Health product highlights 2021: Annexes of products approved in 2021

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Drugs for human use: Approved in 2021

This section outlines the new drugs, generic drugs and biosimilars approved for sale in Canada in 2021, and the safety updates issued.

Health categories

The drugs listed have been divided into categories according to the Anatomical Therapeutic Chemical Classification System, a system of codes developed by the World Health Organization. These codes are often assigned according to the mechanism of action (that is, how the drug works) rather than the disease or condition to be treated.

We have included the indication of each new drug to give you some additional information. In addition, each new drug has a hyperlink to the Decision Summary (when available). These documents provide a brief overview of the rationale for our decision to approve the drug.

The categories are:

Important definitions

Aligned review
An aligned review is one where the drug company allowed information to be shared between Health Canada and health technology assessment organizations.
Approved under an interim order
This indicates the drug was approved under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
Biologic drug
Biologic drugs are biologically-derived products such as vaccines, blood-derived products and products produced through biotechnology.
Biosimilar
A biosimilar is a biologic drug that enters the market subsequent to a previously authorized biologic drug in Canada with a demonstrated similarity to the previously authorized biologic drug.
COVID-19
This indicates the drug was approved for use in the treatment or prevention of COVID-19.
Extraordinary use new drug
Health Canada recognizes that there are circumstances in which manufacturers cannot reasonably provide substantial evidence demonstrating the safety and efficacy of a therapeutic product as there are logistical or ethical challenges in conducting the appropriate human clinical trials. For these types of products, which may be needed as part of emergency preparedness in Canada, the regulations for Extraordinary Use New Drugs (EUNDs) allow for the possibility of a market authorization based primarily on animal data. Once a product has received market authorization as an EUND, the sale of the product for that indication is restricted to federal, provincial and territorial, and municipal government(s).
Generic drug
A generic drug is a copy of a brand name product. Generic drugs contain the same medicinal ingredients as the brand name drug and are considered bioequivalent to the brand name drug. There may be many generic versions of one brand name drug. Generic drugs cost less, so approving generic drugs can mean considerable savings to the health care system.
New active substance
A new drug that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient.
New drug
New drugs give new and innovative options for treatment, prevention and diagnosis of various health conditions.
Notice of Compliance with conditions
A Notice of Compliance may be issued with Conditions (NOC/c) to a drug with promising clinical benefit, for a serious, life-threatening, or severely debilitating disease or condition. The manufacturer must still demonstrate that the product has an acceptable safety profile based on a benefit/risk assessment, and is of high quality, and also commits to undertake additional studies to verify the clinical benefit of the drug. Submissions that are reviewed under this pathway are subject to shorter review targets.
Orphan drug
Orphan drugs are used to treat rare diseases, and have received orphan designation in either the United States or the European Union.
Pediatric indication
This indicates that the drug has been approved for use in children less than 18 years old.
Priority review
Priority review status may be granted to a drug submission for a product for a serious, life-threatening, or severely debilitating disease or condition. Submissions that are granted priority review status are subject to shorter review targets.
Review with international partners
A review with international partners is one where Health Canada worked with certain regulators to share the work of drug reviews.
Safety updates
Safety updates are designed to communicate information about potential health risks, so that patients and health care professionals can make informed decisions about their health.

You can report adverse drug reactions to your medical professional, to a hospital or to the company that made the product. You can also report them to Health Canada through the Canada Vigilance Program or by phone at 1-866-234-2345.

New drugs, new generic drugs and new biosimilars approved in 2021

Alimentary tract and metabolism

For example, drugs for the gastrointestinal tract and drugs for diabetes.

7 new drugs

Dojolvi
Lyumjev

Decision Summary

The treatment of adults with diabetes mellitus who require insulin for the control of high blood sugar. The treatment of people with type 2 diabetes, generally used in combination with an intermediate- or long-acting insulin for the control of high blood sugar.

Nexviazyme

Decision Summary

Octasa

Decision Summary

Vitamin D3 oral solution

Decision Summary

Waymade-Trientine

Decision Summary

Wegovy

Decision Summary

1 new biosimilar

Kirsty

Decision Summary

16 new generic drugs

Antiinfectives for systemic use

For example, antibacterials, antivirals and vaccines.

