Health product highlights 2021: Annexes of products approved in 2021

On this page:

• Drugs for human use: Approved in 2021
• Class IV medical devices: Approved in 2021
• Drugs for veterinary use: Approved in 2021

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:

• Alimentary tract and metabolism – for example, drugs for the gastrointestinal tract and drugs for diabetes.
• Antiinfectives for systemic use – for example, antibacterials, antivirals and vaccines.
• Antineoplastic and immunomodulating agents – for example, drugs for the treatment of cancer and drugs that stimulate or suppress the immune system.
• Antiparasitic products, insecticides and repellents – for example, drugs to treat infestations of parasites.
• Blood and blood forming organs – for example, drugs such as anticoagulants.
• Cardiovascular system – for example, drugs for high blood pressure and anticholesterol agents.
• Dermatologicals – for example, drugs to treat psoriasis.
• Genito urinary system and sex hormones – for example, hormonal contraception and drugs for the urinary tract system.
• Musculo-skeletal system – for example, drugs such as anti-inflammatories and muscle relaxants.
• Nervous system – for example, analgesics and antidepressants.
• Respiratory system – for example, drugs to treat asthma and antihistamines.
• Sensory organs – for example, drugs to treat vision loss.
• Systemic hormonal preparations, excluding sex hormones and insulins – for example, drugs to treat hypothyroidism.
• Various – for example, drugs unable to be classified into the other categories such as diagnostic agents.

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.

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

• Priority review
• New active substance
• Pediatric indication
• Orphan drug
• Medicinal Ingredient
  • Triheptanoin
• Indication
  • Dojolvi is indicated as a source of calories and fatty acids for the treatment of adults and pediatric patients with long-chain fatty acid oxidation disorders (LC-FAOD).

Lyumjev

• Biologic drug

Decision Summary

• Medicinal Ingredient
  • Insulin lispro
• Indication

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

• New active substance
• Biologic drug
• Pediatric indication
• Review with international partners
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Avalglucosidase alfa
• Indication
  • Nexviazyme is a medicine that is used to treat adults, children and adolescents who have a confirmed diagnosis of late-onset Pompe disease.

Octasa

• Orphan drug

Decision Summary

• Medicinal ingredient
  • Mesalamine
• Indication
  • Octasa (mesalamine or 5-aminosalicylic acid) is used to treat ulcerative colitis. This is a disease of the large bowel (colon) or back passage (rectum), in which the lining of the bowel becomes inflamed (red
    and swollen).

Vitamin D3 oral solution

Decision Summary

• Medicinal ingredient
  • Cholecalciferol 625 mcg (25,000 IU)
• Indication
  • Vitamin D3 Oral Solution is used to treat vitamin D deficiency. This is when your body does not have enough Vitamin D, which is used to build and maintain healthy bones.

Waymade-Trientine

• New active substance
• Pediatric indication
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Trientine hydrochloride
• Indication
  • Waymade-Trientine is used for the treatment of Wilson’s disease in those who cannot take the drug penicillamine.

Wegovy

• Biologic drug

Decision Summary

• Medicinal Ingredient
  • Semaglutid
• Indication
  • Wegovy is used for chronic weight management in addition to reduced calorie diet and
    increased physical activity in adults, who have: a BMI of 30 kg/m2 or greater (with obesity), or a BMI of 27 kg/m2 and less than 30 kg/m2 (overweight) and weight-related health problems.

1 new biosimilar

Kirsty

• Biologic drug
• Pediatric indication

Decision Summary

• Medicinal Ingredient
  • Insulin aspart
• Indication
  • The treatment of patients with diabetes mellitus who require insulin for the control of hyperglycemia.

16 new generic drugs

• 1 product containing hyoscine butylbromide
• 1 product containing alfacalcidol
• 3 products containing saxagliptin hydrochloride
• 1 product containing ondansetron
• 1 product containing glycopyrrolate
• 2 products containing metformin
• 1 product containing pioglitazone hydrochloride
• 1 product containing vancomycin hydrochloride
• 2 products containing metoclopramide hydrochloride
• 1 product containing ondansetron hydrochloride
• 1 product containing pantoprazole sodium
• 1 product containing domperidone maleate

Antiinfectives for systemic use

For example, antibacterials, antivirals and vaccines.

9 new drugs

Comirnaty

• New active substance
• Biologic drug
• COVID-19

Decision Summary

• Medicinal Ingredients
  • Tozinameran
• Indication
  • Comirnaty is a vaccine used to prevent COVID-19 disease caused by the SARS-CoV-2 virus. Comirnaty can be given to people from 5 years of age and older.

Foclivia

• Biologic drug
• Pediatric indication

Decision Summary

• Medicinal Ingredient
  • Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted with MF59C.1)
• Indication
  • Foclivia is a vaccine intended to be given to prevent influenza (flu) in an officially declared pandemic situation in individuals 6 months of age and older. Pandemic flu is a type of influenza that happens infrequently, but spreads rapidly around the world. It is caused by a new influenza virus to which people have no prior immunity. The signs of pandemic flu are similar to those of ordinary flu but may be more serious.

Janssen COVID-19 vaccine

• Biologic drug
• New active substance
• COVID-19

Decision Summary

• Medicinal Ingredient
  • AD26.COV2.S (recombinant)
• Indication
  • Janssen COVID-19 Vaccine is a vaccine used to prevent COVID-19 disease caused by the SARS-CoV-2 virus. Janssen COVID-19 Vaccine can be given to protect people aged 18 years and older.

Rukobia

• Priority review
• New active substance
• Medicinal Ingredients
  • 600 mg fostemsavir (as fostemsavir tromethamine)
• Indication
  • Rukobia is used to treat HIV (human immunodeficiency virus) infection in adults who have had difficulty in controlling their HIV with many other antiretroviral medicines. It is used in patients who have HIV that is resistant to many antiretroviral medicines. Rukobia is used in combination with other antiretroviral medicines.

Spikevax

• Biologic drug
• New active substance
• COVID-19

Decision Summary

• Medicinal Ingredient
  • Elasomeran (mRNA)
• Indication
  • Spikevax is a vaccine used to prevent the coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. It can be given to people aged 12 years and older.

Supemtek

• Biologic drug
• New active substance

Decision Summary

• Medicinal Ingredient
  • Quadrivalent Recombinant Influenza Vaccine
• Indication
  • Supemtek is a vaccine used to prevent influenza. This vaccine may be given to adults 18 years and older.

Tpoxx

• New active substance
• Pediatric indication
• Orphan drug
• Medicinal Ingredient
  • 200 mg Tecovirimat (as tecovirimat monohydrate)
• Indication
  • Tpoxx is used to treat smallpox disease. It can be given to people weighing at least 13 kg.

Vaxneuvance

• Biologic drug
• New active substance

Decision Summary

• Medicinal Ingredient
  • Pneumococcal 15-valent Conjugate Vaccine (CRM197 Protein), adsorbed
• Indication
  • Vaxneuvance is a vaccine for adults 18 years of age and older to help protect against invasive disease caused by 15 types of bacteria called pneumococcus. Invasive disease includes: an infection in the blood; an infection of the lungs (pneumonia) that comes with an infection in the blood; an infection of the coverings of the brain and spinal cord (meningitis). Vaxneuvance will not give you disease caused by pneumococcus. Vaxneuvance may not protect against diseases caused by types of pneumococcus that are not covered by the vaccine.

