ACPM 268th meeting recommendations, 4-5 February 2010

The resolutions for approval of medicines by the ACPM are recommendations for further action by the TGA and do not constitute approvals in their own right.

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ACPM 268th meeting recommendations

Published in the Commonwealth of Australia Gazette, No. GN 9, 10 March 2010

GAZETTAL NOTICE

THERAPEUTIC GOODS ACT 1989

ADVISORY COMMITTEE ON PRESCRIPTION MEDICINES

RECOMMENDATIONS

The 268th (2010/1) meeting of the Advisory Committee on Prescription Medicines (4-5th February 2010) 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 9375

ACPM recommends approval of the submission from Orphan Australia Pty Ltd to change the dosage regimen for ursodeoxycholic acid (URSOFALK / URSO) capsule and oral liquid 250 mg & 250 mg /5 mL. For Primary Biliary Cirrhosis (PBC) the dose regimen to be amended from 10 - 15 mg/kg/day given in 2 - 4 divided doses to:

12-16 mg/kg/day given either as a single daily dose or in 2 - 3 divided doses.

For Cystic Fibrosis (CF)-related cholestasis the dose regimen to be amended from 20 30 mg/kg/day in 2 - 4 divided doses to:

20 mg/kg/day in 2 - 3 divided doses with improvement in liver function the dose may be taken as a single daily dose in the evening

RESOLUTION 9376

ACPM recommends approval of the submission from Boehringer Ingelheim Pty Ltd to register pramipexole hydrochloride (SIFROL ER) extended release tablets 0.375 mg, 0.75 mg, 1.5 mg, 3 mg & 4.5 mg for the indication:

Treatment of signs and symptoms of idiopathic Parkinson's disease. It may be used as monotherapy or in combination with levodopa

RESOLUTION 9377

ACPM recommends approval of the submission from Pharmatel Fresenius Kabi Pty Ltd to register the new parenteral nutrition product containing soya oil, medium chain triglycerides, olive oil and fish Oil (SMOFLIPID 20 %) solution for injection which includes two active ingredients that are not currently registered for parenteral administration (medium chain triglycerides and fish oil) for the indication:

Supply of energy and essential fatty acids to patients, as part of a parenteral nutrition regimen, when oral or enteral nutrition is impossible, insufficient or contraindicated

RESOLUTION 9378

ACPM recommends approval of the submission from Mundipharma Pty Ltd to register the new fixed-dose combination of oxycodone hydrochloride and naloxone hydrochloride (TARGIN) controlled release tablets 5mg /2.5 mg, 10 mg/ 5 mg, 20 mg/10 mg & 40 mg/ 20 mg for the indication:

Management of moderate to severe chronic pain unresponsive to non-narcotic analgesia. The naloxone component in a fixed combination with oxycodone is indicated for the therapy and/ or prophylaxis of opioid-induced constipation.

RESOLUTION 9379

ACPM recommends approval of the submission from Roche Product Pty Ltd to register a new dose form of valganciclovir (as hydrochloride) (VALCYTE) powder for oral solution 50 mg/ mL and to include dosage recommendations in paediatric solid organ transplantation

RESOLUTION 9380

ACPM recommends approval of the submission from Wyeth Australia Pty Limited to register a new-fixed combination for pneumococcal polysaccharide conjugate vaccine, 13 valent, adsorbed (PREVENAR 13) injection 0.5 mL containing 2.2 mcg of pneumococcal capsular saccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F & 23 and 4.4 µg of pneumococcal capsular saccharide for serotype 6B for the indication:

RESOLUTION 9381

ACPM recommends approval of the submission from Janssen-Cilag Pty Ltd to register a new dose form of tacrolimus (PROGRAF-XL) capsules 0.5 mg, 1 mg & 5 mg for the indication:

Adjunct to liver, kidney, heart or lung allograft transplantation in adults and children

RESOLUTION 9382

ACPM recommends approval of the submission from Kendle R and D Pty Limited to register the new chemical entity clevidipine butyrate (CLEVIPREX) solution for injection 25 mg in 50 mL & 50 mg in 100 mL for the indication:

CLEVIPREX is indicated for the short term treatment of hypertension when oral therapy is not feasible or desirable

RESOLUTION 9383

ACPM recommends approval of the submission from Janssen-Cilag Pty Ltd to register the new chemical entity dapoxetine hydrochloride (PRILIGY) tablets 30 mg for indication:

RESOLUTION 9384

ACPM recommends approval of the submission from Baxter Healthcare Pty Ltd to extend the indication for fibrin sealant (TISSEEL DUO 500, TISSEEL VH S/D) two component solution 2 mL, 4 mL & 10 mL to include the indication:

TISSEEL is indicated as a sealant and/or adhesive for use in autologous chondrocyte implantation (ACI) or matrix-induced autologous chondrocyte implantation (MACI) procedures

RESOLUTION 9385

ACPM recommends approval of the submission from Wyeth Australia Pty Limited for the removal of the text "Safety and efficacy beyond 12 months have not been demonstrated" from the current psoriasis indication for etanercept (rch) (ENBREL) powder and solution for injection 25 mg & 50 mg.

