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ADEC 258th meeting resolutions, 6 June 2008

Australian Drug Evaluation Committee

6 June 2008

Published in the Commonwealth of Australia Gazette, No. GN 29, 23 July 2008

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 258th (2008/3) meeting of the Australian Drug Evaluation Committee (ADEC) (6 June 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 9182

There should be no objection to approval of the submission from Genzyme Australasia Pty Ltd to register THYMOGLOBULINE Powder for Injection, containing the new biological entity rabbit anti-human thymocyte immunoglobulin 25 mg for the indications:

The prophylaxis of graft rejection in renal transplantation;
Treatment of steroid-resistant or moderate to severe renal transplant rejection;
Treatment of refractory or relapsing aplastic anaemia.

RESOLUTION 9184

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register Product Information changes to include the safety results from the SPARCL study trial in the Precautions section for LIPITOR/XARATOR film-coated tablets containing the atorvastatin (as calcium) 10 mg, 20 mg, 40 mg and 80 mg.

RESOLUTION 9185

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register PI changes to include the safety results from the SPARCL study trial in the Clinical Trials section for CADUET film-coated tablets containing amlodipine (as besylate) and atorvastatin (as calcium) in the following fixed combinations of 5 mg / 10 mg, 5 mg / 20 mg, 5 mg / 40 mg, 5 mg / 80 mg, 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg and 10 mg / 80 mg respectively.

RESOLUTION 9186

There should be no objection to approval of the submission from Orphan Australia Pty Ltd to register a new once daily dosage regimen for SALOFALK modified release granules containing mesalazine 500mg and 1g per sachet, SALOFALK modified release granules containing mesalazine 80g per bottle and SALOFALK enteric coated tablets containing mesalazine 500mg for the following indications:

Granules: 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.
Tablets: For the treatment of acute episodes and maintenance of remission of: mild to moderate ulcerative colitis; and Crohn's ileitis and colitis

There should be no objection to approval of the submission to register the new strength of SALOFALK modified release granules containing mesalazine 1.5g per sachet for the new dosage regimen and current indications.

There should be no objection to approval of the submission to extend the patient population to include children older than 6 years of age for SALOFALK modified release granules and SALOFALK enteric coated tablets for the following indications:

Granules: 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.
Tablets: For the treatment of acute episodes and maintenance of remission of: mild to moderate ulcerative colitis.

RESOLUTION 9187

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register the new dose form JURNISTA modified release tablets containing hydromorphone hydrochloride, 8 mg, 16 mg, 32 mg, and 64 mg for the indication:

For the treatment of moderate to severe chronic pain.

RESOLUTION 9188

There should be no objection to approval of the submission from Wyeth Australia Pty Limited to register PRISTIQ modified release tablets containing the new chemical entity desvenlafaxine (as succinate) 50 mg, 100 mg and 200 mg for the indication:

For the treatment of major depressive disorder (MDD) including prevention of relapse

RESOLUTION 9189

There should be no objection to approval of the submission from Nycomed Pty Ltd to register ALVESCO metered dose inhalation containing ciclesonide 40 µg, 80 µg and 160 µg per actuation for the new indication:

For prophylactic treatment of asthma in children 6 to 11 years of age.

RESOLUTION 9190

There should be no objection to approval of the submission from Abraxis Bioscience Australia Pty Ltd to register ABRAXANE powder for injection containing paclitaxel 100 mg for the indication:

For the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.

RESOLUTION 9191

There should be no objection to approval of the submission from Amgen Australia Pty Ltd to register NPLATE powder for injection containing the new biological entity romiplostim 375 mg and 625 mg for the indication:

For the treatment of thrombocytopaenia in adult patients with chronic immune (idiopathic) thrombocytopaenic purpura (ITP)

  • who are non-splenectomised and have had an inadequate response, or are intolerant, to both corticosteroids and immunoglobulins;
  • who are splenectomised and have had an inadequate response to splenectomy.

RESOLUTION 9192

There should be no objection to approval of the submission from Roche Products Pty Ltd to register AVASTIN concentrated solution for injection containing bevacizumab 25 mg/ mL for the following new indications and new dosage regimens:

AVASTIN in combination with fluoropyrimidine-based chemotherapy, is indicated for the treatment of patients with metastatic colorectal cancer.

AVASTIN in combination with interferon alfa-2a, is indicated for the treatment of patients with advanced or metastatic renal cell cancer.

24 June 2008