Vaxzevria

• Biologic drug
• New active substance
• COVID-19

Decision Summary

• Medicinal Ingredient
  • ChAdOx1-S [recombinant]
• Indication
  • Vaxzevria is a vaccine used to prevent the coronavirus disease 2019 (COVID-19) caused by the SARS-CoV-2 virus. It can be given to adults 18 years of age and older.

15 new generic drugs

• 1 product containing posaconazole
• 1 product containing ritonavir
• 1 product containing azithromycin dihydrate
• 2 products containing daptomycin
• 1 product containing ertapenem sodium
• 1 product containing abiraterone acetate
• 1 product containing atazanavir sulfate
• 1 product containing efavirenz, emtricitabine, tenofovir disoproxil fumarate
• 1 product containing emtricitabine, tenofovir disoproxil fumarate
• 1 product containing tenofovir disoproxil fumarate
• 1 product containing lamivudine
• 1 product containing linezolid
• 1 product containing amoxicillin, clavulanate potassium
• 1 product containing duranavir

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

• Biologic drug
• Priority review
• New active substance
• NOC with conditions
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Idecabtagene vicleucel
• Indication
  • Abecma is used to treat adults with a type of cancer called multiple myeloma which is a cancer of the bone marrow. It is given when your cancer has not responded to at least three different treatments or has come back after these treatments. It is used as a treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last therapy.

Braftovi

• New active substance
• Aligned review
• Orphan drug
• Medicinal Ingredient
  • Encorafenib
• Indication
  • Braftovi is used with a drug called binimetinib to treat adults with a type of skin cancer called melanoma. This type of skin cancer must have a change (mutation) in the BRAF gene, and spread to other parts of the body, or cannot be removed by surgery. Braftovi is also used with a drug called cetuximab to treat adults with a type of large intestine cancer called metastatic colorectal cancer (mCRC). This type of intestine cancer must have a change (mutation) in the BRAF gene, and spread to other parts of the body and has already been treated with other cancer drugs.

Brukinsa

• Priority review
• New active substance
• Orphan drug
• Medicinal Ingredient
  • Zanubrutinib
• Indication
  • Brukinsa is used to treat cancers such as: Waldenström’s Macroglobulinemia (WM) and Mantle Cell lymphoma (MCL). Brukinsa is only used in patients who already have received at least one treatment for MCL.

Camcevi

• Medicinal Ingredients
  • Leuprolide mesylate
• Indication
  • Camcevi is used for the treatment of adult patients with advanced prostate cancer.

Enhertu

• Biologic drug
• Aligned review
• New active substance
• NOC with conditions
• Review with international partners
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Trastuzumab deruxtecan
• Indication
  • Enhertu is used in adults who have: HER2-positive breast cancer that has spread to other parts of the body (metastatic) or cannot be taken out by surgery and also received prior trastuzumab emtansine (T-DM1). Enhertu (trastuzumab deruxtecan) is used in adults who have HER2-positive breast cancer that has spread to other parts of the body (metastatic) or cannot be taken out by surgery and also received prior trastuzumab emtansine (T-DM1).

Gavreto

• New active substance
• NOC with conditions
• Review with international partners
• Orphan drug
• Medicinal Ingredient
  • Pralsetinib
• Indication
  • For the following indication Gavreto has been approved with conditions (NOC/c). Gavreto is used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC). The non-small cell lung cancer: is caused by abnormal Rearranged During Transfection (RET) gene(s) and cannot be removed by surgery or has spread to other parts of the body. A test will be done to determine if the non-small cell lung cancer is caused by RET genes.

Ilumya

• Biologic drug
• Aligned review
• New active substance

Decision Summary

• Medicinal Ingredient
  • Tildrakizumab
• Indication
  • Ilumya is a prescription medicine used to treat adults with moderate to severe plaque psoriasis, an inflammatory condition affecting the skin and nails. Plaque psoriasis can cause raised, thick, red and scaly patches (“psoriatic lesions”) that can appear anywhere on your body.

Jemperli

• Biologic drug
• Aligned review
• New active substance
• NOC with conditions
• Medicinal Ingredient
  • Dostarlimab
• Indication
  • For the following indication(s), Jemperli has been approved with conditions (NOC/c). Jemperli is a prescription medicine used in adults to treat: a kind of cancer called endometrial cancer (cancer of the lining of the womb) in adults that is shown by a laboratory test to be mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) that has progressed on or following prior treatment with a platinum containing regimen.

Kesimpta

• Biologic drug
• Aligned review
• Review with international partners

Decision Summary

• Medicinal Ingredient
  • Ofatumumab
• Indication
  • Kesimpta is used for the treatment of adults with relapsing remitting multiple sclerosis.

Ledaga

• Orphan drug
• Medicinal Ingredient
  • Chlormethine hydrochloride
• Indication
  • Ledaga is a medicine used on the skin (topical) to treat adults: with Stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) who have received previous skin treatment. Ledaga is not approved for use in children and adolescents under 18 years of age.

Lumakras

• New active substance
• NOC with conditions
• Reviewed with international partners
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Sotorasib
• Indication
  • For the following indication Lumakras has been approved with conditions (NOC/c). Lumakras is used to treat adults with non-small cell lung cancer (NSCLC) with an abnormal gene called KRAS G12C. This cancer cannot be removed by surgery or other treatment, or has spread to other parts of the body, and has been treated with at least one type of cancer treatment before. Lumakras is not approved for use in children and adolescents under 18 years of age.

Mektovi

• Aligned review
• New active substance
• Orphan drug
• Medicinal Ingredient
  • Binimetinib
• Indication
  • Mektovi is used with a drug called encorafenib to treat adults with a type of skin cancer called melanoma. This type of skin cancer must have a change (mutation) in the BRAF gene, and spread to other parts of the body, or cannot be removed by surgery.

Minjuvi

• Biologic drug
• New active substance
• NOC with conditions
• Reviewed with international partners
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Tafasitamab
• Indication
  • For the following indication, Minjuvi has been approved with conditions (NOC/c). Minjuvi (tafasitamab for injection) is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, who are not eligible for autologous stem cell transplant (ASCT).

Onureg

• Priority review
• Orphan drug
• Reviewed with international partners
• Medicinal Ingredient
  • Azacitidine
• Indication
  • Onureg is a nucleoside metabolic inhibitor indicated for maintenance therapy in adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction therapy with or without consolidation treatment, and who are not eligible for hematopoietic stem cell transplantation (HSCT).

Padcev

• Biologic drug
• Priority review
• New active substance
• Aligned review
• Reviewed with international partners

Decision Summary

• Medicinal Ingredient
  • Enfortumab vedotin
• Indication
  • Padcev is a medicine used to treat adults with bladder cancer and cancer of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery. Padcev may be used if you have received chemotherapy that contains platinum and an immunotherapy medicine.

Pemazyre

• Aligned review
• New active substance
• NOC with conditions
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Pemigatinib
• Indication
  • For the following indication, Pemazyre has been approved with conditions (NOC/c). Pemazyre is used to treat adults with a type of cancer called cholangiocarcinoma (bile duct cancer) when it: has a type of abnormality in a specific gene called Fibroblast Growth Factor Receptor 2 (FGFR2); and has been treated previously cannot be removed with surgery; and is at an advanced stage or has spread to other parts of the body (called metastatic). A test will be done to find out if the cancer has an FGFR2 gene abnormality.

Phesgo

• Biologic drug

Decision Summary

• Medicinal Ingredients
  • Pertuzumab, trastuzumab
• Indication
  • Phesgo is used to treat people with breast cancer when: there are a large number of “HER2-positive” cancer cells involved; the cancer has spread to areas near the breast or to other parts of your body (metastasized); the cancer may have advanced in one region and has not spread to other parts of the body and treatment is going to be given before surgery (treatment before surgery is called neoadjuvant therapy); or the cancer has not spread to other parts of the body and treatment is going to be given after surgery (treatment after surgery is called adjuvant therapy). As well as Phesgo you will also receive medicines called chemotherapy.

Ponvory

• New active substance

Decision Summary

• Medicinal Ingredient
  • Ponesimod
• Indication
  • Ponvory is used to treat adults with relapsing remitting Multiple Sclerosis (RRMS).

Retevmo

• New active substance
• Aligned review
• NOC with conditions
• Pediatric indication
• Reviewed with international partners
• Orphan drug
• Medicinal Ingredient
  • Selpercatinib
• Indication
  • For the following indications, Retevmo has been approved with conditions (NOC/c). Retevmo is used to treat certain cancers caused by abnormal RET genes in: adults with a type of lung cancer called non-small cell lung cancer (NSCLC). It is used when your cancer has spread to other parts of your body. Adults and children 12 to 17 years old with medullary thyroid cancer. It is used when: your cancer is advanced or has spread to other parts of your body, and your cancer cannot be removed using surgery. Adults with differentiated thyroid cancer. It is used when: your cancer is advanced or has spread to other parts of your body, your cancer cannot be removed using surgery, radioactive iodine therapy did not work, is no longer working or is not appropriate, and you have tried treatment with sorafenib and/or lenvatinib.

Saphnelo

• Biologic drug
• New active substance
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Anifrolumab
• Indication
  • Saphnelo is used for the treatment of: active lupus (systemic lupus erythematosus, SLE) in adults whose disease is not well controlled by other standard therapies (oral corticosteroids and/or immunosuppressants and/or antimalarials) they are also receiving. You will be given Saphnelo as well as your standard therapy for lupus. Lupus is a disease in which the immune system (the system that fights infection) attacks your own cells and tissues, causing inflammation and organ damage.

Tecartus

• Biologic drug
• Priority review
• New active substance
• Aligned review
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Brexucabtagene autoleucel
• Indication
  • Tecartus is a treatment for your mantle cell lymphoma – a form of white blood cell cancer. It is used when at least two other available medicines have stopped working for you.

Tepmetko

• New active substance
• NOC with conditions
• Reviewed with international partner(s)
• Medicinal Ingredient
  • Tepotinib (as tepotinib hydrochloride)
• Indication
  • Tepmetko is used to treat a type of lung cancer called non-small cell lung cancer (NSCLC). It is used in adults: whose cancer has spread to other parts of the body or is advanced and cannot be removed by surgery, and whose tumors have a specific change (abnormality) in the mesenchymal epithelial transition (MET) gene.

Trecondyv

• Priority review
• Orphan drug
• Medicinal Ingredient
  • Treosulfan
• Indication
  • Trecondyv is used together with fludarabine to prepare patients for a blood stem cell transplant from a donor: in adults with the blood cancers Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) who are not able to tolerate the standard preparation therapies, in children and adolescents older than one year of age with AML or MDS.

Trodelvy

• Biologic drug
• Priority review
• New active substance
• Aligned review
• Reviewed with international partner(s)
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Sacituzumab govitecan
• Indication
  • Trodelvy is a prescription medicine used to treat adults 18 years or older with breast cancer that is: estrogen and progesterone hormone receptor (HR) negative, and human epidermal growth factor receptor 2 (HER2)-negative (also called triple-negative breast cancer), and that has spread to other parts of the body or cannot be removed by surgery (metastatic), and who previously received two or more prior therapies, at least one of them for metastatic disease.

Truseltiq

• New active substance
• NOC with conditions
• Reviewed with international partner(s)
• Orphan drug
• Medicinal Ingredient
  • Infigratinib (as infigratinib phosphate)
• Indication
  • For the following indication Truseltiq has been approved with conditions (NOC/c). Truseltiq is used to treat adult patients with a type of cancer called cholangiocarcinoma (bile duct cancer) when it: has a type of abnormality in a specific gene called Fibroblast Growth Factor Receptor 2 (FGFR2); and has been treated previously, it cannot be removed with surgery, and is at an advanced stage or has spread to other parts of the body (called metastatic). A test will be done to find out if the cancer has an FGFR2 abnormality.

Vyxeos

• Priority review
• Orphan drug
• Medicinal Ingredients
  • Daunorubicin, cytarabine
• Indication
  • Vyxeos is used to treat adults with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Zepzelca

• New active substance
• NOC with conditions
• Reviewed with international partner(s)
• Orphan drug
• Medicinal Ingredient
  • Lurbinectedin
• Indication
  • For the following indication(s) Zepzelca has been approved with conditions (NOC/c). Zepzelca is used to treat a type of cancer called Stage III or metastatic small cell lung cancer (SCLC). It is used in adults who have received treatment with chemotherapy that contains platinum and it did not work or is no longer working.

10 new biosimilars

Abevmy

• Biologic drug
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Bevacizumab
• Indication
  • Abevmy is used in combination with a specific type of chemotherapy ([5-FU)-based chemotherapy) for first time treatment of people diagnosed with metastatic colorectal cancer. Abevmy is used in combination with a specific type of chemotherapy (carboplatin and paclitaxel) for the treatment of people diagnosed with metastatic non small cell lung cancer. Abevmy is used in combination with a specific type of chemotherapy (paclitaxel, topotecan, or pegylated liposomal doxorubicin) for the treatment of people diagnosed with recurrent, platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than two prior chemotherapy regimens. Abevmy is used in combination with lomustine (a specific type of chemotherapy) for the treatment of patients with a particular type of brain cancer called glioblastoma in which the cancer recurred after a previous treatment.

Adalimumab injection

• Biologic drug

Decision Summary

• Medicinal Ingredient
  • Adalimumab
• Indication
  • Abrilada (adalimumab injection) treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult and pediatric (13 to 17 years of age weighing ≥ 40 kg) Crohn’s disease (CD), ulcerative colitis (UC), adult and adolescent (12 to 17 years of age weighing ≥ 30 kg) hidradenitis suppurativa (HS), psoriasis (Ps) or adult and pediatric uveitis and familiar with the Abrilada efficacy and safety profile.