RESOLUTION 9386

ACPM recommends approval of the submission from Ferring Pharmaceuticals Pty Ltd to register a new chemical entity degarelix (FIRMAGON) powder and solvent for injection, depot 120 mg & 80 mg for the indication:

Treatment of patients with prostate cancer in whom androgen deprivation therapy is warranted.

RESOLUTION 9387

ACPM recommends approval of the submission from Phebra Pty Ltd to register a new chemical entity caffeine citrate (CAFNEA INJECTION / CAFNEA ORAL SOLUTION) solution for injection 40 mg /mL and oral solution 25 mg /5 mL for the indication:

For the short term treatment of apnoea of prematurity (AOP) in infants between 28 and 33 weeks gestational age

RESOLUTION 9388

ACPM recommends approval of the submission from Amgen Australia Pty Ltd to register a new biological entity denosumab (PROLIA) solution for injection 60 mg /mL for the indication:

The treatment of osteoporosis in postmenopausal women. PROLIA significantly reduces the risk of vertebral, non-vertebral and hip fractures.

RESOLUTION 9389

ACPM recommends approval of the submission from Astrazeneca for an extension of indications for ropivacaine (NAROPIN 0.2%) injection 400 mg/ 200 mL & 200 mg/ 100 ml to include the indication:

Continuous wound infusion for postoperative pain management (adults only).

RESOLUTION 9390

ACPM recommends approval of the submission from Pfizer Australia Pty Ltd for an extension of indications for dalteparin (FRAGMIN) solution for injection 2 500 IU, 5 000 IU, 7 500 IU, 10 000 IU, 12 500 IU, 15 000 IU & 18 000 IU to include the indication:

Extended treatment of symptomatic venous thromboembolism (VTE) to reduce the recurrence of VTE in patients with solid tumour cancers

RESOLUTION 9391

ACPM recommends approval of the submission from Shire Australia Pty Limited to register a new drug substance manufacturing process for algalsidae alfa ghu (REPLAGAL) solution for injection 3.5 mg /3.5 mL

RESOLUTION 9392

ACPM recommends approval of the submission from Novartis Pharmaceuticals Australia Pty Limited to register the new-fixed dose combination of amlodipine besylate, valsartan and hydrochlorothiazide (EXFORGE HCT / EJOCIA HCT) tablets 5 mg/ 160 mg/ 12.5 mg, 5 mg /160 mg/ 25 mg, 10 mg/ 160 mg/ 25 mg & 10 mg/ 320 mg/ 25 mg for the indication:

TRADENAME is indicated ONLY as substitution therapy for the treatment of hypertension in patients whose blood pressure is already adequately controlled on the triple combination of amlodipine, valsartan and hydrochlorothiazide taken either as three single-component formulations or as a dual-component formulation with a single-component formulation, all components at the same dose level. Treatment should not be initiated with this combination. (see DOSAGE AND ADMINISTRATION)

Advisory Committee on Prescription Medicines

1st March 2010

Note

The Advisory Committee on Prescription Medicines replaced the Australian Drug Evaluation Committee under amendments to the Therapeutic Goods Regulations 1990 that were made by the Therapeutic Goods Amendment Regulations 2009 (No. 6) that commenced on 1 January 2010. The effect of transitional provisions in regulation 4 of the amending regulations is that:

• members of old committee continue to be members of the new committee;
• requests to the old committee that had not been finalised are taken to be requests to the new committee; and
• recommendations, assessments or evaluations of an old committee or subcommittee of an old committee must be taken into account if the recommendations, assessments or evaluations had not been formally given to the Minister or Secretary.

Ratified resolutions of the 268th meeting of the Advisory Committee On Prescription Medicines (ACPM) 4-5 February 2010

RESOLUTION 9396

1. The ACPM noted Recommendation No 2097 of the PSC, reiterating its previous Recommendation, No. 2074, regarding the proliferation in the use of multiple trade names which states:
   • The PSC expressed its ongoing concern at the apparent proliferation in multiple trade names for products which in all other respects are indistinguishable (i.e. same sponsor, same active ingredient(s), same dose form(s) and same strength(s)). The Committee considered this practice raises serious Quality Use of Medicine issues, including increasing the potential for prescriber and patient confusion. The PSC requested this matter be brought to the attention of the National Medicines Policy Committee
2. The ACPM endorses the Recommendation made by the PSC and agrees that it should be brought to the attention of National Medicines Policy Committee. In addition to recommending relevant Offices of the TGA as well as external stakeholders should work together to formulate a policy to help address this extremely concerning practice.

RESOLUTION 9397

1. The ACPM noted Recommendation No 2098 of the PSC in relation to encouraging both the innovator and sponsors of generic products to regularly update the Product Information (PI) to take into account emerging and evolving issues that were unavailable and/or impossible to assess at the time the products were first registered
2. The ACPM endorses the Recommendation made by the PSC.