Health Canada’s ongoing commitment to ensuring safe and effective medications is evident through its recent approvals. The following list includes new drugs, biosimilars, and dosage forms that received Notices of Compliance (NOC) in 2024 and early 2025. While these drugs are approved for the Canadian market, actual availability may vary depending on the manufacturer’s launch timeline. Always check with manufacturers or distributors for marketing details.
January 2025 Update
Several important drugs have been approved this month, reflecting advancements in both treatment options and drug formulations. Below are the most recent additions to the Health Canada drug approval list.
Recent Additions
1. Abilify Asimtufii (aripiprazole)
• Manufacturer: Otsuka Canada/Lundbeck
• Approval Date: 2025-01-17
• Route: Intramuscular (IM)
• Description: A new prolonged-release injectable suspension for the management of schizophrenia and bipolar disorder. This formulation requires administration every two months, providing a convenient option for patients with these chronic conditions. Full product monograph here.
• Manufacturer: Xediton Pharmaceuticals
• Approval Date: 2025-01-17
• Route: Oral/IV
• Description: A new fluoroquinolone antibiotic designed to treat acute bacterial skin and skin structure infections. Baxdela offers flexibility with both oral and intravenous administration options, supporting a range of treatment settings. Read the product details.
• Manufacturer: Novartis
• Approval Date: 2025-01-06
• Route: Oral
• Description: An immunomodulatory monotherapy for adults with paroxysmal nocturnal hemoglobinuria (PNH), particularly those experiencing hemolytic anemia. Fabhalta offers targeted therapy for a rare but serious blood disorder. Learn more about Fabhalta here.
4. Flumist (influenza virus vaccine, live attenuated)
• Manufacturer: AstraZeneca
• Approval Date: 2025-01-27
• Route: Intranasal
• Description: The trivalent formulation of Flumist returns, following its initial approval in 2010. This live attenuated influenza vaccine is expected to replace the quadrivalent formulation in the 2025/26 flu season, offering an alternative to traditional injectable vaccines. Access the full vaccine information here.
Overview of Health Canada Approvals Process
Health Canada’s drug approval process involves rigorous review of clinical trial data to ensure the safety, efficacy, and quality of new pharmaceuticals. Drugs that successfully meet these criteria are granted a Notice of Compliance (NOC), authorizing them for sale in Canada.
Staying Informed
For healthcare professionals and patients alike, staying updated on new drug approvals is crucial. These new medications offer advancements in the treatment of chronic conditions, infectious diseases, and rare disorders. Be sure to review full product monographs for detailed information on indications, dosage, and precautions.
By maintaining transparency and adhering to high standards, Health Canada continues to improve access to innovative therapies. Keep an eye out for monthly updates on newly approved drugs and dosage forms to stay ahead of developments in healthcare.