Gazette APVMA 2, 1 February 2005 page 16

NOTICE

Firocoxib

[in the products: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; AND, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS]

The Australian Pesticides and Veterinary Medicines Authority (APVMA) has before it an application from Merial Australia Pty Ltd for the registration of two new products containing the active constituent firocoxib. The products are: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; AND, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS. The products are for use orally in the relief of pain and control of 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 Application

Proposed product names: PREVICOX 227mg HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS

PREVICOX 57mg HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS

Applicant company: Merial Australia Pty Ltd

Name of active constituent: Firocoxib

Signal heading: Schedule 4

Statement of claims: For the relief of pain and control of inflammation associated with osteoarthritis and other musculoskeletal disorders. A soft tissue surgery model demonstrated effective control of post-operative pain.
Pack sizes: 10, 30 and 60 tablets

Withholding period: Not applicable

Summary of the APVMA’s evaluation of: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; and, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL 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: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; and, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL 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 is to be used on individual dogs under veterinary care and any significant toxicity concerns for the user of the products are adequately addressed on the label. The active constituent firocoxib is listed in Schedule 4 of the Standard for the Uniform Scheduling of Drugs (SUSDP).

The product will be formulated in Canada and imported into Australia in finished blister cards or sealed bottles.

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

(ii) The APVMA is satisfied that the proposed use of: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; and, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS will not be an undue hazard to the safety of people using anything containing its residues.

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

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

(iii) The APVMA is satisfied that the proposed use of firocoxib in: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; and, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL 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 firocoxib was published in the Gazette on 2 November 2004. The Commonwealth Department of Health and Aging has assessed the active constituent firocoxib. The products are scheduled as Schedule 4 of the SUSDP. The appropriate Signal Heading is on the label. First Aid instruction (a) and Safety Directions: ‘ Harmful if swallowed. Wash hands after use’ for firocoxib have been recommended by the Commonwealth Department of Health and Ageing and have been included on the label. It was also recommended that the pack sizes be restricted to bottles containing a maximum of 60 tablets, and blister packs. 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: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; and, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS in dogs is not 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.

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 firocoxib in: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; and, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS would not adversely affect 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 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: PREVICOX 227MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL FOR DOGS; and, PREVICOX 57MG HI-SELECT COX-2 FLAVOURED TABLETS: PAIN AND INFLAMMATION CONTROL 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 in writing to:

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

Phone: (02) 6272 3001
Fax: (02) 6272 5249
Email: karina.tyson@apvma.gov.au