9 new drugs

Comirnaty

Decision Summary

Foclivia

Decision Summary

Janssen COVID-19 vaccine

Decision Summary

Rukobia
Spikevax

Decision Summary

Supemtek

Decision Summary

Tpoxx
Vaxneuvance

Decision Summary

Vaxzevria

Decision Summary

15 new generic drugs

Safety updates

Pfizer-BioNTech COVID-19 Vaccine:

Dear Healthcare Professional Letter: Pfizer-BioNTech COVID-19 Vaccine: Updated Dosage and Administration and Post-Market Adverse Reaction Information

Dear Healthcare Professional Letter: Pfizer-BioNTech COVID-19 Vaccine: Updated Storage and Transportation Conditions

Health Product Risk Communication: COMIRNATY (COVID-19 Vaccine, mRNA, also referred to as Pfizer-BioNTech COVID-19 Vaccine): New Formulation for Use in Children Aged 5 Years to Less Than 12 Years

COVID-19 Vaccine Moderna:

Dear Healthcare Professional Letter: COVID-19 Vaccine Moderna: Updated English-only Global Vial and Carton Labels and Post-Market Adverse Reaction Information

Health Product Risk Communication: Importation of COVID-19 Vaccine Moderna with up to 15 Doses per Vial and English-only Vial and Carton Labels (US-Labelled Supply)[updated June 24, August 3 and October 29]

AstraZeneca COVID-19 Vaccine:

Dear Healthcare Professional Letter: Authorization of AstraZeneca COVID-19 Vaccine with English-only Vial and Carton Labels

Dear Healthcare Professional Letter: Importation of AstraZeneca COVID-19 Vaccine with English-only Vial and Carton Labels (US-Labelled Supply)

Covishield:
Dear Healthcare Professional Letter: Authorization of COVISHIELD with English-only Vial and Carton Labels

AstraZeneca COVID-19 Vaccine and Covishield:

Dear Healthcare Professional Letter: AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Thrombosis with Thrombocytopenia

Dear Healthcare Professional Letter: AstraZeneca COVID-19 Vaccine and COVISHIELD: Risk of Capillary Leak Syndrome

Janssen COVID-19 Vaccine:

Dear Healthcare Professional Letter: Authorization of Janssen COVID-19 Vaccine with English-only Vial and Carton Labels

Dear Healthcare Professional Letter: Importation of Janssen COVID-19 Vaccine with Two Types of English-only Vial and Carton Labels

Dear Healthcare Professional Letter: Janssen COVID-19 Vaccine and the Risk of Thrombosis with Thrombocytopenia

Health Product Risk Communication: Importation of Janssen COVID-19 Vaccine with European Union (EU) English-only Vial and Carton Labels

Bamlanivimab:
Dear Healthcare Professional Letter: Bamlanivimab - Potential Risk of Treatment Failure Due to Circulation of Resistant SARS-CoV-2 Variants

Casirivimab and Imdevimab: Dear Healthcare Professional Letter: Authorization of Casirivimab and Imdevimab with English-only Labels for Use in Relation to the COVID-19 Pandemic

Sotrovimab:
Dear Healthcare Professional Letter: Authorization of Sotrovimab for Injection for Use in Relation to the COVID-19 Pandemic

Spikevax: Health Product Risk Communication: Distribution of SPIKEVAX (elasomeran) COVID-19 Vaccine with English-only Vial and Carton Labels

Antineoplastic and immunomodulating agents

For example, drugs for the treatment of cancer and drugs that stimulate or suppress the immune system.

27 new drugs

Abecma

Decision Summary

Braftovi
Brukinsa
Camcevi
Enhertu

Decision Summary

Gavreto
Ilumya

Decision Summary

Jemperli
Kesimpta

Decision Summary

Ledaga
Lumakras

Decision Summary

Mektovi
Minjuvi

Decision Summary

Onureg
Padcev

Decision Summary

Pemazyre

Decision Summary

Phesgo

Decision Summary

Ponvory

Decision Summary

Retevmo
Saphnelo

Decision Summary

Tecartus

Decision Summary

Tepmetko
Trecondyv
Trodelvy

Decision Summary

Truseltiq
Vyxeos
Zepzelca

10 new biosimilars

Abevmy

Decision Summary

Adalimumab injection

Decision Summary

Aybintio

Decision Summary

Bambevi

Decision Summary

Ixifi

Decision Summary

Nypozi

Decision Summary

Riabni

Decision Summary

Simlandi

Decision Summary

Yuflyma

Decision Summary

Zirabev

Decision Summary

48 new generic drugs

Safety updates

Gilenya (fingolimod):
Health Product Risk Communication: GILENYA (fingolimod) – Risk of Liver Injury

Antiparasitic products, insecticides and repellants

For example, drugs to treat infestations of parasites.

