Notice: Multiple additions to the Prescription Drug List (PDL) [2025-06-24]
June 24, 2025
Our file number: 25-104183-77
The purpose of this Notice of Amendment is to notify about the addition of cipaglucosidase alfa, delafloxacin, elafibranor, lazertinib, omaveloxolone, repotrectinib, tapinarof, teplizumab, and teprotumumab to the Prescription Drug List (PDL) for human and veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Cipaglucosidase alfa | N/A | N/A |
| Delafloxacin or its salts | N/A | N/A |
| Elafibranor or its salts | N/A | N/A |
| Lazertinib or its salts | N/A | N/A |
| Omaveloxolone | N/A | N/A |
| Repotrectinib | N/A | N/A |
| Tapinarof | N/A | N/A |
| Teplizumab | N/A | N/A |
| Teprotumumab | 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.
Augtyro (repotrectinib capsules) is indicated for:
- Treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
Baxdela (delafloxacin) is indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following susceptible microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Staphylococcus haemolyticus, Staphylococcus lugdunensis, Streptococcus agalactiae, Streptococcus anginosus Group (including Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus), Streptococcus pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, and Pseudomonas aeruginosa.
Iqirvo (elafibranor) is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
Lazcluze (lazertinib) in combination with amivantamab is indicated for the first-line treatment of adult patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations.
Nduvra (tapinarof cream) is indicated for the topical treatment of plaque psoriasis in adults.
Pombiliti (cipaglucosidase alfa for injection) is indicated:
- in combination with the enzyme stabiliser OPFOLDA (65 mg miglustat capsule) for the treatment of adult patients with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency) weighing ≥ 40 kg.
Skyclarys (omaveloxolone) is indicated for the treatment of Friedreich's ataxia in patients 16 years of age and older.
Tepezza (teprotumumab for injection) is indicated in adults for the treatment of moderate to severe active Thyroid Eye Disease (TED).
Tzield (teplizumab) is indicated:
- to delay the onset of Stage 3 type 1 diabetes in adult and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes.
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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