Mid-year update: Drugs and medical devices approved in 2020
Learn about our work to support Canada's response to COVID-19, the new drugs and medical devices that Health Canada approved for sale in Canada and clinical information published.
On this page
- Message from the Assistant Deputy Ministers
- Our COVID-19 regulatory response
- Improving access to drugs for human use
- Improving access to drugs for veterinary use
- Improving access to medical devices
- Publicly released clinical information
- Adverse reactions and incidents
Message from the Assistant Deputy Ministers
We're pleased to provide you with an update on the key drugs and medical devices approved by Health Canada between January and June 2020.
Over the past 6 months, our focus has been mainly on supporting the fight against COVID-19. This pandemic has created an unprecedented demand on Canada's health care system. Health Canada has played a key role in Canada's response to COVID-19 by working with partners and stakeholders to ensure essential health products and medical supplies are available for Canadians.
Early on, we implemented innovative and agile measures to help prioritize and expedite the regulatory review of COVID-19 health products. We did this without compromising Canada's high standards for safety, efficacy and quality. We continue to work with domestic and international players to help accelerate the development and availability of drugs and vaccines that will prevent and treat COVID-19.
In addition to supporting Canada's response to COVID-19, we also continued to authorize many other drugs and medical devices. These health products are vital to the health and well-being of Canadians.
Lastly, we recently published our 5th annual Drug and Medical Devices Highlights Report. Please see Drug and Medical Device Highlights 2019: Helping you Maintain and Improve your Health to learn more about our accomplishments in 2019.
These extraordinary times have changed the way we work, collaborate and innovate. We will build on this experience to inform future approaches to regulation that promote innovation, regulatory agility and safety. Moving forward, we will continue to work with our partners to provide products and information that Canadians need to stay safe and healthy.
Associate Assistant Deputy Minister
Health Products and Food branch
Assistant Deputy Minister
Health Products and Food Branch
Our COVID-19 regulatory response
As the national regulator for health products, Health Canada plays an important role in Canada's response to the COVID-19 pandemic.
Our regulatory measures and guidance have allowed companies to put vital products such as personal protective equipment, testing devices and hand sanitizers into the hands of Canada's health care workers and the Canadian public quickly. They help expedite clinical trials that support the rapid development of potential COVID-19 treatments and vaccines. The exceptional importation of drugs and medical devices that Canadians rely on for their health has also helped to prevent and ease shortages.
These and other efforts by Health Canada have made a strong impact on Canada's public health response to COVID-19.
The health products sector and Canada's business community mobilized quickly. Health Canada collaborated with federal partners and international counterparts. Due to these collective efforts, we approved thousands of products between March and June. These products support areas of greatest need and include more than:
- 3,200 hand sanitizers and
- 149 hard-surface disinfectants
- 262 medical devices for patient safety and care, such as personal protective equipment, ventilators and decontamination devices
- 26 testing devices for diagnosing COVID-19 and detecting the antibodies produced in response to a COVID infection
- 40 clinical trials, including the first clinical trial in Canada for a COVID-19 vaccine
Visit our COVID-19 health products webpage to learn more about our COVID-19 regulatory response, such as emergency measures, key regulatory guidance and approved products.
We're working with industry, health care professionals and regulatory partners to monitor the real-world effectiveness of products once they're approved. We're also taking proactive measures to protect Canadians from those products that make false or misleading COVID-19 claims.
Finally, we continue to leverage international collaborations to inform our regulatory strategies while contributing to global solutions for COVID-19.
Improving access to drugs for human use
In addition to our response to COVID-19, Health Canada continues to authorize products that are vital to the health and well-being of Canadians. Over the past 6 months, we authorized a number of new drugs to improve available treatment options.
Among these authorizations, we approved a pediatric formulation for caffeine citrate in March. This drug meets a longstanding need for treating serious breathing problems that can occur in premature infants in neonatal intensive care units.
In collaboration with the Australia-Canada-Singapore-Switzerland Consortium, Health Canada worked with partners to approve new drugs and get them to the market quickly and efficiently. In February we approved Xofluza to treat influenza, in partnership with Australia and Switzerland.
This is only one example of how we work closely with our international regulatory partners to bring much-needed health products to Canadians. We will continue to play a leadership role at the global level to maintain Canada's world-class regulatory system.
