Notice: Multiple additions to the Prescription Drug List (PDL) [2023-08-30]
August 30, 2023
Our file number: 23-107439-272
The purpose of this Notice of Amendment is to notify about the addition of andexanet alfa, cenobamate, clascoterone and phytomenadione (veterinary) to the Prescription Drug List (PDL) for human and/or veterinary use.
The new medicinal ingredients will be added to the human and veterinary parts of the PDL as the following:
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Andexanet alfa | N/A | N/A |
| Cenobamate or its salts | N/A | N/A |
| Clascoterone or its derivatives | N/A | N/A |
The new medicinal ingredient will be added to the veterinary part of the PDL as the following:
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Phytomenadione (Vitamin K1) | N/A | When used in an oral formulation for the treatment of a coagulopathy |
These additions are effective at the time of posting.
Rationale
A scientific review of these drugs against the criteria set out in C.01.040.3 of the Food and Drug Regulations indicates that these drugs require prescription status.
Hemophyt (phytomenadione) is indicated:
- For the maintenance treatment of anticoagulant poisoning in dogs following emergency vitamin K1 parenteral treatment in the presence of clinical coagulopathy; or
- As a sole agent for the treatment of subclinical coagulopathy caused by an anticoagulant poisoning.
Ondexxya (andexanet alfa) is indicated for:
- adult patients treated with FXa inhibitors (rivaroxaban or apixaban) when rapid reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.
Winlevi (clascoterone) is indicated for:
- the topical treatment of acne vulgaris in patients 12 years of age and older.
Xcopri (cenobamate tablets) is indicated as:
- adjunctive therapy in the management of partial-onset seizures in adults with epilepsy who are not satisfactorily controlled with conventional therapy.
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 regarding this notice, please contact:
Health Canada
Pharmaceutical Drugs Directorate
Bureau of Policy, Science and International Programs
Office of Science
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
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