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 250th meeting resolutions, 2 February 2007

Australian Drug Evaluation Committee

2 February 2007

Published in the Commonwealth of Australia Gazette, No. GN 8, 28 February 2007

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 250th (2007/1) meeting of the Australian Drug Evaluation Committee (ADEC) (2 February 2007) resolved to advise the Assistant 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 NO 9030

There should be no objection to approval of the submission from Schering-Plough Pty Limited to extend the patient group to include children aged 6-17 years for REMICADE Powder for Injection containing infliximab 100mg for the indication:

the treatment of moderate to severe Crohn's disease to reduce the signs and symptoms and to induce and maintain clinical remission in patients who have an inadequate response to conventional therapies.

RESOLUTION NO 9031

There should be no objection to approval of the submission from CSL Limited to register MODAVIGIL tablets containing modafinil 100mg for the new indications:

  • as an adjunct to continuous positive airways pressure (CPAP) in obstructive sleep apnoea/hypopnoea syndrome in order to improve wakefulness;
  • to treat excessive sleepiness associated with moderate to severe chronic shift work sleep disorder

RESOLUTION NO 9032

There should be no objection to approval of the submission from AstraZeneca Pty Ltd to extend the patient groups for NAROPIN injection containing ropivacaine for the indications:

  • caudal epidural block in neonates (> 37 weeks gestation and over 2500g weight), infants and children up to and including 12 years
  • continuous epidural infusion in infants (> 30 days and over 2500g weight) and children up to and including 12 years

RESOLUTION NO 9035

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register PREZISTA tablets containing the new chemical entity darunavir 300mg for the indication:

Darunavir (with ritonavir 100 mg as pharmacokinetic enhancer) is indicated in combination with other antiretroviral agents for treatment of HIV-1 infection in heavily pretreated adults with evidence of viral replication, who have HIV-1 strains resistant to multiple protease inhibitors.

This indication is based on results of analysis of plasma HIV-RNA levels and CD4 cell counts in two open, controlled studies of 24 weeks duration in clinically advanced, 3-class antiretroviral (NRTI, NNRTI, PI) experienced adults.

In deciding to initiate therapy with darunavir careful consideration should be given to treatment history of the individual patient and patterns of mutations associated with different agents. Genotypic or phenotypic testing should be performed to guide the use of darunavir.

RESOLUTION NO 9036

There should be no objection to approval of the submission from Merck Sharp & Dohme (Australia) Pty Ltd to register INVANZ powder for injection containing ertapenem 1g for the new indication:

treatment of moderate to severe diabetic foot infections, which require parenteral antibiotic therapy and are caused by susceptible bacterial pathogens resistant to all other registered antibiotics, or for patients unable to tolerate other antibiotics.

RESOLUTION NO 9039

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Ltd to register LUCENTIS injection containing the new biological entity ranibizumab (rbe) for the indication:

the treatment of neovascular ("wet") age-related macular degeneration (AMD).

LUCENTIS 0.5 mg or 0.3 mg is recommended to be administered by intravitreal injection once a month.

RESOLUTION NO 9040

  1. There should be no objection to approval of the submission from Roche Products Pty Ltd to register BONVIVA tablets containing ibandronic acid 2.5mg
    • for the new indication:the treatment of postmenopausal osteoporosis. Bonviva 2.5mg increases BMD.
  2. There should be no objection to approval of the submission from Roche Products Pty Ltd to register BONVIVA QUARTERLY INJECTION containing ibandronic acid 3mg/3mL for the indication:
    • the treatment of postmenopausal osteoporosis. Bonviva increases BMD.

RESOLUTION NO 9041

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Limited to register GLIVEC tablets containing imatinib 100mg and 400mg and GLIVEC capsules containing imatinib 50mg and 100mg for the new indication:

as monotherapy, for use in relapsed or refractory disease in the treatment of adult Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ve ALL), and

in combination with chemotherapy, in newly diagnosed disease of adult Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ve ALL)

RESOLUTION NO 9042

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Limited to register GLIVEC tablets containing imatinib 100mg and 400mg and GLIVEC capsules containing imatinib 50mg and 100mg for the new indications:

The treatment of:

  • Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans

And where conventional therapies have failed, the treatment of:

  • Myelodysplastic / myeloproliferative disorders (MDS / MPD) associated with platelet-derived growth factor receptor (PDGFR) gene rearrangements
  • Hypereosinophilic syndrome and / or chronic eosinophilic leukaemia (HES / CEL)
  • Aggressive Systemic Mastocytosis