We authorized 35 new drugs (including 7 new biosimilar drugs) and 63 new generic drugs since January 2020.
Alimentary tract and metabolism (for example, drugs for diabetes)
|April||Ibsrela (tenapanor)||Used to treat adults with irritable bowel syndrome with constipation|
|March||Rybelsus (semaglutide)||Used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus|
Anti-infectives for systemic use (for example, antivirals)
Cabenuva (cabotegravir, rilpivirine)
|Used to treat human immunodeficiency virus (HIV) in adults|
|For patients 12 years or older with uncomplicated flu (influenza)|
Antineoplastic and immunomodulating agent (for example, drugs to treat cancer)
|June||Enspryng (satralizumab)||Used to treat neuromyelitis optica spectrum disorders (NMOSD) in adult and adolescent patients who are anti-aquaporin-4 (AQP4) antibody positive|
|June||Tukysa (tucatinib)||Used to treat adults with a type of breast cancer that has spread to other parts of the body, is not operable and has not responded to earlier treatments|
|May||Ruxience (rituximab)||Biosimilar to Rituxan. Used for the treatment of certain types of lymphoma and leukemia (blood cancer)|
|April||Sarclisa (isatuximab)||Used for adult patients with certain types of blood cancer|
|April||Riximyo (rituximab)||Biosimilar to Rituxan. Indicated for the treatment of certain types of lymphoma and leukemia|
|April||Daurismo (glasdegib)||Used to treat acute myeloid leukemia (AML) that has not been treated before. Only used in adults who: are 75 years of age or older or cannot receive intensive chemotherapy|
|April||Ziextenzo (pegfilgrastim)||Biosimilar to Neulasta. Used to increase the number of certain white blood cells|
|April||Nivestym (filgrastim)||Biosimilar to Neupogen. Indicated to increase the number of certain blood cells|
|March||Avsola (infliximab)||Biosimilar to Remicade. Authorized for all indications as Canadian Reference Product|
|Used to treat a certain type of breast cancer, which has spread to other parts of the body, in postmenopausal women and in men|
|February||Kanjinti (trastuzumab)||Biosimilar to Herceptin. For adult patients with certain types of breast or gastric cancer|
|February||Nubeqa (darolutamide)||For patients with a certain type of prostate cancer that has not spread to other parts of the body, and that no longer responds to treatment or surgery|
|February||Mayzent (siponimod)||For adults with active secondary progressive multiple sclerosis|
|February||Rozlytrek (entrectinib)||Used to treat adult patients with a certain type of solid tumour if there are no other effective treatment options|
Blood and blood forming organs (for example, antithrombotic agents)
|February||Cablivi (caplacizumab)||Used to treat patients with a rare blood clotting disorder in which clots form in small blood vessels|
Genito urinary system and sex hormones (for example, hormonal contraceptives)
|May||Nexplanon (etonogestrol)||Used to prevent pregnancy in adult women for up to 3 years|
Nervous system (for example, antidepressants)
|May||Spravato (esketamine)||Used to treat adults with major depressive disorder that is moderate to severe and that has not responded to at least 2 courses of treatment|
|April||Ajovy (fremanezumab)||Used to prevent migraine in adults who have at least 4 migraine days per month|
|Used for patients with a rare heart disease known as transthyretin-related amyloidosis cardiomyopathy|
Sensory organs (for example, drugs for the eyes)
|Used for patients with an eye disorder called neovascular (wet) age-related macular degeneration (AMD)|
Systemic hormonal preparations, excluding sex hormones and insulins (for example, parathyroid hormones)
|January||Osnovu (Teriparatide)||Biosimilar to Forteo. Used for men and postmenopausal women with severe osteoporosis|
Improving access to drugs for veterinary use
Health Canada continues to work to protect human and animal health and the safety of Canada's food supply. We authorized 10 veterinary drugs since January 2020.