Aybintio

• Biologic drug
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Bevacizumab
• Indication
  • Aybintio is used in combination with a specific type of chemotherapy (intravenous 5-fluorouracil [5-FU]-based chemotherapy) for treatment of people diagnosed with metastatic colorectal cancer for the first time. Aybintio is used in combination with a specific type of chemotherapy (carboplatin and paclitaxel) for the treatment of people diagnosed with metastatic non-small cell lung cancer. Aybintio is used in combination with a specific type of chemotherapy (carboplatin and gemcitabine) for the treatment of people diagnosed with recurrent, platinum-sensitive, epithelial ovarian, fallopian tube, or primary peritoneal cancer that comes back at least 6 months after the last time the patient responded to a chemotherapy regimen containing a platinum agent. Aybintio is used in combination with a specific type of chemotherapy (paclitaxel, topotecan or pegylated liposomal doxorubicin) for the treatment of people diagnosed with recurrent, platinum-resistant, epithelial ovarian, fallopian tube or primary peritoneal cancer who received no more than two prior chemotherapy regimens. Aybintio is used in combination with lomustine (a specific type of chemotherapy) for the treatment of patients with a particular type of brain cancer called glioblastoma in which the cancer recurred after a previous treatment.

Bambevi

• Biologic drug
• Aligned review
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Bevacizumab
• Indication
  • Metastatic Colorectal Cancer: Bambevi is used in combination with a specific type of chemotherapy (intravenous 5-fluorouracil [5-FU]-based chemotherapy) for treatment of patients diagnosed with metastatic colorectal cancer for the first time. Metastatic colorectal cancer is cancer of the colon or rectum that has spread to other organs in the body.
  • Metastatic Lung Cancer: Bambevi is used in combination with a specific type of chemotherapy (carboplatin and paclitaxel) for the treatment of people diagnosed with metastatic non-small cell lung cancer. Metastatic non-small cell lung cancer is cancer of the lungs that has spread to other organs in the body.
  • Recurrent Platinum-Resistant Ovarian Cancer: Bambevi is used in combination with a specific type of chemotherapy (paclitaxel, topotecan, or pegylated liposomal doxorubicin) for the treatment of people diagnosed with recurrent, platinum-resistant, epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens. Recurrent platinum-resistant ovarian cancer is the type of cancer that progresses within 6 months after the last time the patient responded to chemotherapy regimen containing a platinum agent.
  • Recurrent Glioblastoma: Bambevi is used in combination with lomustine (a specific type of chemotherapy) for the treatment of patients with a particular type of brain cancer called glioblastoma in which the cancer recurred after a previous treatment.

Ixifi

• Biologic drug
• Pediatric indication

Decision Summary

• Medicinal Ingredient
  • Infliximab
• Indication
  • Ixifi is a medicine that is used in people with moderate to severe rheumatoid arthritis (in combination with methotrexate) and ankylosing spondylitis. Ixifi is also used in people with moderate to severe plaque psoriasis. Ixifi is also used in people with active psoriatic arthritis. Ixifi is also used in adults, children and teenagers with moderate to severe Crohn’s disease or with moderate to severe ulcerative colitis.

Nypozi

• Biologic drug
• Pediatric indication

Decision Summary

• Medicinal Ingredient
  • Filgrastim
• Indication
  • Nypozi is used to treat neutropenia, a condition where the body makes too few neutrophils. Neutropenia predisposes the body to infections and prevents it from fighting them. Nypozi is used to increase the number of neutrophils, which will fight infections. Neutropenia may be a long-standing condition where the body does not make enough neutrophils, or it may be caused by drugs used to treat cancer. In some cases, the body may make enough neutrophils, but as part of a patient’s treatment for cancer, their doctor may want to increase the number of certain blood cells (CD34 cells) and collect them. The cells are collected using a process called apheresis. These collected cells are given back to the patient after they receive very high doses of treatment for cancer to make their blood counts get back to normal more quickly. Nypozi is a man-made form of granulocyte colony-stimulating factor (G-CSF), which is made using the bacteria E coli. G-CSF is a substance naturally produced by the body.

Riabni

• Biologic drug
• Aligned review
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Rituximab
• Indication
  • Riabni (also known as rituximab) is a cancer medicine that is used to stop cancer cell growth and ideally cause the death of cancer cells. It is a cancer medicine that must be prescribed by a doctor. It is used to treat patients with certain types of non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. Riabni is an injectable medicine that is used to reduce signs and symptoms of rheumatoid arthritis (in combination with methotrexate). Riabni in combination with glucocorticoids or “steroids” is also used to reduce inflammation associated with severe Granulomatosis with Polyangiitis (GPA, also known as Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) and helps to control your disease.

Simlandi

• Biologic drug
• Orphan drug
• Pediatric indication

Decision Summary

• Medicinal Ingredient
  • Adalimumab
• Indication
  • Simlandi is a medicine that is used in:
    • Adults with rheumatoid arthritis, which is an inflammatory disease of the joints.
    • Adults with psoriatic arthritis, which is an inflammatory disease of the joints and skin.
    • Adults with ankylosing spondylitis, which is a form of arthritis.
    • Adults with Crohn’s disease, which is an inflammatory disease of the digestive tract.
    • Pediatrics with polyarticular juvenile idiopathic arthritis who are 2 years of age and older and require a full 40 mg dose based on body weight.
    • Adults with ulcerative colitis, which is an inflammatory disease of the bowel (colon).
    • Adults or adolescents (12 to 17 years of age, weighing ≥ 30 kg) with moderate to severe hidradenitis suppurativa (HS) who have not responded to antibiotics. HS is a painful, progressive, chronic inflammatory skin disease that causes nodules, abscesses, sinus tracts and fistulas under the breasts, underarms, buttocks and groin.
    • Adults with psoriasis, which is an inflammatory disease of the skin.
    • Adults with uveitis, which is an inflammatory disease of the eye.
    • Children (weighing ≥ 30 kg) with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye.

Yuflyma

• Biologic drug
• Pediatric indication

Decision Summary

• Medicinal Ingredient
  • Adalimumab
• Indication
  • Yuflyma (adalimumab injection) treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA) (weighing ≥ 30 kg), psoriatic arthritis (PsA), ankylosing spondylitis (AS), adult Crohn’s disease (CD), adult ulcerative colitis (UC), adult and adolescent (12 to 17 years of age weighing ≥ 30 kg) hidradenitis suppurativa (HS), psoriasis (Ps) or adult and pediatric uveitis (weighing ≥ 30 kg), and familiar with the Yuflyma efficacy and safety profile. Adalimumab injection has not been studied in pediatric patients with polyarticular JIA less than 2 years of age or in pediatric patients with a weight below 10 kg. There are no clinical trials with adalimumab injection in adolescent patients with hidradenitis suppurativa (HS). The dosage of Yuflyma in these patients has been determined based on pharmacokinetic/pharmacodynamic modeling and simulation. Adalimumab injection has not been studied in pediatric patients with uveitis less than 2 years of age. Very limited data are available for pediatric patients with uveitis between 2 and < 3 years of age. Evidence from clinical studies and experience suggests that use of adalimumab injection in the geriatric population is not associated with differences in effectiveness.

