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ADEC 261st meeting resolutions, 4-5 December 2008

Australian Drug Evaluation Committee

4 December 2008

Published in the Commonwealth of Australia Gazette, No. GN 4, 4 February 2009

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 261st (2008/6) meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 December 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 9230

There should be no objection to approval of the submission from Bayer Australia Limited to register MABCAMPATH solution for injection, containing alemtuzumab 30mg/mL for the new indication:

For the treatment of patients with B-cell chronic lymphocytic leukaemia (B-CLL).

RESOLUTION 9231

There should be no objection to approval of the submission from CSL Limited to register a new formulation and new strength of PRIVIGEN solution for injection containing 5 g/50 mL, 10 g/100 mL and 20 g/200 mL of normal immunoglobulin (human) for the indications:

Replacement therapy

  • Primary immunodeficiency (PID) syndromes such as:
    • congenital agammaglobulinaemia and hypogammaglobulinaemia
    • common variable immunodeficiency
    • severe combined immunodeficiency
    • Wiskott Aldrich syndrome
  • Myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections
  • Children with congenital Acquired Immunodeficiency Syndrome (AIDS) and recurrent infections.

Immunomodulatory therapy

  • Idiopathic thrombocytopenic purpura (ITP) in children or adults at high risk of bleeding or prior to surgery to correct the platelet count
  • Guillain-Barre Syndrome (GBS)
  • Kawasaki disease.

Allogenic bone marrow transplantation.

RESOLUTION 9232

There should be no objection to approval of the submission from GlaxoSmithKline Australia Pty Ltd to register a new formulation and manufacturing process of MENCEVAX ACWY containing meningococcal polysaccharide vaccine powder for injection containing 50 µg of each of the purified capsular meningococcal polysaccharide serogroups A, C, W135 and Y for the current indications by subcutaneous injection:

For active immunisation of adults and children over two years against meningococcal meningitis caused by groups A, C, W135 and Y meningococci.

The vaccine may be used for:

  • Individuals who are close contacts of patients with disease caused by meningococci of Groups A,C, W135 and Y.
  • Travellers to countries where the disease is endemic or highly epidemic.
  • Controlling epidemics of infection caused by a group A, C, W135 and Y meningococci in confined communities.
  • Individuals with inherited defects of properdin or complement, or functional or anatomical asplenia.

Mencevax ACWY is not recommended for use in infants and children under two years of age as theantigenicity of the vaccine is low in this age group and antibodies persist for shorter duration.

RESOLUTION 9233

There should be no objection to approval of the submission from Baxter Healthcare Pty Limited to register a new formulation of TISSEEL DUO 500 solution containing fibrinogen (human) 72-110 mg, Factor XIII (human) <10 IU, aprotinin (bovine) 3000 KIU, thrombin (human) 500 IU and calcium chloride 40 µmol in the combined volume of 2 mL fibrin sealant for the current indications:

  • as an adjunct to haemostasis during surgical procedures when control of bleeding by conventional surgical techniques is ineffective or impractical; and
  • as a sealant as an adjunct for closure of colostomies.

RESOLUTION 9234

There should be no objection to approval of the submission from AstraZeneca Pty Ltd to register SEROQUEL film-coated tablet containing quetiapine 25 mg, 100 mg, 150 mg, 200 mg and 300 mg for the new indication:

Treatment of depressive episodes associated with bipolar disorder.

RESOLUTION 9235

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register VELCADE powder for injection containing bortezomib 3.5 mg for the new indication:

VELCADE in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy.

RESOLUTION 9236

There should be no objection to approval of the submission from Sanofi-Aventis Australia Pty Ltd to register TAXOTERE solution for injection containing docetaxel 20 mg and 80 mg for the new indications:

  • Doxorubicin and cyclophosphamide followed by Taxotere in combination with trastuzumab (AC-TH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2.
  • Taxotere in combination with trastuzumab and carboplatin (TCH) is indicated for the adjuvant treatment of patients with operable breast cancer whose tumours overexpress HER2.

RESOLUTION 9238

There should be no objection to approval of the submission from Galderma Australia Pty Ltd to register EPIDUO gel containing the combination of active ingredients of adapalene and benzoyl peroxide 1 mg/g and 25 mg/g for the indication:

Cutaneous treatment of acne vulgaris on the face, chest and back when comedones, papules and pustules are present, and the condition has not responded to first line treatment.

RESOLUTION 9239

There should be no objection to approval of the submission from Chiron Blood Testing Pty Ltd to register AGGRIPAL suspension for injection, containing influenza virus haemagglutinin 15µg of influenza virus haemagglutinin from three strains for the indication:

For the prevention of influenza caused by Influenza Virus, Types A and B.