1 new generic drug

Blood and blood forming organs

For example, drugs such as anticoagulants.

4 new drugs

Glassia
Reblozyl

Decision Summary

Triferic Avnu
Vistaseal

Decision Summary

6 new generic drugs

Cardiovascular system

For example, drugs for high blood pressure and anticholesterol agents.

3 new drugs

Leqvio
Opsynvi
Vyndamax

17 new generic drugs

Dermatologicals

For example, drugs to treat psoriasis.

2 new drugs

Adtralza

Decision Summary

Arazlo

Decision Summary

3 new generic drugs

Genito urinary system and sex hormones

For example, hormonal contraception and drugs for the urinary tract system.

5 new drugs

Inprosub
Nextstellis
Osphena
Slynd
Vablys

Decision Summary

11 new generic drugs

Musculo-skeletal system

For example, drugs such as anti-inflammatories and muscle relaxants.

2 new drugs

Evrysdi
Myinfla

5 new generic drugs

Nervous system

For example, analgesics and antidepressants.

3 new drugs

Sunosi
Vyepti

Decision Summary

Wakix

Decision Summary

14 new generic drugs

Safety updates

Hydromorphone injectable formulations:
Dear Healthcare Professional Letter: Importation of German-labelled Hydromorphone Ethypharm Kalceks (Hydromorphone Hydrochloride Solution for Injection) due to Potential Shortage of Canadian-labelled HYDROmorphone

Suboxone:
Dear Healthcare Professional Letter: Important Safety Information on SUBOXONE (buprenorphine and naloxone) and the Risk of Overdose or Underdose when Switching Between Dosage Forms or Routes of Administration

Ruzurgi (amifampridine):
Dear Healthcare Professional Letter: RUZURGI (amifampridine) - Removal from Canadian Market: Options for Continued Treatment for Lambert-Eaton Myasthenic Syndrome[updated June 25, 2021]

Champix (varenicline):
Dear Healthcare Professional Letter: CHAMPIX (varenicline) — Potential Risk Posed by Long-Term Exposure to Nitrosamine Impurity, N-nitrosovarenicline, Exceeding Acceptable Intake Limit

Respiratory system

For example, drugs to treat asthma and antihistamines.

2 new drugs

Breztri Aerosphere

Decision Summary

Trikafta

Decision Summary

3 new generic drugs

Sensory organs

For example, drugs to treat vision loss.

2 new drugs

Cequa

Decision Summary

Tissueblue

3 new generic drugs

Systemic hormonal preparations, excluding sex hormones and insulins

For example, drugs to treat hypothyroidism.

1 new drug

Ngenla

Decision Summary

2 new generic drugs

Various

For example, drugs unable to be classified into the other categories such as diagnostic agents.

3 new generic drugs

Medical devices: Approved in 2021

There are different classes of medical devices, ranging from Class I to IV. Class I devices are considered low-risk devices, for example, a tongue depressor. Class IV devices present the greatest potential risk, for example, a pacemaker.

This section outlines the new Class IV medical devices approved for sale in Canada in 2021, and the safety updates issued.

Health categories

The medical devices listed have been divided into categories according to the Global Medical Device Nomenclature system for naming and grouping medical devices.

We have included the indication of each new medical device to give you some additional information. In addition, each new device has a hyperlink to the Decision Summary (when available). These documents provide a brief overview of the rationale for our decision to approve the medical device.

The categories are:

Important definitions

License with conditions
A medical device license may be issued with conditions set out by Health Canada. For example, the manufacturer may be required to submit additional information on an on-going basis for the medical device to demonstrate that it continues to meet our regulatory requirements.
Medical device
Medical devices are products that are used for diagnostic and/or therapeutic purposes. Newly approved medical devices provide a broader range of products used to treat, manage, diagnose or prevent a disease or a physical condition.
Safety updates
Safety updates are designed to communicate information about potential health risks, so that patients and health care professionals can make informed decisions about their health.

