Notice of Amendment: Correction to the Moxidectin Veterinary Listing on the Prescription Drug List (PDL)

May 31, 2023
Our file number: 23‑104898-891

The purpose of this Notice of Amendment is to announce that Health Canada has amended the qualifier for the moxidectin listing on the veterinary part of the Prescription Drug List (PDL). The human part of the PDL is not affected.

Background

Moxidectin is a broad-spectrum anti-parasitic medicine widely used to treat and prevent parasitic infections in both food-producing and companion animals. Moxidectin was added to the “including (but not limited to)” column of the “Milbemycin or its derivatives” listing on the PDL (Schedule F at the time) in early 2000. When moxidectin was originally marketed for veterinary use, it was for a drug product that was indicated only for prevention of heartworm disease in dogs.

Rationale

Health Canada has amended the PDL veterinary listing of moxidectin to correct an administrative oversight as the previous qualifier “when sold for the treatment of heartworm in dogs” did not capture the veterinary products containing moxidectin that have been authorized as prescription drugs.

A review of the safety and efficacy evidence that is available to Health Canada determined that, moxidectin for different uses in dogs and in additional species (cats and ferrets) continues to warrant prescription status as per the criteria set out in C.01.040.3 of the Food and Drug Regulations.

Health Canada did not undertake a public consultation for this amendment, as there should be no impact on marketed veterinary products containing moxidectin and the Department remains internationally aligned with most regulators. Marketed veterinary products containing moxidectin for dogs, cats and ferrets will continue to be sold as prescription drugs.

Next steps

As a result of this amendment, a veterinary product containing moxidectin that is sold for use in dogs, cats or ferrets will be considered a prescription drug subject to the Food and Drug Regulations (FDR). Since the veterinary drugs containing moxidectin for these uses are already licensed as prescription drugs, there should be no impact to market authorization holders or the public.

Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on this update to the Prescription Drug List, please contact:

Health Canada
Pharmaceutical Drugs Directorate
Office of Science
E-mail: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca