You are here

TGA Internet site archive

The content on this page and other TGA archive pages is provided to assist research and may contain references to activities or policies that have no current application. See the full archive disclaimer.

ADEC 243rd meeting resolutions, 1-2 December 2005

Australian Drug Evaluation Committee

1 December 2005

Published in the Commonwealth of Australia Gazette, No. GN 6, 15 February 2006

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 243rd (2005/6) meeting of the Australian Drug Evaluation Committee (ADEC) (1-2 December 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. This recommendation for approval may be subject to specific conditions.

VENLAFAXINE 75mg
Efexor-XR
Modified release capsules
Wyeth Australia Pty Limited
Extension of Indication - the treatment of and prevention of relapse of Panic Disorder in adults.

CLINDAMYCIN (as phosphate) 1% AND BENZOYL PEROXIDE 5% GEL
Duac Once Daily
Gel
Stiefel Laboratories
New fixed combination - The treatment of comedo, papular and pustular acne vulgaris.

YTTRIUM [90Y] CHLORIDE 1.85 GBq/mL
Ytracis
Solution for Injection
Schering Pty Ltd
New substance - To be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide. YTRACIS is not intended for direct administration to patients.

MOXIFLOXACIN 400mg
Avelox
Tablet
Bayer Australia Limited
Extension of Indication - the treatment of adults with severe and complicated skin and skin structure infections, who require initial parenteral therapy and who are allergic to alternative agents, especially penicillin allergy, and when caused by organisms known to be susceptible to moxifloxacin.

Top of page

INFLIXIMAB 100 mg
Remicade
Powder for Injection
Schering-Plough Pty Limited
Extension of Indication - The treatment of the signs and symptoms of active psoriatic arthritis in adults where previous response to DMARDS has been inadequate. Infliximab is not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease;

and in relation to RA:

in combination with methotrexate, the reduction of signs and symptoms and prevention of structural joint damage (erosions and joint space narrowing) in:

  • patients with active disease despite treatment with methotrexate.
  • patients with active disease who have not previously received methotrexate.

NICOTINIC ACID 375mg, 500mg, 750mg and 1000mg
Niaspan
Prolonged release tablet
Alphapharm Pty ltd
New dose form - The treatment of mixed dyslipidaemia, and primary hypercholesterolaemia, as adjunctive therapy to diet. Prior to initiating therapy with nicotinic acid, secondary causes of hypercholesterolaemia (e.g. poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinaemias, obstructive liver disease, other drug therapy, alcoholism) should be identified and treated.

HUMAN PLASMA PROTEINS 250IU, 500IU and 1000IU
Octanate
Powder for Injection
Octapharma Australia Pty Ltd
New substance - The treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).

FULVESTRANT 250mg per 5ml
Faslodex
Solution for Injection
AstraZeneca Pty Ltd
New substance - The treatment of post-menopausal women with hormone receptor positive locally advanced or metastatic breast cancer, who have progressive disease following prior tamoxifen therapy.

Top of page

BUDESONIDE/EFORMOTEROL INHALATION 100/6 & 200/6
Symbicort
Pressurised metered dose inhaler
AstraZeneca Pty Ltd
New dose form and Extension of Indication - For the regular treatment of asthma where use of a combination (inhaled corticosteroid and long-acting beta 2-agonist) is appropriate in adults and adolescents 12 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 2-agonist and inhaled corticosteroid therapy.

ANECORTAVE 15mg per 0.5ml
Retaane
Suspension for injection
Alcon Laboratories (Australia) Pty Ltd
New substance - the treatment of subfoveal choroidal neovascularisation (CNV) due to exudative age-related macular degeneration (AMD) where there is a classic component.

BORTEZOMIB 3.5 mg
Velcade
Powder for Injection
Janssen-Cilag Pty ltd
New substance - The treatment of multiple myeloma in patients who have received at least one prior therapy and who have progressive disease.

ERLOTINIB 25mg, 100mg and 150 mg
Tarceva
Tablet
Roche Products Pty Limited
New substance - The treatment of patients with locally advanced or metastatic non-small cell lung cancer who have disease progression following prior chemotherapy.

OMALIZUMAB 75 and 150 mg
Xolair
Powder for Injection
Novartis Pharmaceuticals Australia Pty Ltd
Extension of Indication - The management of adult and adolescent patients with severe allergic asthma, who are already being treated with inhaled corticosteroids and who have raised serum immunoglobulin E levels.

1 February 2006

Top of page