Veterinary drugs authorized (new drugs)
|June||Eradia (metronidazole)||Treats certain infections in dogs|
|April||Cosacthen (tetracosactide)||Used to assess adrenal gland function in dogs|
|April||Aservo equihaler (ciclesonide)||Alleviates the symptoms of severe asthma in horses|
|March||Amodip flavoured tablets (amlodipine besylate)||Used to reduce blood pressure in cats|
|March||Gonabreed (gonadorelin acetate)||Allows for fixed time artificial insemination in lactating dairy and beef cows|
|February||Comfortan (methadone hydrochloride)||Used to control pain following ovariohysterectomy and castration in cats|
Veterinary generic drugs authorized (new generic drugs)
|March||Fenicyl (florfenicol)||Used to treat bovine respiratory disease and other infections in cattle|
|March||Rheumocam (meloxicam)||Nonsteroidal anti-inflammatory drug for cattle|
|February||Torphadine (butorphanol tartrate)||Used for the relief of pain associated with colic in adult horses and yearlings|
|January||Evicto (selamectin)||Used to treat and control certain internal and external parasites, including heartworm prevention for cats and dogs|
Improving access to medical devices
In January 2020, we created the Medical Devices Directorate to regulate medical devices for human use. This new Directorate is responsible for the pre-market review and post-market surveillance of medical devices. The Directorate verifies the safety, effectiveness and quality of medical devices and monitors the evolving safety of devices already on the market. It is important that Canadians have access to effective devices while not being exposed to undue risks.
We have also continued to improve the safety of health products marketed in Canada. Our Action Plan on Medical Devices, launched in December 2018, outlines measures that will:
- improve how medical devices get on the market
- strengthen monitoring and follow-up and
- provide Canadians with more information about the medical devices they rely on
We licensed 21 new Class IV medical devices and 128 new Class III medical devices since January 2020.
Blood fluid and tissue management devices (for example, wound dressings)
|April||Myriad||Used to cover, protect and provide a moist wound environment|
|March||Puracol Plus||Wound dressing for wound healing|
Body tissue manipulation and reparation devices (for example, surgical systems)
|March||Regeneten Bioinductive Implant System||Implant used tomanage and protectrotator cuff tendon injuries|
|February||Sonopet IQ Ultrasonic Aspirator System||Used in surgical procedures where fragmentation, emulsification, and aspiration of soft and hard tissue is desirable|
Cardiovascular devices (for example, cardiovascular catheters)
|June||ACIST HDi System||Ultrasound examination of heart and surrounding blood vessels|
|June||EPStar Fixed Electrophysiology Catheter with Lumen and EPstar Electrophysiology Cable||Used to evaluate a variety of cardiac arrhythmias (irregular heart beat) at endocardial and intravascular (heart and blood vessel) sites|
|May||Wattson temporary pacing guidewire||Used to introduce and position catheters and other devices within the chambers of the heart|
|May||Ranger and Ranger SL Over-the Wire Paclitaxel-Coated PTA Balloon Catheter||Used in angioplasty procedures in the leg|
|April||ZOLL X Series Advanced||Used for defibrillation of patients in cardiac arrest|
|April||TriClip (Transcatheter Tricuspid Valve Repair) System||Used to reconstruct the tricuspid valve|
|April||Eluvia Over-the-Wire Drug Eluting Vascular Stent System||Improves the patency of the target vessel|
|April||SENTINEL Cerebral Protection System||Captures and removes thrombus/debris in transcatheter aortic valve replacement procedures|
|April||XIENCE Pro A Everolimus Eluting Coronary Stent System||Improves coronary artery luminal diameter in patients|
|March||Lotus Edge Valve System||Stent-mounted tissue valve prosthesis used to replace the aortic valve in minimally invasive heart procedure|
|February||Attain Stability Quad MRI Surescan 4798||Cardiac lead that conducts electricity from a pacemaker to the heart to keep the heart beating properly|
|January||VEGA Endocardial Pacing Lead||Senses heart activity or pace with electrical impulses|
|January||IntellaNav ST||Power temperature-controlled ablation catheter used to aid in abnormal heart rhythms|
In vitro diagnostic medical devices (for example, viral infection disease in vitro devices)
|May||ADVIA Centaur®HBc Total 2 (HBcT2) (donor screening for transplantation)||Detects antibodies to the hepatitis B virus in human blood|
|February||PK7400 TP HA reagent and controls||Detects antibodies to syphilis in human blood|
|January||Alinity S HIV Ag/Ab Combo Assay||Detects the human immunodeficiency virus (HIV) (p24 antigen) and antibodies to HIV type 1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human blood|
Publicly released clinical information
We now release the clinical information that was provided to us by companies, after we have made our final decision as to whether a drug or medical device can be sold in Canada. Clinical information on drugs and medical devices published since January is listed below. It is also available through our portal. Information about drugs and medical devices already on the market can be added to the portal upon request.
