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ADEC 254th meeting resolutions, 4-5 October 2007

Australian Drug Evaluation Committee

4 October 2007

Published in the Commonwealth of Australia Gazette, No. GN 44, 7 November 2007

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 254th (2007/5) meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 October 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 9101

There should be no objection to approval of the submission from Pfizer Australia Pty Ltd to register EXUBERA, powder for inhalation containing the new chemical entity insulin human 1mg and 3mg for the indication:

For the treatment of adult patients with type 2 diabetes mellitus who failed therapy with oral antidiabetic agents and who require bolus insulin.

For the treatment of adult patients with type 1 diabetes mellitus in conjunction with long or intermediate acting subcutaneous insulin, for whom the potential benefits of using inhaled insulin outweigh the potential safety concerns.

RESOLUTION 9102

There should be no objection to approval of the submission from Delpharm Consultants Pty Limited to register INOmax medicinal gas containing the new chemical entity nitric oxide 800ppm for the indication:

INOmax, in conjunction with ventilatory support and other appropriate agents, is indicated for the treatment of term and near-term (>34 weeks) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension, in order to improve oxygenation and to reduce the need for extracorporeal membrane oxygenation.

RESOLUTION 9103

There should be no objection to approval of the submission from UCB Pharma to register NEUPRO transdermal drug delivery system containing the new chemical entity rotigotine with nominal release rates of 2mg / 4 mg / 6mg / 8mg / 24hr for the indication:

As monotherapy, or in combination with levodopa, for the treatment of idiopathic Parkinson's disease from early stage to advanced disease.

RESOLUTION 9104

There should be no objection to approval of the submission from Orphan Australia Pty Ltd to register BUSULFEX solution for injection containing busulfan 6mg/mL for the indication:

For use, in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

RESOLUTION 9105

There should be no objection to approval of the submission from Celgene Pty Limited to register REVLIMID capsules containing the new chemical entity lenalidomide 5mg, 10mg, 15mg and 25 mg for the indication:

For the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

RESOLUTION 9106

There should be no objection to approval of the submission from Pierre Fabre Medicament Australia Pty Ltd to register NAVELBINE / VINORELBINE PIERRE FABRE injection solution containing vinorelbine tartrate 10mg/mL for the new indication:

The treatment, in combination with cisplatin, of patients with completely resected non-small cell lung cancer of stage IB or greater.

RESOLUTION 9108

There should be no objection to approval of the submission from CSL Limited to register DAIVOBET 50/500 Ointment containing calcipotriol (as hydrate) 50 µg/g and betamethasone 0.5 mg/g (as dipropionate) to amend the method of use in the treatment of plaque-type psoriasis vulgaris amenable to topical therapy. The use of DAIVOBET 50/500 should be intermittent for up to one year under close medical supervision. Treatment should be limited to four week periods, with calcipotriol used alone (or other non-steroidal topical treatments) for one month between periods of use of DAIVOBET 50/500 as needed.

RESOLUTION 9109

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register JANUVIA tablet containing the new chemical entity sitagliptin (as phosphate monohydrate) 25 mg, 50 mg and 100 mg for the indication:

For the treatment of diabetes mellitus type 2 in persons 18 years of age and older who have failed dietary measures and exercise:

  • as dual combination therapy with metformin or with a sulfonylurea or with a thiazolidinedione where the use of a thiazolidinedione is considered appropriate.

RESOLUTION 9110

There should be no objection to approval of the submission from Octapharma Australia Pty Ltd to register GAMMANORM injection solution containing the new biological entity human normal immunoglobulin 165 mg/mL for the indications:

Replacement therapy in adults and children with primary immunodeficiency syndromes such as:

  • Congenital agammaglobunaemia and hypogammaglobulinaemia
  • Common variable immunodeficiency
  • Severe combined immunodeficiency
  • IgG subclass deficiencies with recurrent infections

Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

RESOLUTION 9112

There should be no objection to approval of the submission from Roche Products Pty Ltd to register HERCEPTIN powder for injection containing trastuzumab 150 mg for the new indication:

For the treatment of patients with HER2 positive localised breast cancer in association with chemotherapy in the subgroup of patients with node-negative disease who had small (<20 mm) primary tumours.

RESOLUTION 9113

There should be no objection to approval of the submission from Schering Pty Limited to register VALETTE tablet containing ethinyloestradiol 30 µg and dienogest 2mg for the indication:

For treatment of mild to moderate acne in women who seek contraception.