Notice: Prescription Drug List (PDL): Multiple Additions [2017-06-23]

June 23, 2017
Our file number: 17-106422-736

The purpose of this Notice of Amendment is to notify the additions of Lixisenatide, Ozenoxacin and Reslizumab to the Human and Veterinary Prescription Drug Lists (PDL). 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.

Lixisenatide injection (ADLYXINE) is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus in combination with: metformin, a sulfonylurea (alone or with metformin), pioglitazone (alone or with metformin), a basal insulin (alone or with metformin) when the therapy listed above does not provide adequate glycemic control.

Ozenoxacin (OZANEX) is indicated for the topical treatment of impetigo in patients aged 2 months and older.

Reslizumab (CINQAIR) is indicated as an add-on maintenance treatment of adult patients with severe eosinophilic asthma who: are inadequately controlled with medium-to-high-dose inhaled corticosteroids and an additional asthma controller(s) (e.g., LABA) and have a blood eosinophil count of ≥400 cells/microliter (µL) at initiation of the treatment.

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 these amendments to the Prescription Drug List please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 343-998-9304
Facsimile: 613-941-1812
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca