Update on New Drug and Medical Device Authorizations

Accelerating new treatment options for Canadians

OTTAWA, July 22, 2019 /CNW/ - Canadians want access to the latest treatments for themselves, their family and their friends— especially for diseases and conditions where limited options are available. Health Canada works every day to give Canadians timely, safe and secure access to drugs and medical devices. Over the last four months, Health Canada has approved 16 new drugs and medical devices to treat a range of health issues (list available below).

Drug and Medical Device Highlights 2018 Twitter Image (CNW Group/Health Canada)

In June, we also released our Drug and Medical Device Highlights 2018 report, which lists all new drug and medical device approvals over the last year, and provides updates on clinical trial authorizations and post-market safety actions. The report also highlights new regulations we have introduced to better protect the health and safety of Canadians, and to keep pace with the rapidly changing technology of drug and medical devices.

As of March 2019, the Department now shares clinical information from drug submissions with Canadians through the new Clinical Information Portal following the review of each new drug submission. A list of available records appears in the tables below. Health Canada also makes information about drugs and medical devices already on the market available upon request, and adds this information to the portal. Beginning in 2021, the Department will also start releasing information on new medical device submissions.

Canadians can follow @GovCanHealth on Twitter to find out when Health Canada has authorized a new drug or medical device. For people who are not yet following us, our recent authorizations are listed below.

Drugs and medical devices authorized since April 2019

Drugs for Cancer and Rare Diseases
Date	Drug	Purpose
May 2019	Ogivri (trastuzumab)	For patients with certain types of breast or stomach cancer
June 2019	Onpattro (patisiran)	For adult patients with the rare disease hereditary transthyretin-mediated (hATTR) amyloidosis, to treat polyneuropathy   Approved through an expedited pathway
July 2019	Zejula	For women with certain types of ovarian and other cancers when other treatments have failed   Reviewed in partnership with Australia's Therapeutic Goods Administration
July 2019	Vitrakvi	For adults and children with the rare disease NTRK gene fusion tumours.    Since there are no other treatment options, the drug review for Vitrakvi was accelerated. Vitrakvi has a pediatric indication.
July 2019	Nerlynx	To prevent or delay return of breast cancer for women with certain types of early disease at higher risk of recurrence.

Drugs for General Use
Date	Drug	Purpose
May 2019	Tibella	For short-term use by women following menopause to help relieve hot flashes, flushing and night sweats
July 2019	Dacogen	For adults with certain types of MDS who can't be treated with stem cell transplant

General and Plastic Surgery Devices
Date	Device	Purpose
June 2019	DSM Biomedical Calcium Phosphate Cement with Microspheres	For patients requiring bone filler for gaps
June 2019	Codman Cerelink ICP Monitoring System	For patients who require monitoring of the pressure in and around the brain
June 2019	Quattro Bolt Tenodesis Screw	For patients whose bicep muscle must be reattached to the bone
June 2019	Hera W10 Diagnostic Ultrasound System	For patients who need general ultrasound examinations
July 2019	Valiant Navion Thoracic Stent Graft System	For patients who require repair of their aorta
July 2019	Cardinal Health Neurology Pack	For patients undergoing spinal surgery

Dental Health Devices
Date	Device	Purpose
June 2019	TS Port Angled Abutment	For patients with dental implants to support dentures
June 2019	G-Aenial Injectable	For patients who need dental restorations
June 2019	Bien-Air Waveone Gold Kit therapy	For patients who need a root canal

Clinical information on drugs published since April 2019
Date	Drug	Purpose
July 2019	Esbriet	For adults with idiopathic pulmonary fibrosis (IPF), a type of lung disease
July 2019	Odefsey	For adults infected with HIV-1

Clinical information on medical devices published since April 2019
Date	Device	Purpose
July 2019	Juvéderm Volbella with Lidocaine	Facial filler for patients undergoing cosmetic treatments.

Additional Health Canada Resources for Information about 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 
Clinical Information Portal

SOURCE Health Canada

Media Inquiries: Health Canada, [phone], [email protected]; Public Inquiries: [phone], 1-866 225-0709