosuvastatin - CRESTOR
Tablets 10mg, 20mg, 40mg
AstraZeneca Pty Ltd
New Chemical Entity: CRESTOR is indicated, at a starting dose of 5mg, as an adjunct to diet when the response to diet and exercise is inadequate for the treatment of:

  1. Hypercholesterolaemia
  2. Heterozygous and homozygous familial hypercholesterolaemia

Specific reference to the treatment of dyslipidaemia is excluded from the indication on the grounds that there are insufficient data to support a mixed dyslipidaemia indication.

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Pravastatin - PRAVACHOL
Tablets 5mg, 10mg, 20mg, 40mg
Bristol-Myers Squibb Pharmaceuticals
New Dosage and Administration: To increase the maximum daily dosage of Pravachol tablets to 80mg daily for the treatment of hypercholesterolaemia.

Etanercept - ENBREL
Powder for Injection 25mg, vial with diluent syringe
Wyeth Australia Pty Ltd
New Indications: For the treatment of:

  • Severe active adult rheumatoid arthritis, to slow progression of disease-associated structural damage in patients at high risk of erosive disease (See Clinical Trials).
  • The signs and symptoms of active ankylosing spondylitis in adults

Alefacept - AMEVIVE
Powder for Injection, 7.5 and 15 mg vials
Biogen Australia Pty Ltd
New Chemical Entity: For the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for phototherapy or systemic therapy. Safety and efficacy beyond two courses have not been demonstrated.

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Aprepitant - EMEND
Capsule, 125mg and 80 mg
Merck Sharp & Dohme (Australia) Pty Ltd
New Chemical Entity: For use in combination with other antiemetic agents for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy, including high dose cisplatin.

Iron Sucrose - VENOFER
Solution for IV Injection / Infusion - 2.7 g in 5 mL
Baxter Healthcare Pty Ltd
New Chemical Entity: Treatment of iron deficiency anaemia in patients undergoing chronic haemodialysis and who are receiving supplementary erythropoietin therapy.

  • In patients in whom oral iron has been proven to be ineffective or associated with intolerable side-effects, and where alternative parenteral iron products are contraindicated.

Fludarabine phosphate - FLUDARA
Powder For Injection, 50 mg per vial
Tablet, 10 mg
Schering Pty Ltd
New Indication: For the treatment of B-cell chronic lymphocytic leukaemia.

Ibandronic acid - BONDRONAT
Injection, concentrated IV infusion 6mg/6mL, Vial
Indication: Treatment of metastatic bone disease in patients with breast cancer.

Budesonide and Eformoterol fumarate - SYMBICORT 400/12 TURBUHALER
Fixed Combination Metered Dose Dry Powder Inhaler (400 µg + 12 µg per actuation).
New Strength: For the regular treatment of asthma where use of a combination product is appropriate in adults 18 years of age and above. This includes patients who are symptomatic on inhaled corticosteroid therapy and patients who are established on regular long acting beta-agonist and inhaled corticosteroid therapy.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee
18 February 2004

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