RESOLUTION 9240

There should be no objection to approval of the submission from Allergan Australia Pty Limited to register GANFORT eye drops containing bimatoprost 0.3 mg/mL (0.03% w/v) and timolol (as the maleate salt) 5.0 mg/mL (0.5% w/v) for the indication:

Reduction of intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension who are insufficiently responsive to monotherapy.

RESOLUTION 9241

There should be no objection to approval of the submission from Nycomed Pty Ltd to register SOMAC enteric-coated granules containing pantoprazole 40 mg granules for the indications:

For symptomatic improvement and healing of the following gastrointestinal diseases which require a reduction in acid secretion.

  • Duodenal ulcer
  • Gastric ulcer
  • Gastroesophageal reflux disease (GORD).
    • Symptomatic GORD. The treatment of heartburn and other symptoms associated with GORD.
    • Reflux oesophagitis.
  • Gastrointestinal lesions refractory to H2-blockers
  • Zollinger-Ellison syndrome.

Patients whose gastric or duodenal ulceration is not associated with ingestion of NSAIDs require treatment with antimicrobial agents in addition to antisecretory drugs whether on first presentation or on recurrence.

Maintenance of healed reflux oesophagitis in patients previously treated for moderate to severe reflux oesophagitis.

For eradication of Helicobacter pylori, treatment with pantoprazole and one of the following combinations of antibiotics: clarithromycin and amoxycillin or clarithromycin and metronidazole or amoxycillin and metronidazole is recommended in cases of duodenal ulcer and gastric ulcer with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism (see Dosage and Administration).

Pantoprazole in combination with bismuth, metronidazole and tetracycline is indicated for the eradication of H. pylori associated with peptic ulcer disease with the objective of reducing the recurrence of peptic ulcers caused by this organism.

Prevention of gastroduodenal lesions and dyspeptic symptoms associated with non-selective non-steroidal anti-inflammatory drugs (NSAIDs) in increased risk patients with a need for continuous non-selective NSAID treatment.

RESOLUTION 9242

There should be no objection to approval of the submission from CSL Limited to register JESPECT suspension for injection containing Japanese encephalitis virus 6 µg purified inactivated JEV strain SA14-14-2 per 0.5 mL dose for the indication:

For active immunisation against Japanese Encephalitis (JE) virus for persons 18 years of age and older.

JESPECT should be considered for use in persons who plan to reside in or travel to areas where JE is endemic (common) or epidemic (seasonal).

JESPECT is indicated for persons who work with JE virus in laboratories and in industry. Safety and efficacy has not been established in persons under 18 years of age. The primary vaccination series consists of 2 IM doses with the second dose administered 28 days after the first dose.

RESOLUTION 9243

There should be no objection to approval of the submission from Generic Health Pty Ltd to register ENALAPRIL BELLWETHER, ENALAPRIL GH, ENALAPRIL BW AND ENALAPRIL GENERIC HEALTH tablets containing enalapril maleate 5 mg, 10 mg & 20 mg for the indication:

Hypertension
All grades of essential hypertension; renovascular hypertension.

Congestive heart failure
Treatment of all degrees of symptomatic heart failure. In such patients it is recommended that enalapril be administered together with a diuretic.

Left ventricular dysfunction
All degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure.

RESOLUTION 9244

There should be no objection to approval of the submission from Eli Lilly Australia Pty Limited to register the new dose form ZYPREXA ADHERA powder for injection (modified release) containing olanzapine (present as a new salt) 210 mg, 300 mg and 405 mg for the new indication:

For maintenance treatment of schizophrenia in adult patients sufficiently stabilised during acute treatment with oral olanzapine.

RESOLUTION 9245

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register CONCERTA modified release tablet containing methylphenidate 18 mg, 27 mg, 36 mg & 54 mg for the new indication:

For the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

RESOLUTION 9246

There should be no objection to approval of the submission from Janssen-Cilag Pty Ltd to register an additional dosing site for RISPERDAL CONSTA powder for injection containing risperidone 25 mg, 37.5 mg & 50 mg for the indication:

RISPERDAL CONSTA is indicated for the treatment of schizophrenia and related psychoses.

RESOLUTION 9247

The ADEC advised that there should be no objection to approval of the submission from PharmaLink Pty Ltd to register PLETAL tablet containing cilostazol 50 mg & 100 mg for the indication:

Pletal is indicated for the symptomatic improvement of intermittent claudication as indicated by increased maximal and pain-free walking distances, in patients who do not have rest pain and who do not have evidence of peripheral tissue necrosis.

16 January 2009