Clinical information published on drugs for human use
|June||Rinvoq||For adult patients with rheumatoid arthritis when treatment with methotrexate has not worked well or has not been well tolerated|
|June||Sativex||Used to treat symptomatic relief of neuropathic pain in adults|
|May||Foquest||Used to treat Attention Deficit Hyperactivity Disorder (ADHD) in adolescents and adults|
|May||Eprex||For adults and children in the treatment of anemia|
|May||Imfinzi||Used to treat patients with locally advanced non-small cell lung cancer (NSCLC)|
|May||Adcetris||For the treatment of relapsed or refractory Hodgkin lymphoma (HL) patients|
|May||Kymriah||Used to treat patients aged 3 to 25 with B-cell acute lymphoblastic leukemia and adult patients with large B-cell lymphoma|
|April||Yescarta||Used to treat adult patients with various B-cell lymphomas (blood cancers in the lymph node)|
|April||Forteo||Used to treat severe osteoporosis (bone loss) in adults|
|April||Emgality||Preventative treatment of migraines in adults|
|March||Talzenna||Therapy treatment for adult patients with certain types of breast cancer|
|March||Fiasp||Fast-acting insulin as part of the treatment regimen for diabetes|
|March||Bavencio||Used to treat adolescents and adults with a type of skin cancer, Merkel cell carcinoma (MCC)|
|March||Lipitor||Statin to lower blood pressure|
|February||Balversa||Used to treat adult patients with a specific type of urothelial cancer (UC)|
|February||Lescol XL||Statin to lower blood pressure|
|February||Ultomiris||Used to treat adult patients with a blood system disease called Paroxysmal Nocturnal Haemoglobinuria|
|February||Zejula||Used to treat eligible adult patients with ovarian cancer|
|February||Repatha||Used to treat hyperlipidemia (high LDL cholesterol)|
|January||Pravachol||Statin to lower blood pressure|
|January||Sativex||Used to treat symptomatic relief of neuropathic pain in adults|
|January||Lokelma||Used for adult patients who need to lower their blood potassium to a normal level|
|January||Zocor||Statin to lower blood pressure|
|January||Keytruda||Used to treat certain patients with advanced endometrial cancer|
|January||Serophene tab (50mg)||Used to treat female infertility (ovulatory failure)|
|January||Onpattro||Used to treat polyneuropathy in people with hereditary transthyretin-mediated amyloidosis|
Clinical information published on medical devices
|June||Exablate 2100||Ultrasound surgery system|
|March||Accu-chek inform II test strips||Blood glucose monitoring system component|
|March||Freestyle Libre Flash GMS||Blood glucose monitoring system|
|March||Accu-chek inform II||Blood glucose monitoring system component|
|February||Accu-chek mobile monitor||Blood glucose monitoring system component|
Adverse reactions and incidents
As of December 16, 2019, hospitals must now report all serious adverse drug reactions (ADRs) and medical device incidents (MDIs). Health Canada is the first regulator worldwide to take this major step. This new requirement increases the quality and quantity of data we receive, thereby ensuring we have the necessary information to detect and take action to reduce health risks to Canadians.
Over 800 hospitals across Canada are now required to report ADRs and MDIs. Since implementing this new mandate, the number of reports have increased every month. Since January, we've received 2,731 serious ADR reports and 2,673 MDI reports from hospitals. Compared to the same period last year, this reporting by hospitals represents a:
- 4.5-fold increase in the number of ADR reports and
- 12-fold increase in the number of MDIs
We're grateful to the many hard-working health care practitioners who are taking enhanced steps to protect Canadians from the risks of harmful products.
We're proud of the progress we've made to serve the needs of Canadians during these challenging times. We're also proud to have collaborated with our Canadian and international partners, in supporting Canada's response to combatting COVID-19.
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