Notice: Multiple additions to the Prescription Drug List (PDL) [2025-12-18]
December 18, 2025
Our file number: 25-108167-776
The purpose of this Notice of Amendment is to announce the addition of bempedoic acid, bexagliflozin, izenivetmab, lecanemab, oritavancin, pirtobrutinib, seladelpar, sepiapterin, toripalimab, and zuranolone to the Prescription Drug List (PDL) for human and/or veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Bempedoic acid | N/A | N/A |
| Lecanemab | N/A | N/A |
| Oritavancin or its salts | N/A | N/A |
| Pirtobrutinib or its salts | N/A | N/A |
| Seladelpar or its salts | N/A | N/A |
| Sepiapterin or its salts | N/A | N/A |
| Toripalimab | N/A | N/A |
| Zuranolone or its salts | N/A | N/A |
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Bexagliflozin | N/A | N/A |
| Izenivetmab | N/A | N/A |
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.
Bexacat (bexagliflozin) is indicated for the management of cats with non-insulin dependent diabetes mellitus to reduce hyperglycemia and to improve hyperglycemia-associated clinical signs.
Jaypirca (pirtobrutinib) is indicated as monotherapy for the treatment of adult patients with:
- mantle cell lymphoma (MCL) relapsed or refractory in patients who have previously received at least two lines of systemic therapy including a Bruton tyrosine kinase (BTK) inhibitor.
- chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor.
Lenivia (izenivetmab) is indicated for the alleviation of pain associated with osteoarthritis in dogs.
Leqembi (lecanemab for injection) is indicated for:
- The treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early Alzheimer's disease), who are apolipoprotein E ε4 (ApoE ε4) noncarriers or heterozygotes, and who have confirmed amyloid pathology.
Loqtorzi (toripalimab for injection) is indicated:
- in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or with recurrent, locally advanced nasopharyngeal carcinoma (NPC).
- as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy.
Lyvdelzi (seladelpar) is indicated for:
- the treatment of primary biliary cholangitis (PBC), in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in adults unable to tolerate UDCA.
Nilemdo (Bempedoic acid) is indicated for:
- Primary hyperlipidemia
- Nilemdo (bempedoic acid) is indicated for the reduction of low-density lipoprotein cholesterol (LDL-C) in adults with hyperlipidemia, i.e., heterozygous familial hypercholesterolemia (HeFH) and mixed dyslipidemias,
- as an adjunct to diet, in combination with statins, with or without ezetimibe and PCSK9 inhibitors, or
- as an adjunct to diet, as monotherapy in patients who cannot tolerate recommended statin therapy, with or without ezetimibe and PCSK9 inhibitors.
- Nilemdo (bempedoic acid) is indicated for the reduction of low-density lipoprotein cholesterol (LDL-C) in adults with hyperlipidemia, i.e., heterozygous familial hypercholesterolemia (HeFH) and mixed dyslipidemias,
- Prevention of cardiovascular events
- Nilemdo is indicated to reduce the risk of adverse cardiovascular events, defined as cardiovascular death, myocardial infarction, stroke, or coronary revascularisation, in adults at increased risk for these events.
- Nilemdo should be used with statin drug therapy, as tolerated, with or without ezetimibe and PCSK9 inhibitors. In patients unable to take statins at any dose, Nilemdo may be used as monotherapy, or combined with ezetimibe and/or PCSK9 inhibitors, as appropriate.
Oritiniv (oritavancin for injection) is indicated for:
- the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin susceptible isolates only).
Sephience (sepiapterin for oral suspension) is indicated for the treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU). Sephience is indicated in conjunction with a phenylalanine (Phe)-restricted diet.
Zurzuvae (Zuranolone) is indicated for:
- the treatment of moderate or severe postpartum depression (PPD) in adults following childbirth.
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