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ADEC 197th meeting resolutions, 4-5 June 1998

Australian Drug Evaluation Committee

4 June 1998

Published in the Commonwealth of Australia Gazette

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

AUSTRALIAN DRUG EVALUATION COMMITTEE

RECOMMENDATIONS

The 197th (1998/3) Meeting of the Australian Drug Evaluation Committee (ADEC) (4-5 June 1998) resolved to advise the Parliamentary Secretary to the Minister for Health and Family Services, and the Secretary, Department of Health and Family Services, that the following drugs 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.

OMEPRAZOLE, Losec capsules 10 mg, 20 mg and 40 mg
Astra Pharmaceuticals Pty Ltd
Indication: Symptomatic relief of gastro-oesophageal reflux disease.

ADAPALENE, Differin Topical cream 0.1%
Galderma Australia Pty Ltd
Indication: For the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.

TROVAFLOXACIN MESYLATE, Trovan film coated tablets, 100 mg and 200 mg and Alatrofloxacin mesylate, Trovan IV 5mg/mL
Pfizer Pty Limited
Indication: Troval tablets: respiratory tract infections; intra-abdominal infections; pelvic inflammatory disease; urinary tract infection; gonorrhoea; chlamydial cervicitis, gynaecological and pelvic infections; skin and skin structure infections and prophylaxis of surgical procedures.

Trovan IV solution: respiratory tract infections; intra-abdominal infections; gynaecological and pelvic infections; skin and skin structure infections and prophylaxis of surgical procedures.

CLINDAMYCIN PHOSPHATE, Dalacin T topical lotion, 10 mg/mL
Pharmacia & Upjohn Pty Limited
Indication: Treatment of acne vulgaris, particularly forms in which comedones, papules and pustules predominate.

CLINDAMYCIN HCL, ClindaTech topical solution, 10 mg/mL
Dermatech Laboratories
Indication: Topical treatment of acne vulgaris, particularly forms in which comedones, papules and pustules predominate.

ZAFIRLUKAST, Accolate 20 mg and 40 mg tablets
ICI Australia Operations Pty Ltd
Indication: Prophylaxis and treatment of asthma in adults and children 12 years and over.

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INTERFERON BETA-1 ±, Avonex reconstituting solution for injection, 30 µg/vial
CSL Limited
Indication: For the treatment of relapsing forms of multiple sclerosis.

PRAVASTATIN SODIUM, Pravachol 5 mg, 10 mg, 20 mg and 40 mg tablets
Bristol-Myers Squibb Pharmaceuticals Pty Ltd
Indication: In patients with previous myocardial infarction and average (normal) serum cholesterol levels, Pravachol is indicated to reduce the risk of fatal coronary heart disease and non-fatal myocardial infarction.

STAVUDINE, Zerit; powder for reconstituting oral solution, 1 mg/mL, capsules 5 mg, 20 mg, 30 mg, 40 mg
Bristol-Byers Squibb Pharmaceuticals Pty Ltd
Indication: Treatment of HIV infection in adults and paediatric patients, and adult patients with impaired renal function.

RANITIDINE HCL, Zantac (Histamine (H2) receptor antagonist); 75 mg tablets
Glaxo Wellcome Australia Ltd
Indication: Symptomatic relief of heart burn, dyspepsia and hyperacidity, and to reduce these symptoms when taken prior to foods and drinks known to provoke them.

VALSARTAN, Diovan hard gelatin capsules 80 mg and 160 mg
Novartis Pharmaceuticals Australia Pty Limited
Indication: Treatment of mild to moderate hypertension.

RITUXIMAB, Mabthera injection solution 10 mg/mL
Roche Products Pty Limited
Indication: For the treatment of patients with relapsed or refractory low grade or follicular CD-20 positive B-cell non-Hodgkin's lymphoma.

ENALAPRIL MALEATE/DILTIAZEM MALATE, Teczem 5/180 fixed dose combination tablets 5 mg enalapril maleate and 210 mg diltiazem malate (equivalent to 180 mg diltiazem HCL)
Hoechst Marion Roussell Australia Pty Ltd
Indication: For the treatment of mild to moderate hypertension. This fixed does combination agent should not be used to commence antihypertensive therapy.

IMIQUIMOD, Aldara topical cream 50 mg/g
3M Pharmaceuticals Pty Ltd
Indication: For the treatment of external genital and perianal warts/condyloma acuminata in adults.

TACROLIMUS, Prograf capsules 1 mg and 5 mg; concentrated injection solution 5 mg/mL
Janssen-Cilag Pty Ltd
Indication: As an adjunct to liver or kidney transplantation.

IBUPROFEN/PSEUDOEPHEDRINE HCL, Nurofen Cold and Flu, Ibuprofen 200 mg and pseudoephedrine (as HCL) 30 mg tablets
The Boots Company (Australia) Pty Ltd
Indication: For the relief of the symptoms of colds and flu.

SALBUTAMOL SULPHATE, Airomir pressurised metered dose inhalation 100 µg/dose
3M Pharmaceuticals Pty Ltd
Indication: Relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced asthma or in other situations known to induce bronchospasm.

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The ADEC also resolved to advise the Minister and the Secretary concerning the product information for antibiotics:

Resolution No: 7452

In view of current worldwide efforts to limit the use of vancomycin because of increasing development of vancomycin-resistant Enterococci spp and Staphylococci spp, vancomycin is no longer considered the therapy of choice for the treatment of Clostridium difficile-associated colitis. It is therefore recommended that the standard statement which currently appears in Product Information (PI) documents for antibiotics, as follows:

'However, in moderate to severe cases appropriate therapy such as oral antibacterial agents effective against C. difficile (e.g., vancomycin) should be considered'.

Should be amended to read:

'However, in moderate to severe cases, appropriate therapy with a suitable oral antibacterial agent effective against C. difficile should be considered'.

and:

Following safety concerns over possible confusion arising when methotrexate is prescribed. The ADEC has recommended the addition of a boxed warning to the PI of all methotrexate products:

Resolution No 7444

The dosage and administration section of the PI for methotrexate should include a boxed warning:

"Because of its potential to cause severe toxicity, methotrexate therapy requires close supervision with particular caution to distinguish between daily and weekly dosage regimens. Weekly dosage prescriptions should specify a particular day of the week".

The ADEC made the following decision concerning applications for fixed combination products:

Resolution No 7438

Justifications for fixed combinations of drugs should only be submitted to the ADEC if rejection of the combination is proposed by the Delegate. The ADEC reserves the right to recommend against registration of a fixed combination product, on the grounds that the combination is undesirable, at the time it is formally considered by the Committee.

Professor Martin Tattersall
Chairman
Australian Drug Evaluation Committee

23 June 1998

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