Gazette APVMA 9, 6 September 2005 page 19

NOTICE

Deracoxib

[in the products: DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it applications from Novartis Animal Health Australasia Pty Ltd for registration of two new products containing the active constituent deracoxib. The products are DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS; and, DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS. The products are for use orally in the control of pain and inflammation 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 applications 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 Applications

Proposed products’ names:

DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS

DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS

Applicant company: Novartis Animal Health Australasia Pty Ltd
Name of active constituent: Deracoxib
Signal heading: Schedule 4
Statement of claims:

For the control of pain and inflammation associated with osteoarthritis or orthopaedic surgery in dogs.

Pack sizes: 7, 30 and 90 tablets
Withholding period: Not applicable

Summary of the APVMA’s evaluation of DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS 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 applications 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 DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS would not be an undue hazard to the safety of people exposed to them during their handling and use.

The Office of Chemical Safety (OCS) in the Commonwealth Department of Health and Ageing assessed the human toxicological aspects of these applications. The products will be used on individual dogs under veterinary care, will be dispensed by veterinarians and any significant toxicity concerns for the user of the products are adequately addressed on the label. The active constituent deracoxib is listed in Schedule 4 of the Standard for the Uniform Scheduling of Drugs (SUSDP).

The products will be formulated in Canada or Puerto Rico and imported into Australia in sealed bottles with child-resistant lids.

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

(ii) The APVMA is satisfied that the proposed use of DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS would not be an undue hazard to the safety of people using anything containing their residues.

There are no residues concerns as the products are used in dogs only. The active constituent deracoxib is unlikely to enter the human food chain because dogs are not food-producing animals in Australia.

The APVMA is satisfied that the proposed use of DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS would not be 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 deracoxib was published in Commonwealth of Australia Gazette No. APVMA 8, Tuesday, 2 August 2005. Approval of the active constituent is subject to the 28-day public consultation period.

The Commonwealth Department of Health and Ageing has assessed the active constituent deracoxib. The products are scheduled as Schedule 4 of the SUSDP. The appropriate Signal Heading is on the labels. First Aid instruction (a) and Safety Directions: Nil, have been recommended by the Commonwealth Department of Health and Ageing and have been included on the label. The establishment of an Acceptable Daily Intake (ADI) or Acute Reference Dose (ARfD) was considered 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 DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS in dogs would not be likely to have an unintended effect that is harmful to animals, plants or the environment.

Data supplied supported the safety of the products in dogs when used as directed according to the label instructions.

Environmental risks were considered acceptable using protocols agreed to by the Department of the Environment and Heritage (DEH), taking into account the fact that these products are used in individual companion animals under veterinary prescription.

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

(v) The APVMA is satisfied that the proposed use of DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS would not unduly prejudice trade between Australia and places outside Australia as the product is for use in dogs under veterinary prescription only. Dogs are not used for human consumption in Australia nor exported from Australia for such purposes.

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

(i) The APVMA is satisfied the data from trials supporting the efficacy of DERAMAXX 100MG CHEWABLE TABLETS FOR DOGS and DERAMAXX 25MG CHEWABLE TABLETS FOR DOGS adequately demonstrates that under local conditions these products are effective for the proposed uses.

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

Dr Karina Tyson
Veterinary Medicines Program
Australian Pesticides and Veterinary Medicines Authority
PO Box E240
KINGSTON ACT 2604

Phone: (02) 62723001
Fax: (02) 62725249
Email: karina.tyson@apvma.gov.au