Zirabev

• Biologic drug
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Bevacizumab
• Indication
  • Metastatic Colorectal Cancer: Zirabev is used in combination with a specific type of chemotherapy (intravenous 5-fluorouracil [5-FU]-based chemotherapy) for treatment of people diagnosed with metastatic colorectal cancer for the first time. Metastatic colorectal cancer is cancer of the colon or rectum that has spread to other organs in the body.
  • Metastatic Lung Cancer: Zirabev is used in combination with a specific type of chemotherapy (carboplatin and paclitaxel) for the treatment of people diagnosed with metastatic non small cell lung cancer. Metastatic non small cell lung cancer is cancer of the lungs that has spread to other organs in the body.
  • Recurrent Platinum-Sensitive Ovarian Cancer: Zirabev is used in combination with a specific type of chemotherapy (carboplatin and gemcitabine) for the treatment of people.

48 new generic drugs

• 8 products containing dimethyl fumarate
• 11 products containing abiraterone
• 8 products containing lenalidomide
• 1 product containing methotrexate
• 1 product containing arsenic trioxide
• 5 products containing bendamustine hydrochloride
• 1 product containing busulfan
• 1 product containing cytarabine
• 5 products containing pirfenidone
• 1 product containing temozolomide
• 2 products containing mycophenolate mofetil
• 1 product containing mycophenolic acid
• 2 products containing pemetrexed
• 1 product containing dasatinib

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

• 1 product containing pentamidine isetionate

Blood and blood forming organs

For example, drugs such as anticoagulants.

4 new drugs

Glassia

• Biologic drug
• Orphan drug
• Medicinal Ingredients
  • Alpha1-Proteinase Inhibitor (Human) (A1-PI)
• Indication
  • Glassia is a liquid medicine containing human Alpha1-Proteinase Inhibitor (Alpha1-PI) also known as alpha1-antitrypsin (AAT), which is purified from human blood. The main purpose of infusing Glassia is to increase the levels of the AAT protein in your blood and lungs. AAT protein protects the lung tissue by blocking certain enzyme-caused damage. Limitations of Use: The effects of increasing the AAT protein levels with Glassia on worsening pulmonary function and progression of emphysema have not been proven in clinical trials. The long-term effects of AAT replacement and maintenance therapy with Glassia have not been studied. Glassia is not intended as a therapy in individuals with lung disease other than severe Alpha1 –PI deficiency.

Reblozyl

• Biologic drug
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Luspatercept
• Indication
  • Reblozyl is used to treat adults who have low red blood cell counts (anemia) and require red blood cell transfusions due to a blood disorder (β-thalassemia) that affects the production of hemoglobin (a protein in the red blood cells that transports oxygen throughout the body).

Triferic Avnu

• New active substance
• Medicinal Ingredient
  • Ferric pyrophosphate citrate
• Indication
  • Triferic Avnu is used to maintain iron levels in adults with chronic kidney disease who are undergoing hemodialysis.

Vistaseal

• Biologic drug
• Reviewed with international partner(s)

Decision Summary

• Medicinal Ingredients
  • Human fibrinogen (80 mg/mL) and human thrombin (500 IU/mL)
• Indication
  • Vistaseal is used as a sealant during surgical operations in adults. It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient.

6 new generic drugs

• 3 product containing ticagrelor
• 2 products containing bivalirudin
• 1 product containing treprostinil

Cardiovascular system

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

3 new drugs

Leqvio

• Aligned review
• New active substance
• Reviewed with international partner(s)
• Orphan drug
• Medicinal Ingredient
  • Inclisiran
• Indication
  • Leqvio is used in adults to further lower the LDL cholesterol levels. It is for patients who are currently taking a statin (a medicine used to treat high cholesterol. Leqvio is used in addition to lifestyle changes, including diet in patients who have: Heterozygous familial hypercholesterolemia (HeFH) (an inherited genetic disorder that causes extremely high cholesterol levels), or Non-familial hypercholesterolemia (a condition that affects the body processes cholesterol) with atherosclerotic cardiovascular disease (a hardening of the arteries). The effect of Leqvio on heart problems such as heart attacks, stroke or death is not known.

Opsynvi

• Orphan drug
• Medicinal Ingredient
  • Macitentan, tadalafil
• Indication
  • Opsynvi is used in adults to treat certain types of pulmonary arterial hypertension (PAH), which is high blood pressure in the blood vessels leading to the lungs. Opsynvi can be taken on its own, or with other PAH medications.

Vyndamax

• Orphan drug
• Medicinal Ingredient
  • Tafamidis
• Indication
  • Vyndamax is used to treat adults with cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). Cardiomyopathy is a disease of the heart muscle that makes it harder for the heart to pump blood to the rest of the body. Vyndamax reduces death and hospitalization related to heart problems. Vyndamax is not for use in patients less than 18 years of age.

17 new generic drugs

• 1 product containing dronedarone
• 1 product containing diltiazem hydrochloride
• 1 product containing furosemide
• 1 product containing hydralazine hydrochloride
• 1 product containing bisoprolol
• 1 product containing midodrine
• 1 product containing olmesartan
• 1 product containing quinapril
• 1 product containing spironolactone
• 1 product containing lidocaine hydrochloride
• 1 product containing milrinone lactate
• 1 product containing rosuvastatin
• 1 product containing amlodipine
• 1 product containing atorvastatin
• 1 product containing valsartan
• 2 products containing clonidine hydrochloride

Dermatologicals

For example, drugs to treat psoriasis.

2 new drugs

Adtralza

• Biologic drug
• New active substance
• Aligned review

Decision Summary

• Medicinal Ingredients
  • Tralokinumab
• Indication
  • Adtralza (tralokinumab injection) is indicated for the treatment of moderate-to-severe atopic dermatitis in adult patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Adtralza can be used with or without topical corticosteroids. It is not known if Adtralza is safe and effective in children under 18 years old.

Arazlo

• Pediatric indication

Decision Summary

• Medicinal Ingredients
  • Tazarotene
• Indication
  • Arazlo is used on the skin to treat people 10 years of age and older with acne vulgaris (acne). It is recommended that for children (10 to less than 12 years of age), Arazlo should be used on the face only.

3 new generic drugs

• 1 product containing ambrisentan
• 1 product containing acyclovir
• 1 product containing tretinoin

Genito urinary system and sex hormones

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

5 new drugs

Inprosub

• Orphan drug
• Medicinal Ingredient
  • Progesterone
• Indication
  • Inprosub is used in adult women who need extra progesterone while undergoing in vitro fertilization (IVF). These women must be 34 years of age or younger. As well, they will not be able to use or tolerate other products given through the vagina. Inprosub is intended to be used only by women who are able to get pregnant (of child-bearing age).

