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 263rd meeting resolutions, 2-3 April 2009

Australian Drug Evaluation Committee

2 April 2009

Published in the Commonwealth of Australia Gazette, No. GN 20, 27 May 2009

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 263rd (2009/2) meeting of the Australian Drug Evaluation Committee (ADEC)(2-3 April 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 9270

There should be no objection to approval of the submission from Wyeth Australia Pty Limited to register:

  • the new trade name XYNTHA powder for injection containing moroctocog alfa 250 IU, 500 IU, 1000 IU and 2000 IU, and
  • the new manufacturing process which includes changes to remove all human and animal derived proteins and to introduce a viral nanofiltration step, and
  • the change to the method of measuring the amount of FVIII during the manufacturing process (FVIII potency assignment).

The approved indication for XYNTHA is:

for the control and prevention of haemorrhagic episodes in patients with haemophilia A, including control and prevention of bleeding in surgical settings. XYNTHA does not contain von Willebrand factor and should not be used by patients with von Willebrand disease.

RESOLUTION 9275

There should be no objection to approval of the submission from Novartis Pharmaceuticals Pty Ltd to register Product Information changes to SANDOSTATIN injection containing octreotide 50 µg/mL, 100 µg/mL and 500 µg/mL and SANDOSTATIN LAR injection containing octreotide 10 µg/mL, 20 µg/mL and 30 µg/mL.

It is recommended that the statement that SANDOSTATIN (or SANDOSTATIN LAR) "is not an antitumour therapy" be removed from the indication.

The new indications are:

For SANDOSTATIN.

For symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment. Sandostatin treatment is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.

For the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system:

  • carcinoid tumours with features of the carcinoid syndrome
  • vasoactive intestinal peptide secreting tumours (VIPomas).

Sandostatin is not curative in these patients.

For reduction of the incidence of complications following pancreatic surgery.

For SANDOSTATIN LAR.

For the symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment but who are adequately controlled on s.c. treatment with Sandostatin. Sandostatin LAR is also indicated in acromegalic patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective.

For the relief of symptoms associated with the following functional tumours of the gastro-entero-pancreatic endocrine system:

  • Carcinoid tumours with features of the carcinoid syndrome; and
  • Vasoactive intestinal peptide secreting tumours (VIPomas) in patients who are adequately controlled on subcutaneous treatment with Sandostatin.

Sandostatin LAR is not curative in these patients.

Top of page

RESOLUTION 9276

There should be no objection to approval of the submission from Bayer Australia Ltd to register the new fixed combination product QLAIRA film-coated tablet containing estradiol valerate and dienogest in the following ratios:

  • 2 dark yellow tablets containing 3 mg of oestradiol valerate
  • 5 medium red tablets containing 2 mg of oestradiol valerate and 2 mg of dienogest
  • 17 light yellow tablets containing 2 mg of oestradiol valerate and 3 mg of dienogest
  • 2 dark red tablets containing 1 mg of oestradiol valerate
  • 2 white placebo tablets

for the indication:

oral contraception.

RESOLUTION 9277

There should be no objection to approval of the submission from Alphapharm Pty Ltd to register the new generic ENLAFAX-XR modified release capsules containing venlafaxine 75 mg and 150 mg for the indications:

  • Major Depression, including prevention of relapse and recurrence where appropriate
  • Social Anxiety Disorder

RESOLUTION 9278

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

maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate.

There should be no objection to approval of the application to register SEROQUEL XR modified release tablets containing the quetiapine 50 mg, 200 mg, 300 mg and 400 mg for the following indications.

Bipolar disorder including

  • maintenance treatment of bipolar I disorder, as monotherapy or in combination with lithium or sodium valproate, for the prevention of recurrence of manic, depressive or mixed episodes
  • treatment of depressive episodes associated with bipolar disorder
  • treatment of acute mania associated with bipolar I disorder as monotherapy or in combination with lithium or sodium valproate

RESOLUTION 9279

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

  • a new strength of SEROQUEL XR containing quetiapine 150 mg; and
  • a new indication for SEROQUEL XR modified release tablets containing quetiapine 50 mg, 150 mg, 200 mg and 300 mg.

The new indication is:

as monotherapy, for the treatment of recurrent major depressive disorder (MDD) including the prevention of relapse.

RESOLUTION 9280

There should be no objection to approval of the submission from Sandoz Pty Ltd to register DOXYHEXAL tablets containing doxycycline 50 mg and 100 mg for the new indication:

treatment of anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis.

Top of page

RESOLUTION 9281

There should be no objection to approval of the submission from Roche Products Pty Ltd to register ACTEMRA injection containing the new biological entity tocilizumab (rch) 20 mg/mL for the indication:

for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients:

  • in combination with methotrexate or non-biological disease-modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs; or
  • as monotherapy in case of intolerance to methotrexate (MTX) or where continued treatment with MTX is inappropriate.

RESOLUTION 9282

There should be no objection to approval of the submission from Eli Lilly Australia Pty Ltd to register EFFIENT film coated tablets containing the new chemical entity prasugrel 5 mg and 10 mg for the indication:

Prasugrel, co-administered with aspirin, is indicated for the reduction of recurrent myocardial infarction in patients with acute coronary syndrome (moderate to high risk unstable angina, non ST-segment elevation myocardial infarction or ST-segment elevation myocardial infarction) who are to undergo percutaneous coronary intervention.

RESOLUTION 9283

There should be no objection to approval of the submission from Sigma Pharmaceuticals Australia Pty Ltd to register the new dose form CLINDESSE vaginal cream (2% w/w) containing clindamycin 20 mg/g for the indication:

for single dose local treatment of symptomatic bacterial vaginosis.

Note: For the purpose of this indication, a clinical diagnosis of bacterial vaginosis is usually defined by the presence of off-white (milky or grey) thin, homogeneous vaginal discharge that shows positive results to at least three of the following four criteria: (a) pH > 4.5; (b) an amine ('fishy') odour when mixed with potassium hydroxide 10%; (c) clue cells on microscopy; and (d) Gram stain consistent with a diagnosis of bacterial vaginosis including markedly reduced or absent Lactobacillus morphotype, predominance of Gardnerella morphotype, present or absent Mobiluncus morphotype, and absent or few white blood cells. Other pathogens that may be associated with genital infection such as Trichomonas vaginalis, Candida albicans, Chlamydia trachomatis and Neisseria gonorrhoeae should be ruled out by appropriate laboratory means

RESOLUTION 9284

There should be no objection to approval of the submission from Actelion Pharmaceuticals Australia Pty Limited to register TRACLEER film coated tablets containing bosentan 62.5 mg and 125 mg for the new indication:

for the treatment of:

  • idiopathic pulmonary arterial hypertension
  • familial pulmonary arterial hypertension
  • pulmonary arterial hypertension associated with scleroderma
  • pulmonary arterial hypertension associated with congenital systemic to pulmonary shunts including Eisenmenger's physiology

in patients with WHO functional class II, III or IV symptoms.

RESOLUTION 9285

There should be no objection to approval of the submission from CSL Limited to register NEBILET / LOBIVON tablets containing the new chemical entity nebivolol 1.25 mg, 5 mg and 10 mg for the indication:

  • for the treatment of essential hypertension
  • treatment of stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older

RESOLUTION 9286

There should be no objection to approval of the submission from Eli Lilly Australia Pty Ltd to register FORTEO solution for injection containing teriparatide 250 µg/mL for the new indication:

For the treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at high risk for fracture.

14 April 2009