You can report medical device incidents to your medical professional, to a hospital or to the company that made the product. You can also report them to Health Canada through the Canada Vigilance Program or by phone at 1-866-234-2345.

New class IV medical devices approved in 2021

Body fluid and tissue management devices

For example, blood separation systems.

2 new medical devices

Embocube Embolization Gelatin
Embotrap III Revascularization Device

Body tissue manipulation and reparation devices

For example, bone grafts and dermal dressings.

3 new medical devices

LegoGraft
Gem 21S Growth-Factor Enhanced Matrix
Salvinoss Collagen Xenograft + Collagen Bone Graft Material

Cardiovascular devices

For example, cardiovascular catheters and pacemakers.

23 new medical devices

Orsiro Sirolimus Eluting Coronary Stent System
Achieve Advance Mapping Catheter
Sapphire II Pro Balloon Dilatation Catheter
Stealth 360 Peripheral Orbital Atherectomy System
Heartstart Intrepid Monitor/Defibrillator
Alto Abdominal Stent Graft System
Soundbite Crossing System – Peripheral (14P)
Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System
Omniwire Pressure Guide Wire
ZOLL AED 3 Aviation
Triclip G4 System
Comet II Pressure Guidewire
Tornado Embolization Coils and Microcoils
Nester Embolization Coils and Microcoils
Mynx Control Vascular Closure Device
Synergy Megatron Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System
Mitris Resilia Mitral Valve
Reprocessed Diagnostic Ultrasound Catheter
Reprocessed Advisor HD Grid Sensor Enabled High Density Mapping Catheter
Epic Plus/Epic Plus Supra Stented Porcine Tissue Valves
Perclose Prostyle Suture-Mediated Closure and Repair System
Renamic Neo
Conquest 40 PTA Dilatation Catheter

Safety update

Medtronic Heartware Ventricular Assist Device System: Dear Healthcare Professional Letter: Medtronic Heartware Ventricular Assist Device System - Recall Due to Risk of Neurological Adverse Events, Mortality and Delay or Failure to Restart

In vitro diagnostic medical devices

For example, instrument/analyser and viral infection disease in vitro devices.

5 new medical devices

Mirasol Pathogen Reduction Technology (PRT) System
Alinity m HCV (Confirmatory)
Atellica IM HBc Total 2 (HBcT2) (donor screening for transplantation)
PK CMV-PA system
Vitros Immunodiagnostic Products Anti-HTVL-I/II Reagent, Calibrator and Control

Neurological devices

For example, neurological stimulation devices.

11 new medical devices

Wavewriter Alpha Spinal Cord Stimulator System
Vercise Genus Deep Brain Stimulation System
eCLIPs System
Wavewriter Alpha Spinal Cord Stimulator System – Alpha 16
Wavewriter Alpha Spinal Cord Stimulator System – Alpha Prime
Wavewriter Alpha Spinal Cord Stimulator System – Alpha Prime 16
Stereotactic TCD Electrodes
Vercise Genus P8 Deep Brain Stimulation System
Vercise Genus P32 Deep Brain Stimulation System
Vercise Genus R16 Deep Brain Stimulation System
Vercise Genus R32 Deep Brain Stimulation System

Plastic surgery and cosmetic devices

For example, breast implants.

1 new medical device

Nexus Ultrasonic Surgical Aspirator System

Various

Applicable to medical devices generally.

Safety update

Ultrasound gels and lotions:

Drugs for veterinary use: Approved in 2021

Important definitions

Generic drug
A generic drug is a copy of a brand name product. Generic drugs contain the same medicinal ingredients as the brand name drug and are considered bioequivalent to the brand name drug. There may be many generic versions of one brand name drug.
New active substance
A new drug that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient for veterinary use.
New drug
New drugs give new and innovative options for treatment, prevention and diagnosis of various health conditions.

You can report a veterinary drug reaction to Health Canada.

6 new drugs

NexGard Combo
Dormazolam
Solensia
Draxxin KP
Solofer
Librela

13 new generic drugs

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