Nextstellis

• New active substance
• Medicinal Ingredient
  • Estetrol monohydrate, drospirenone
• Indication
  • Nextstellis is indicated to prevent pregnancy.

Osphena

• New active substance
• Medicinal Ingredient
  • Ospemifene
• Indication
  • Osphena is used in postmenopausal (after menopause) women to treat some symptoms of Genitourinary Syndrome of Menopause (GSM). Osphena is used to treat moderate to severe symptoms such as: pain during sex due to changes in and around the vagina; dryness due to changes in and around the vagina.

Slynd

• Medicinal Ingredient
  • Drospirenone
• Indication
  • Slynd is used to prevent pregnancy in girls and adult women aged 12 years and older who can become pregnant.

Vablys

Decision Summary

• Medicinal Ingredient
  • Dequalinium chloride
• Indication
  • Vablys is used to treat an infection of the vagina, called bacterial vaginosis. It is used in adult women who are younger than 55 years of age.

11 new generic drugs

• 3 products containing tadalafil
• 4 products containing silodosin
• 1 product containing etonogestrel, ethinyl estradiol
• 1 product containing darifenacin
• 1 product containing fesoterodine fumarate
• 1 product containing medroxyprogesterone

Musculo-skeletal system

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

2 new drugs

Evrysdi

• Priority review
• New active substance
• Orphan drug
• Pediatric indication
• Medicinal Ingredient
  • Risdiplam
• Indication
  • Evrysdi is a medicine used to treat spinal muscular atrophy (SMA), which is a condition that affects the nervous system. Evrysdi is for use in children 2 months of age and older and in adults.

Myinfla

• Priority review
• Aligned review
• Medicinal Ingredient
  • Colchicine
• Indication
  • Myinfla is used to reduce cardiovascular risks in patients with plaque build-up in the arteries, which narrows the arteries and restricts the blood supply to the heart.

5 new generic drugs

• 1 product containing alendronic acid, vitamin D3
• 2 products containing ketorolac tromethamine
• 1 product containing rocuronium bromide
• 1 product containing zoledronic acid

Nervous system

For example, analgesics and antidepressants.

3 new drugs

Sunosi

• New active substance
• Orphan drug
• Medicinal Ingredient
  • Solriamfetol (as solriamfetol hydrochloride)
• Indication
  • Sunosi helps you feel less sleepy during the day. It is used for adults with: narcolepsy – a condition that causes you to suddenly and unexpectedly feel very sleepy at any time, as well as Obstructive Sleep Apnea (OSA) – a condition where your breathing stops for brief periods of time when you sleep.

Vyepti

• Biologic drug
• New active substance

Decision Summary

• Medicinal Ingredient
  • Eptinezumab
• Indication
  • Vyepti is a medicine used to prevent migraine in adults who have at least 4 migraine days per month.

Wakix

• New active substance
• Orphan drug

Decision Summary

• Medicinal Ingredient
  • Pitolisant hydrochloride
• Indication
  • Wakix is used in adults with narcolepsy (a type of sleep disorder) to reduce: excessive sleepiness during the day; and cataplexy (sudden weak or paralyzed muscles).

14 new generic drugs

• 1 product containing acetaminophen
• 1 product containing betahistine hydrochloride
• 1 product containing bupivacaine hydrochloride
• 2 products containing buspirone hydrochloride
• 1 product containing dexmedetomidine hydrochloride
• 1 product containing pregabalin
• 1 product containing tramadol hydrochloride
• 1 product containing fluoxetine hydrochloride
• 1 product containing levodopa, carbidopa, entacapone
• 1 product containing paliperidone
• 1 product containing venlafaxine hydrochloride
• 1 product containing mixed salts amphetamine
• 1 product containing buprenorphine hydrochloride, naloxone hydrochloride dihydrate

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

• Aligned review

Decision Summary

• Medicinal Ingredients
  • Budesonide, glycopyrronium (as bromide), formoterol fumarate dihydrate
• Indication
  • Breztri Aerosphere is used in adults for the long-term treatment of a lung disease called chronic obstructive pulmonary disease (COPD), including chronic bronchitis and Emphysema.

Trikafta

• Priority review
• New active substance
• Aligned review
• Orphan drug
• Pediatric indication

Decision Summary

• Medicinal Ingredients
  • Elexacaftor, tezacaftor, ivacaftor
• Indication
  • Trikafta is used for the treatment of cystic fibrosis (CF) in patients 12 years of age and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. It is not known if Trikafta is safe and effective in children under 12 years of age.

3 new generic drugs

• 1 product containing cetirizine hydrochloride
• 1 product containing fluticasone propionate
• 1 product containing montelukast

Sensory organs

For example, drugs to treat vision loss.

2 new drugs

Cequa

Decision Summary

• Orphan drug
• Medicinal Ingredient
  • Cyclosporine
• Indication
  • Cequa is used to treat a condition called keratoconjunctivitis sicca also known as dry eye disease. Cequa makes your eyes produce more tears.

Tissueblue

• New active substance
• Orphan drug
• Medicinal Ingredient
  • Brilliant blue G
• Indication
  • TissueBlue is used as an aid in eye surgery. It is used to stain a part of your eye called the internal limiting membrane (ILM).

3 new generic drugs

• 1 product containing dorzolamide hydrochloride
• 1 product containing dorzolamide hydrochloride, timolol maleate
• 1 product containing olopatadine hydrochloride

Systemic hormonal preparations, excluding sex hormones and insulins

For example, drugs to treat hypothyroidism.

1 new drug

Ngenla

• New active substance
• Biologic drug
• Orphan drug
• Pediatric indication

Decision Summary

• Medicinal Ingredient
  • Somatrogon
• Indication
  • Ngenla is used for the long-term treatment of children who are not growing because of low growth hormone levels.

2 new generic drugs

• 1 product containing desmopressin acetate
• 1 product containing methylprednisolone

Various

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

3 new generic drugs

• 1 product containing sodium pyrophosphate, stannous fluoride, total tin
• 2 products containing naloxone hydrochloride dihydrate

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:

• Blood fluid and tissue management devices – for example, blood separation systems.
• Body tissue manipulation and reparation devices – for example, bone grafts and dermal dressings.
• Cardiovascular devices – for example, cardiovascular catheters and pacemakers.
• In vitro diagnostic medical devices – for example, instrument/analyser and viral infection disease in vitro devices.
• Neurological devices – for example, neurological stimulation devices.
• Plastic surgery and cosmetic devices – for example, breast implants.
• Various – applicable to medical devices generally.

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.

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

• Indication
  • EmboCube Embolization Gelatin is indicated for use in embolization of blood vessels to occlude blood flow for controlling bleeding or hemorrhaging. EmboCube Embolization Gelatin occludes vessels up to 5 mm. EmboCube Embolization Gelatin is intended to be used in adults.

Embotrap III Revascularization Device

• Indication
  • The EMBOTRAP III Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.

Body tissue manipulation and reparation devices

For example, bone grafts and dermal dressings.

