Gazette APVMA 8, 2 August 2005 page 23

NOTICE

Deoxycortone pivalate

[in the product: PERCORTEN-V INJECTION FOR DOGS]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Novartis Animal Health Australasia Pty Ltd, 54 Waterloo Road, North Ryde NSW 2113 for the registration of a new product containing the active constituent deoxycortone pivalate. The product is PERCORTEN-V INJECTION FOR DOGS. The product is for use in dogs.

In accordance with section 13 of the Agvet Code, the APVMA invites any person to submit a relevant written submission as to whether the application for registration should be granted. Submissions should state the grounds on which they are based. Such grounds should relate only to matters outlined below that the APVMA is required to take into account in deciding whether to grant the application. Comments must be received by the APVMA within 28 days of the date of this notice.

Particulars of Application

Proposed product name: PERCORTEN-V INJECTION FOR DOGS
Applicant company: Novartis Animal Health Australasia Pty Ltd.
Name of active constituent: Deoxycortone pivalate
Signal heading: Schedule 4
Statement of claims: Intramuscular injection for replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.
Pack sizes: 1x4mL clear glass vial inside a carton.

Summary of the APVMA’s evaluation of PERCORTEN-V INJECTION FOR DOGS in accordance with Section 14(3)(e) and (f) of the Agricultural and Veterinary Chemicals Code (the ‘Agvet Code’), scheduled to the Agricultural and Veterinary Chemicals Code Act 1994

The APVMA has evaluated the application and in its assessment in relation to human and environmental safety under section 14(3)(e) of the Agvet Code, it proposes to determine that:

(i) The APVMA is satisfied that the proposed use of PERCORTEN-V INJECTION FOR DOGS would not be an undue hazard to the safety of people exposed to it during its handling and use.

The Office of Chemical Safety in the Commonwealth Department of Health and Ageing assessed the human toxicological aspects of this application. The product will be used by injection in individual dogs under veterinary care and any significant toxicity concerns for the user of the product are adequately addressed on the label. The active constituent deoxycortone pivalate is listed in Schedule 4 of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP).

The product will be formulated in the United States of America or the United Kingdom and repackaging will not be required in Australia.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(ii) The APVMA is satisfied that the proposed use of PERCORTEN-V INJECTION FOR DOGS will not be an undue hazard to the safety of people using this product. There are no residues concerns with products used in dogs because dogs are not food producing animals in Australia.

(iii) The APVMA is satisfied that the proposed use of deoxycortone pivalate in PERCORTEN-V INJECTION FOR DOGS is not likely to be harmful to human beings if used according to the product label directions.

A Notice inviting submissions on the APVMA’s proposal to grant approval for the active constituent deoxycortone pivalate is published in this Gazette. Approval of the active constituent is subject to the 28 day public consultation period and will have the approval number APVMA 59198. The product is scheduled as S4. The appropriate Signal Heading is on the label.

The Office of Chemical Safety has advised that establishment of First Aid Instructions or Safety Directions is not necessary because the product willbe used only by registered veterinary surgeons. No Occupational Health and Safety statements are necessary because the use pattern will limit any significant hazards. The establishment of an Acceptable Daily Intake (ADI) or Acute Reference Dose (ARfD) is unnecessary because the active constituent is not likely to enter the human food chain.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(iv) The APVMA is satisfied that the proposed use of PERCORTEN-V INJECTION FOR DOGS is not likely to have an unintended effect that is harmful to animals, plants or the environment.

Data supplied by the applicant supported the safety of PERCORTEN-V INJECTION FOR DOGS for dogs when used as directed according to the label.

The Department of the Environment and Heritage (DEH) did not need to assess this product because it will be used by intramuscular injection in individual animals under veterinary direction.. It is already scheduled and used in humans.

The APVMA accepts the findings and recommendations of its advisers on this criterion.

(v) The APVMA is satisfied that the proposed use of deoxycortone pivalate in PERCORTEN-V INJECTION FOR DOGS would not adversely affect trade between Australia and places outside Australia because the product is used under prescription on dogs. Dogs are not used for human consumption.

In relation to its assessment of efficacy under section 14(3)(f), the APVMA proposes to determine that:

(vi) The APVMA is satisfied the data from trials supporting the efficacy of PERCORTEN-V INJECTION FOR DOGS adequately demonstrate that under Australian conditions this product is effective for the proposed uses.

Written submissions on the APVMA’s proposal to grant the application for registration should be addressed to:

Dr Roger Meischke
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 6272 5859
Fax: (02) 6272 5249
email: roger.meischke@apvma.gov.au