Notice: Multiple additions to the Prescription Drug List (PDL) [2024-10-18]
October 18, 2024
Our file number: 24-109639-621
The purpose of this Notice of Amendment is to notify about the addition of danicopan, fruquintinib, ivosidenib, perfluorohexyloctane, velagliflozin, and vorasidenib to the Prescription Drug List (PDL) for human and veterinary use.
| Drugs containing any of the following | Including (but not limited to) | Qualifier |
|---|---|---|
| Danicopan or its salts | N/A | N/A |
| Fruquintinib or its salts | N/A | N/A |
| Ivosidenib or its salts | N/A | N/A |
| Perfluorohexyloctane | N/A | N/A |
| Velagliflozin or its derivatives | N/A | N/A |
| Vorasidenib or its salts | 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.
Fruzaqla (fruquintinib capsules) is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with or are not considered candidates for available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF agent, an anti-EGFR agent (if RAS wild-type), and either trifluridine-tipiracil or regorafenib.
Miebo (perfluorohexyloctane ophthalmic solution, 100% w/w) is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
Senvelgo (velagliflozin oral solution) is indicated for the reduction of hyperglycemia in cats with non-insulin dependent diabetes mellitus.
Tibsovo (ivosidenib) in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy. Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Voranigo (vorasidenib tablets) is indicated for:
- the treatment of Grade 2a astrocytoma or oligodendroglioma with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation or isocitrate dehydrogenase-2 (IDH2) mutation in adults and pediatric patients aged 12 years and older following surgical intervention.
Voydeya (danicopan tablets) is indicated:
- As an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who have residual hemolytic anemia due to extravascular hemolysis (EVH).
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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