3 new medical devices

LegoGraft

• Indication
  • LegoGraft is recommended for:
    • Augmentation or reconstructive treatment of the alveolar ridge.
    • Filling of periodontal defects.
    • Filling of defects after root resection, apicoectomy, and cystectomy.
    • Filling of extraction sockets to enhance preservation of the alveolar ridge.
    • Elevation of the maxillary sinus floor.
    • Filling of periodontal defects in conjunction with products intended to Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
    • Filling of peri-implant defects in conjunction with products intended for Guided bone Regeneration (GBR).

Gem 21S Growth-Factor Enhanced Matrix

• Indication
  • GEM 21S is intended for use as a grafting device in periodontal regenerative procedures and is indicated for:
    • Augmentation or reconstructive treatment of the alveolar ridge.
    • Filling of periodontal defects.
    • Filling of extraction sockets to enhance preservation of the alveolar ridge.
    • Elevation of the maxillary sinus floor.
    • Filling of bone defects in conjunction with Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
    • Filling of peri-implant defects in conjunction with products intended for GBR.
    • Gingival recession associated with periodontal disease.

Salvinoss Collagen Xenograft + Collagen Bone Graft Material

• Indication
  • SalvinOSS Collagen is indicated for:
    • Augmentation or reconstructive treatment of the alveolar ridge.
    • Filling of infrabony periodontal defects.
    • Filling of defects after root resection, apicoectomy and cystectomy.
    • Filling of extraction sockets to enhance preservation of the alveolar ridge.
    • Elevation of the maxillary sinus floor.
    • Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
    • Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).

Cardiovascular devices

For example, cardiovascular catheters and pacemakers.

23 new medical devices

Orsiro Sirolimus Eluting Coronary Stent System

• License with conditions
• Indication
  • Orsiro is indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation myocardial infarction or documented silent ischemia due to atherosclerotic lesions in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm and a lesion length of <= 36 mm.

Achieve Advance Mapping Catheter

• Indication
  • The Achieve Advance mapping catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart (i.e., recording or stimulation only). The Achieve Advance mapping catheter is designed to obtain electrograms in the atrial regions of the heart.

Sapphire II Pro Balloon Dilatation Catheter

• Indication
  • The Sapphire II PRO Balloon Dilatation Catheter (diameter 1.0-1.25mm configurations) is indicated for:
    • Balloon pre-dilatation of a stenotic portion of a coronary artery or bypass graft stenosis (>=70% stenosis) for the purpose of improving myocardial perfusion.
    • Balloon pre-dilatation of a stenotic portion of a peripheral artery, including renal, femoral, popliteal, infra-popliteal, tibial and peroneal arteries.
  • The Sapphire II PRO Balloon Dilatation Catheter (diameter 1.5-4.0mm configurations) is indicated for:
    • Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion.
    • Balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction.
    • Percutaneous transluminal angioplasty in the peripheral vasculature, including renal, femoral, popliteal, infra-popliteal, tibial and peroneal arteries.

Stealth 360 Peripheral Orbital Atherectomy System

• Indication
  • The Stealth 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

Heartstart Intrepid Monitor/Defibrillator

• Indication
  • The HeartStart Intrepid is intended for use in an EMS or hospital setting by qualified medical personnel trained in the operation of the device and qualified by certified training in basic life support or advanced life support.

Alto Abdominal Stent Graft System

• License with conditions
• Indication
  • The Alto Abdominal Stent Graft System is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device.

Soundbite Crossing System – Peripheral (14P)

• License with conditions
• Indication
  • The SoundBite Crossing System – Peripheral is indicated to facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions via atherectomy. The SoundBite Crossing System – Peripheral is contraindicated for use in the carotid arteries.

Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System

• Indication
  • The Pulsar-18 T3 self-expanding stent system is indicated to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions in the femoral and proximal popliteal arteries.

Omniwire Pressure Guide Wire

• Indication
  • The OmniWire pressure guide wire is indicated for use to measure pressure in blood vessels, including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. It can also be used to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels. Blood pressure measurements provide hemodynamic information for the diagnosis and treatment of blood vessel disease.

ZOLL AED 3 Aviation

• Indication
  • The ZOLL AED 3 Aviation system is indicated for use when a suspected cardiac arrest victim has an apparent lack of circulation as indicated by: unconsciousness; absence of breathing; absence of pulse and other signs of circulation.
  • The AED 3 system is indicated for adult and pediatric patients.

Triclip G4 System

• License with conditions
• Indication
  • The TriClip G4 System is intended for reconstruction of the insufficient tricuspid valve through tissue approximation. The TriClip device is indicated for patients with severe tricuspid regurgitation who are symptomatic despite medical therapy with valve anatomies that are conducive for transcatheter repair and who have been determined to be at high or greater estimated risk for tricuspid valve surgery by a heart team.

Comet II Pressure Guidewire

• Indication
  • The Comet II Pressure Guidewire is indicated to direct a catheter through a blood vessel and to measure physiological parameters in the coronary blood vessels.

Tornado Embolization Coils and Microcoils

• Indication
  • The Tornado Embolization Coils and Microcoils are intended for arterial and venous embolization in the peripheral vasculature.

Nester Embolization Coils and Microcoils

• Indication
  • The Nester Embolization Coils and Microcoils are intended for arterial and venous embolization in the peripheral vasculature.

Mynx Control Vascular Closure Device

• Indication
  • The Mynx Control Vascular Closure Device is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

Synergy Megatron Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System

• License with conditions
• Indication
  • The Synergy Megatron Everolimus-Eluting Platinum Chromium Coronary Stent System is indicated for improving luminal diameter in patients, including those at high risk for bleeding, with diabetes mellitus, with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries.

Mitris Resilia Mitral Valve

• Indication
  • The Mitris Resilia Mitral Valve Model 11400M is indicated for the replacement of native or prosthetic mitral valves. The Mitris Resilia Mitral Valve Model 11400M is intended for use as a heart valve replacement.

Reprocessed Diagnostic Ultrasound Catheter

• Indication
  • The Reprocessed AcuNav Diagnostic Ultrasound Catheter is intended for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The reprocessed device is not indicated for use with pediatric patients. The catheter is intended for imaging guidance only, not treatment deliver, during cardiac interventional percutaneous procedures.

Reprocessed Advisor HD Grid Sensor Enabled High Density Mapping Catheter

• Indication
  • The Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart (i.e., recording or stimulation only). This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.

Epic Plus/Epic Plus Supra Stented Porcine Tissue Valves

• Indication
  • The Epic Plus valve is indicated for patients requiring replacement of a diseased, damaged or malfunctioning native aortic and/or mitral heart valve. It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.
  • The Epic Plus Supra valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic heart valve. It may also be used as a replacement for a previously implanted aortic prosthetic heart valve.

Perclose Prostyle Suture-Mediated Closure and Repair System

• Indication
  • The Perclose ProStyle SMCR System is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures.

Renamic Neo

• Indication
  • Renamic Neo is a portable programmer and monitoring device with an integrated pacing system analyzer (PSA), which is used in the implantation and follow-up of BIOTRONIK implantable pacemakers, ICDs (implantable cardioverter-defibrillator) or implantable cardiac monitors. The device provides communication with implantable pacemakers, ICDs or implantable BIOTRONIK cardiac monitors (ICMs) during the implantation or a follow-up.

