Update on New Drug and Medical Device Authorizations - July 22, 2019

Accelerating new treatment options for Canadians

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).

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

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