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ADEC 264th meeting resolutions, 5 June 2009

Australian Drug Evaluation Committee

5 June 2009

Published in the Commonwealth of Australia Gazette, No. GN 27, 15 July 2009

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 264th (2009/3) meeting of the Australian Drug Evaluation Committee (ADEC)(5 June 2009) 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 9292

There should be no objection to approval of the submission from Sandoz Pty Ltd to register BINOCRIT / EPOETIN ALFA(?) SANDOZ / EPOETIN ALFA(?) HEXAL solution for injection containing the similar biological medicinal product epoetin - suffix to be determined, 1000 IU for the indications:

Treatment of patients with symptomatic or transfusion requiring anaemia associated with chronic renal failure to improve their quality of life by improving energy levels, exercise performance, fatigue and sleep patterns and by reducing the need for blood transfusions.
Treatment of anaemia and reduction of transfusion in patients with nonmyeloid malignancies where anaemia develops as a result of concomitantly administered chemotherapy.
Adult patients with mild to moderate anaemia (haemoglobin > 100 to less than or equal to 130g/ L) for elective surgery with an expected moderate blood loss (two to four units or 900 to 1,800mL) to reduce exposure to allogeneic blood transfusion and to facilitate erythropoietic recovery.
Augment autologous blood collection and to limit the decline in haemoglobin in anaemic adult patients who are scheduled for major elective surgery and who are not expected to predeposit their complete perioperative blood needs.

RESOLUTION 9293

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register STELARA solution for injection containing the new biological entity ustekinumab 45mg / 0.5mL & 90mg / 1mL for the indication:

For the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

RESOLUTION 9294

There should be no objection to approval of the submission from Phebra Pty Ltd to register TOBRA-DAY injection containing tobramycin sulfate 500mg / 5mL for the indication:

TOBRA-DAY is indicated for once daily intravenous use in the treatment of cystic fibrosis patients (>5 years old) with acute pulmonary exacerbations caused by susceptible organisms.

RESOLUTION 9295

There should be no objection to approval of the submission from UCB Pharma (Australia) Pty Ltd to register VIMPAT containing the new chemical entity lacosamide 50 mg, 100 mg, 150 mg and 200 mg oral tablets and intravenous solution 10 mg/ mL for the indications:

VIMPAT (lacosamide) tablets are indicated as add-on therapy, in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older.
VIMPAT (lacosamide) injection for intravenous infusion is indicated as add-on therapy in the treatment of partial seizures with or without secondary generalisation in patients with epilepsy aged 16 years and older when oral administration is temporarily not feasible.

RESOLUTION 9296

There should be no objection to approval of the submission from Celgene Pty Limited to register VIDAZA powder for injection containing the new chemical entity azacitidine 100 mg for the indication:

Azacitidine is indicated for the treatment of patients with:

  1. Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS) according to the International Prognostic Scoring System (IPSS), or
  2. Chronic Myelomonocytic Leukemia (CMMoL (10%-29% marrow blasts without Myeloproliferative Disorder), or
  3. Acute Myeloid Leukemia (AML) with 20-30% blasts and multi-lineage dysplasia, according to World Health Organisation Classification (WHO);

in whom allogenic stem cell transplantation is not indicated.

RESOLUTION 9297

There should be no objection to approval of the submission from Baxter Healthcare Pty Ltd to register ACAM2000 lyophilised powder for injection containing the new biological entity vaccinia virus 1.0-5.0 x 108 PFU/mL for the indication:

For active immunization against smallpox disease for persons determined to be at high risk for smallpox infection in an officially declared outbreak

RESOLUTION 9298

There should be no objection to approval of the submission from Eli Lilly Australia Pty Limited to register CYMBALTA enteric capsules containing duloxetine hydrochloride 30 mg and 60 mg for the new indications:

For the treatment of diabetic peripheral neuropathic pain (DPNP).
For the treatment of generalised anxiety disorder (GAD).

RESOLUTION 9300

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia Pty Ltd to register GLIVEC film coated tablets containing imatinib 100 mg and 400 mg and capsules containing imatinib 100 mg and 400 mg:

  • for the new indication, as adjuvant treatment of adult patients following complete gross resection of KIT (CD117)-positive primary GIST;
  • to allow use of an 800 mg daily dose in patients with CD117 positive unresectable and/or metastatic malignant GIST who demonstrate an insufficient response to therapy at a dose of 400 mg daily.

RESOLUTION 9301

There should be no objection to approval of the submission from CSL Limited to register PANVAX pandemic influenza vaccine suspension for injection vial containing influenza virus haemagglutinin H5N1 (pandemic strain to be determined) 30 microgram per 0.5 mL dose for the new indication:

Use in children aged greater than 6 months for prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with Australian Health Authorities' recommendations, taking into account the recommendation of the World Health Organisation.

RESOLUTION 9302

There should be no objection to approval of the submission from Roche Products Pty Ltd to register MIRCERA solution for injection containing the new biological entity methoxy polyethylene glycol-epoetin beta (various strengths) for the indication:

The treatment of anaemia associated with chronic kidney disease.

RESOLUTION 9303

There should be no objection to approval of the submission from Roche Products Pty Ltd to register KONAKION MM solution for injection containing phytomenadione (mixed micelles solution) 10 mg in 1.0 mL for the new route of administration (oral) and new dosage regimens, for the indication:

Haemorrhage or threatened haemorrhage as a result of severe "hypo-prothrombinaemia" (i.e. deficiency of coagulation factors II, VII, IX and X) due, for instance, to overdosage of anticoagulants of the dicoumarol type, or to other forms of hypovitaminosis K (e.g. obstructive jaundice, liver and intestinal disorders, or prolonged administration of antibiotics, sulphonamides or salicylates).

RESOLUTION 9304

There should be no objection to approval of the submission from Novartis Pharmaceuticals Pty Ltd to register:

  • a new trade name AFINITOR tablets containing everolimus 5 mg & 10 mg;
  • a new indication for AFINITOR tablets containing everolimus 5 mg & 10 mg;
  • the new indication is:

Treatment of patients with advanced renal cell carcinoma after failure of treatment with sorafenib or sunitinib.

RESOLUTION 9305

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to vary the Product Information for MICRONOR uncoated tablet containing norethisterone 350 µg with respect to the recommendations for missing a dose; breakthrough bleeding; dosing after vomiting and overdosing.

RESOLUTION 9306

There should be no objection to approval of the submission from Novartis Pharmaceuticals Australia to register ACLASTA/OSTEOVAN solution for injection containing zoledronic acid 5 mg / 100 mL for the new indications:

To increase bone mineral density in men with osteoporosis;
To increase bone mineral density in patients with osteoporosis associated with long term glucocorticoid use;
To prevent glucocorticoid induced bone mineral density loss.

RESOLUTION 9307

There should be no objection to approval of the submission from Abbott Australasia Pty Ltd to register:

  • a new strength of HUMIRA solution for injection containing adalimumab 20 mg / 0.4mL;
  • a new indication for HUMIRA solution for injection containing adalimumab 20mg / 0.4mL and 40mg / 0.8mL;
  • The new indication is:

Polyarticular juvenile idiopathic arthritis: Humira, in combination with methotrexate, is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients aged 4 years of age and older. Humira can be given as monotherapy in case of intolerance or when continued treatment with methotrexate is inappropriate.

12 June 2009

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