Conquest 40 PTA Dilatation Catheter

• Indication
  • Conquest 40 PTA Dilatation Catheter is recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

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

• Indication
  • The Mirasol PRT system is intended to reduce the pathogen load and inactivate residual white blood cells in donor platelet concentrates for transfusion. The system is intended for platelets (apheresis and buffy coat) treated and stored in 100% plasma.

Alinity m HCV (Confirmatory)

• Indication
  • The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.

Atellica IM HBc Total 2 (HBcT2) (donor screening for transplantation)

• Indication
  • The Atellica IM HBc Total 2 (HBcT2) assay is for in vitro diagnostic use in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus (HBV) in human serum or plasma using the Atellica IM Analyzer.

PK CMV-PA system

• Indication
  • The PK CMV-PA System is a passive particle agglutination assay intended for the qualitative detection of IgG and IgM antibodies to cytomegalovirus (CMV) in human EDTA plasma and serum from blood donors using the Beckman Coulter PK7300 and/or PK7400 Automated Microplate Systems.

Vitros Immunodiagnostic Products Anti-HTVL-I/II Reagent, Calibrator and Control

• Indication
  • For the in vitro qualitative detection of antibodies to human T-cell lymphotropic virus Types I and/or II, (HTLV-I and HTLV-II) in human serum and plasma (heparin, EDTA and citrate) in adults, using the automated Vitros ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems.

Neurological devices

For example, neurological stimulation devices.

11 new medical devices

Wavewriter Alpha Spinal Cord Stimulator System

• Indication
  • The Boston Scientific Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain.

Vercise Genus Deep Brain Stimulation System

• Indication
  • The Boston Scientific DBS System is indicated for use in:
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for levodopa‑responsive Parkinson’s disease that is not adequately controlled with medication.
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older.
    • Stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of tremor that is not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

eCLIPs System

• Indication
  • The eCLIPs System (eCLIPs Device, Micro-introducer, Microcatheter and Detacher) is intended to treat unruptured or stable, previously ruptured (>30 days) intracranial, saccular aneurysms arising at the Internal Carotid Artery (ICA) Bifurcation or the Basilar Artery Bifurcation.

Wavewriter Alpha Spinal Cord Stimulator System – Alpha 16

• Indication
  • The Boston Scientific Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain.

Wavewriter Alpha Spinal Cord Stimulator System – Alpha Prime

• Indication
  • The Boston Scientific Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain.

Wavewriter Alpha Spinal Cord Stimulator System – Alpha Prime 16

• Indication
  • The Boston Scientific Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractable pain.

Stereotactic TCD Electrodes

• Indication
  • The Cosman Disposable Stereotactic TC Electrode is indicated for use in RF heat lesioning of nervous tissue, including the Central Nervous System. Examples of RF procedures include thalamotomy and pallidotomy to treat movement disorders such as Parkinson’s disease, dystonia or essential tremor which are not adequately controlled by medication.

Vercise Genus P8 Deep Brain Stimulation System

• Indication
  • The Boston Scientific DBS System is indicated for use in the following:
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for levodopa‑responsive Parkinson’s disease that is not adequately controlled with medication.
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older.
    • Stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of tremor that is not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

Vercise Genus P32 Deep Brain Stimulation System

• Indication
  • The Boston Scientific DBS System is indicated for use in the following:
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for levodopa‑responsive Parkinson’s disease that is not adequately controlled with medication.
      Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older.
    • Stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of tremor that is not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

Vercise Genus R16 Deep Brain Stimulation System

• Indication
  • The Boston Scientific DBS System is indicated for use in the following:
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for levodopa‑responsive Parkinson’s disease that is not adequately controlled with medication.
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older.
    • Stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of tremor that is not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

Vercise Genus R32 Deep Brain Stimulation System

• Indication
  • The Boston Scientific DBS System is indicated for use in the following:
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for levodopa‑responsive Parkinson’s disease that is not adequately controlled with medication.
    • Unilateral or bilateral stimulation of the subthalamic nucleus (STN) or internal globus pallidus (GPi) for treatment of intractable primary and secondary dystonia, for persons 7 years of age and older.
    • Stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of tremor that is not adequately controlled by medications in patients diagnosed with Essential Tremor or Parkinson’s disease.

Plastic surgery and cosmetic devices

For example, breast implants.

1 new medical device

Nexus Ultrasonic Surgical Aspirator System

• Indication
  • The Misonix Inc neXus Ultrasonic Surgical Aspirator System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.

Various

Applicable to medical devices generally.

Safety update

Ultrasound gels and lotions:

• Dear Healthcare Professional Letter: Recall of EcoGel 200 Ultrasound Gel – MediChoice (M500812) – Contamination with Burkholderia stabilis [updated on August 19, 2021]
• Dear Healthcare Professional Letter: Important Safety Information on Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceuticals, Inc. – Potential Contamination with Burkholderia stabilis

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.

6 new drugs

NexGard Combo

• New active substance
• Medicinal Ingredients
  • Esafoxolaner, eprinomectin, praziquantel
• Indication
  • Topical solution for cats indicated for:
    • The treatment and control of flea infestations by killing adult fleas.
    • The treatment and control of Blacklegged Ticks and Lone Star Ticks.
    • The treatment of ear mites Otodectes cynotis.
    • The prevention of heartworm disease Dirofilaria immitis.
    • The treatment and control of intestinal cestode infections caused by the adult tapeworms.
    • The treatment and control of intestinal nematode infections caused by adult Toxocara cati (in cats and kittens 8 weeks of age and older).

Dormazolam

• New active substance
• Medicinal Ingredient
  • Midazolam
• Indication
  • For use with ketamine as an intravenous induction agent for the anaesthesia of healthy adult horses.

Solensia

• New active substance
• Medicinal Ingredient
  • Frunevetmab
• Indication
  • Solensia is indicated for the alleviation of pain associated with osteoarthritis in cats.

Draxxin KP

• Medicinal Ingredients
  • Tulathromycin, ketoprofen
• Indication
  • Indicated for the treatment of clinical bovine respiratory disease (BRD), with accompanying pyrexia, associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin in beef and non-lactating dairy cattle 2 months of age and older.

Solofer

• Medicinal Ingredient
  • Iron (iron dextran complex)
• Indication
  • Indicated for the treatment and prevention of iron deficiency anemia in newborn piglets.

Librela

• Medicinal Ingredient
  • Bedinvetmab
• Indication
  • Indicated for the alleviation of pain associated with osteoarthritis in dogs.

13 new generic drugs

• 1 product containing meloxicam
• 2 products containing tilmicosin
• 2 products containing tulathromycin
• 1 product containing amprolium hydrochloride
• 1 product containing imidacloprid, moxidectin
• 1 product containing amprolium
• 1 product containing apramycin sulfate
• 1 product containing ketoprofen
• 1 product containing acitracin methylene disalicylate
• 1 product containing altrenogest
• 1 product containing monensin sodium