Approved drugs and medical devices 2017

Select a health category to see the new drugs, medical devices with novel technology, generic drugs, and biosimilars approved for sale in Canada in 2017, and the risk communications issued.

Health categories:

• Anesthetics and surgery
• Antibiotics
• Arthritis
• Blood health (non-cancer)
• Cancer therapies
• Diabetic health
• Diagnostic agents
• Digestive and bladder health
• Extraordinary use
• Eye health
• The flu
• Genetic disorders
• Heart health
• Hormone therapies
• Immune system health
• Kidney disease
• Liver disease
• Mental health
• Neurological therapies
• Reproductive health
• Respiratory health
• Skin health
• Vaccines

Other risk communications issued

Six additional risk communications were issued in other categories, including three risk communications for medical devices, and one for bone health. The remaining two risk communications dealt with a product used in cases of poisoning, and a non-medicinal ingredient used in medications, such as tablets or capsules.

Product categories:

Within each health category, we have identified products using the following icons:

B:

Biologic drugs are biologically-derived products such as vaccines, blood-derived products, and products produced through biotechnology.

O:

Orphan drugs are used to treat rare diseases, and have received orphan designation in either the United States or the European Union.

C:

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. Submissions that are reviewed under this pathway are subject to shorter review targets.

P:

Priority review status may be granted to a drug submission or medical device application 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.

Important definitions:

New drugs

New drugs give you new and innovative options for treatment, prevention and diagnosis of various health conditions.

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.

Biosimilars

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.

Generic drugs

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 healthcare system.

Medical devices

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.

Novel technology

Medical devices with novel technology introduce a new apparatus, appliance, software or material with novel technology never before approved for sale in Canada.

Risk communications

Issued by Health Canada for a specific drug or medical device, or a group of related products, to inform healthcare professionals and the public of newly identified safety issues. Search recalls and safety alerts for more details.