Notice is given under section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997 (“Act”), of the following application to vary the conditions of a registered trade name product under section 9(2) of the Act:

Trade Name: NEXGARD Chewables

Registration Number: A011040

Active Ingredients and Concentrations:

Each 0.5g chewable contains 11.3mg afoxolaner for dogs 2 – 4kg
Each 1.25g chewable contains 28.3mg afoxolaner for dogs 4.1 – 10kg
Each 3g chewable contains 68.0mg afoxolaner for dogs 10.1 – 25kg
Each 6g chewable contains 136.0mg afoxolaner for dogs 25.1 – 50kg

Formulation Type: Tablet

Existing Use Claims:

NexGard Chewables kills adult fleas and is indicated for the treatment and prevention of flea (Ctenocephalides spp.) infestations and for the control of New Zealand cattle tick (Haemaphysalis longicornis). Effective flea control with NexGard also prevents flea tapeworm (Dipylidium caninum) infestation.

NexGard chewables also treats and controls demodectic mange caused by Demodex spp., sarcoptic mange caused by Sarcoptes scabiei and ear mite (Otodectes cynotis) infestations.

The safe use of Nexgard Chewables in breeding males and females has not been evaluated.

NexGard Chewables is safe for all breeds and in puppies 8 weeks and older. The safe use of NexGard Chewables in breeding males and females has not been evaluated. Afoxolaner is part of the isoxazoline family of chemicals. Adverse reactions to this family of chemicals are rarely observed but may include vomiting, diarrhoea, lack of energy, decreased appetite, itching and very rarely, neurological signs including seizure and tremor. Most adverse reactions are generally short-lived and resolve spontaneously. If you have any concerns, please speak to your veterinarian.

Proposed New Claims (changes in bold):

NEXGARD Chewables kills adult fleas and is indicated for the treatment and prevention of flea (Ctenocephalides spp.) infestations and for the control of New Zealand cattle ticks (Haemaphysalis longicornis) for 5 weeks (35 days). Following administration, fleas are killed within 6–8 hours. Kills fleas before egg production and therefore prevents the risk of household contamination. Can be used as part of a treatment strategy for the control of flea bite hypersensitivity (FBH).

Effective flea control with NEXGARD also prevents flea tapeworm (Dipylidium caninum) infestation. It also treats and controls demodectic mange caused by Demodex spp., sarcoptic mange caused by Sarcoptes scabiei and ear mite (Otodectes cynotis) infestations.

NEXGARD Chewables is safe for all breeds and in puppies 8 weeks and older and weighing 2kg or more. NEXGARD Chewables has also been shown to be safe in dogs with the ABCB1 (formerly known as MDR-1) gene mutation, such as ivermectin-sensitive Collie breeds. NEXGARD Chewables can be used in breeding, pregnant, and lactating females. The safe use of NEXGARD Chewables in breeding males has not been evaluated.

Any person may make a written submission to the director-general concerning this application.

Under sections 16 and 17 of the Act, a written submission:

1. must state in full the reasons for making the submission;
2. may state any decision sought on that application; and
3. must be received by the director-general no later than 30 working days after the date of this notice.

Each submission must state the trade name product(s) to which it relates. Under section 18 of the Act, a copy of every submission will be forwarded to the applicant.

The following address is:

1. where submissions on this application are to be sent;
2. where requests for copies of the public information relating to the application can be sent;
3. where public information relating to the application can be viewed; and
4. the director-general’s address for service:

ACVM Team, Ministry for Primary Industries, Charles Fergusson Building, 38–42 Bowen Street, Pipitea, Wellington 6011. Postal Address: PO Box 2526, Wellington 6140. Email: acvm.consultation@mpi.govt.nz.

MPI encourages submission by email.

The applicant’s address for service is:

Boehringer Ingelheim Animal Health New Zealand Limited, Level 3, 2 Osterley Way, Manukau, Auckland 2104. Postal Address: PO Box 76211, Manukau, Auckland 2241.

Dated at Wellington this 5th day of October 2023.

MAREE ZINZLEY, Manager Approvals, Ministry for Primary Industries (acting under delegated authority).