Update on New Drug and Medical Device Authorizations
News release
New Treatment Options for Canadians recently approved by Health Canada
January 23, 2019 - Ottawa, ON - Health Canada
Prescription drugs and medical devices are evolving quickly, and Canadians want access to the latest and most effective treatment options. They also want to know when Health Canada approves new drugs and medical devices, particularly when few or no other options are available to treat a particular disease or condition.
Health Canada is committed to providing Canadians with the information they need to make informed choices about their health and well-being.
Health Canada informs Canadians of new authorizations of drugs and Class IV medical devices (those representing the highest risk) via Twitter and LinkedIn using the hashtag #drugandmeddevice. Health Canada will now also provide quarterly updates listing the drugs and medical devices that have been authorized during the previous three months. This is part of the Department’s commitment to being transparent and keeping Canadians informed as new treatment options are authorized.
For more information, our 2017 Highlights Report on New Drugs and Medical Devices notes the many significant achievements of the year, including how Health Canada is continuing to make important medications and medical devices available to Canadians.
You can also learn more about what we are doing to support access to much-needed medicines and devices through our Regulatory Review of Drugs and Devices initiative.
These quarterly updates complement activities Health Canada is undertaking as part of its Medical Devices Action Plan, launched in December 2018, to provide more information to Canadians on medical devices.
We encourage you to follow @GovCanHealth to find out when new treatments are authorized by Health Canada. For people who are not yet following us on Twitter, our recent authorizations are listed below.
Additional Health Canada Resources for Information about Drugs and Medical Devices:
- 2017 Highlights Report on New Drugs and Medical Devices
- Report a Health and Safety Concern
- Health Canada’s Action Plan on Medical Devices
- New Safety and Effectiveness Reviews
- The Drug and Health Product Register
- MedEffect Canada
- Summary safety reviews
- Drug product database
Drugs and medical devices authorized since September 2018
| Date | Drug | Purpose |
|---|---|---|
| December 2018 | Brineura | For enzyme replacement therapy for pediatric patients with the rare disease Neuronal Ceroid Lipofuscinosis type 2 (CLN2). |
| December 2018 | Crysvita | To treat patients with low blood phosphate levels caused by the rare disease hypophosphataemia. |
| October 2018 | Edaravone | Following a priority review, approved to treat patients with Amyotrophic Lateral Sclerosis (ALS). |
| October 2018 | Takhzyro | To prevent attacks of hereditary angioedema (HAE) in patients with this rare and serious condition. |
| October 2018 | Tegsedi | The first approved treatment in Canada for adult patients with the rare disease hereditary transthyretin amyloidosis with stage 1 or 2 polyneuropathy. |
| Date | Drug | Purpose |
|---|---|---|
| November 2018 | Unituxin | To treat children with certain nerve cancers in combination with cytokines. |
| October 2018 | Jivi | For previously treated adults and adolescents with hemophilia A to prevent or reduce the frequency of bleeding. |
| September 2018 | Kymriah | A first-in-class gene therapy approved for children and young adults with a certain type of leukemia, and to treat adults with a certain type of lymphoma. |
| Date | Drug | Purpose |
|---|---|---|
| October 2018 | Orilissa | To help relieve pain from endometriosis, a painful disorder affecting the uterus, ovaries and other organs. |
| Date | Drug | Purpose |
|---|---|---|
| September 2018 | Olumiant | To help reduce signs and symptoms of moderate to severe rheumatoid arthritis in adult patients who do not tolerate other medications. |
| Date | Drug | Purpose |
|---|---|---|
| December 2018 | Biothrax | For emergency use by government bodies to vaccinate adult personnel at high risk of anthrax exposure. |
| November 2018 |
Kamrab | An immunoglobulin approved to treat patients who have come in contact with an animal suspected of being infected with rabies. |
| October 2018 | Pifeltro | For use along with other medicines to treat adults infected with HIV-1 virus. |
| September 2018 | Stromectol | To treat patients with parasite infections that may be acquired in high-risk regions or when travelling. |
| September 2018 | XYDALBA | An antibiotic used in the treatment of adult patients with serious bacterial infections of the skin. |
| Date | Drug | Purpose |
|---|---|---|
| October 2018 | Veltassa | To lower blood potassium levels in patients with chronic kidney disease and high blood potassium. |
| September 2018 | Monoferric | An injectable iron treatment approved for patients diagnosed with anemia from iron deficiency that is not manageable with oral supplements. |
| Date | Drug | Purpose |
|---|---|---|
| October 2018 | Xermelo | For use in combination with other drugs to treat patients with diarrhea associated with certain cancers that has not responded to standard therapy. |
| October 2018 | Folotyn | For the treatment of patients with a specific type of cancer – relapsed or refractory peripheral T-cell lymphoma (PTCL). |
| September 2018 |
Cabometyx | For certain adult patients with advanced renal cell carcinoma (RCC). |
| Date | Drug | Purpose |
|---|---|---|
| November 2018 | Belsomra | For the treatment of patients with insomnia. |
| Date | Drug | Purpose |
|---|---|---|
| October 2018 | Occlusin Embolization Microspheres | To treat certain cancers by blocking blood flow to tumour tissues. |
| September 2018 | Natrelle 133 Plus Microcell Tissue Expanders | To be used temporarily to help stretch tissues in patients requiring breast reconstruction or other similar surgeries. |
| Date | Drug | Purpose |
|---|---|---|
| December 2018 | Pipeline Flex Embolization Device with Shield Technology | For use with or without embolic coils for the treatment of wide neck intracranial aneurysms. |
| December 2018 | Heli-FX EndoAnchor System | To improve fixation and sealing of certain kinds of grafts in cardiac patients. |
| December 2018 | Embotrap II Revascularization Device | To restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. |
| December 2018 | MitraClip Delivery System | For heart patients requiring mitral valve repair rather than cardiac surgery. |
| November 2018 | WEB Aneurysm Embolization System | To treat aneurysms in a patient's brain. |
| November 2018 | Ascyrus Medical Dissection Stent (AMDS) | To treat cardiac patients with a variety of conditions affecting the aorta. |
| November 2018 | CoreValve Evolut PRO Transcatheter Aortic Valves | For use in cardiac patients requiring valve replacement. |
| October 2018 | iVascular Capturer Thrombus Extraction Catheter | To remove blood clots in patients undergoing heart surgeries. |
| October 2018 | Optima Coil System | To treat patients with brain aneurysms and conditions affecting blood vessels elsewhere in the body. |
| September 2018 | Ilivia 7 ICD (PROMRI) | To help treat irregular heartbeats in cardiac patients. |
| September 2018 | Defigard Touch 7 | To help treat irregular heartbeats in cardiac patients. |
| Date | Drug | Purpose |
|---|---|---|
| October 2018 | Guardian Sensor (3) | To continuously monitor glucose levels in patients with diabetes. |
| October 2018 | Minimed 670G | Following a priority review process, licensed to help patients with type 1 diabetes keep their blood sugar in target range longer. |
| Date | Drug | Purpose |
|---|---|---|
| December 2018 | Elecsys HIV Duo Donor Screening | For the in vitro qualitative determination of HIV 1 p24 antigen and antibodies to HIV 1. |
| October 2018 | Virotrol HIV-1 gO | To monitor precision of laboratory testing for HIV 1. |
| September 2018 | Alinity i Anti-HBs assay | To monitor protection against disease in patients vaccinated for Hepatitis B. |
| Date | Drug | Purpose |
|---|---|---|
| December 2018 | Straumann Cerabone | For patients requiring bone reconstruction in certain dental/periodontal procedures. |
| September 2018 | Straumann Jason Membrane | To support the regeneration of bones and gums in patients undergoing dental surgeries. |
| September 2018 | NovoMatrix Reconstructive Tissue Matrix | For patients requiring gum treatment in certain dental/periodontal procedures. |
Contacts
Media Inquiries:
Health Canada
(613) 957-2983
hc.media.sc@canada.ca
Public Inquiries:
(613) 957-2991
1-866 225-0709
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