New Drugs Approved by Health Canada in 2018

This is a running list of the new drugs that received a Notice of Compliance from Health Canada in 2018. We will
continue to update this list throughout the year. The first section lists new molecular entities as they are approved
in 2018...and the second and third sections list significant new biologicals and significant new dosage forms of
previously approved drugs. Some of these drugs are not yet commercially available. You’ll also find a list of
important drug withdrawals of 2018. Descriptions and advice about using the most significant products appear in
the monthly issues of Pharmacist’s Letter, Pharmacy Technician’s Letter, and Prescriber’s Letter...and more
information can be found in our Clinical Resources. Subscribers can get the Clinical Resources from
PharmacistsLetter.com, PharmacyTechniciansLetter.com, and PrescribersLetter.com.

New Molecular Entities

BRAND GENERIC COMPANY DESCRIPTION
Addyi flibanserin Sprout (U.S.)/ A serotonin agonist/antagonist for premenopausal women with hypoactive
Therapeutic Products sexual desire disorder.
Aimovig erenumab Novartis A calcitonin gene-related peptide receptor antagonist for migraine
prevention.
Alunbrig brigatinib Takeda A kinase inhibitor for a certain type of non-small cell lung cancer.
Biktarvy bictegravir/ Gilead Sciences A combination drug for HIV-1 infection.
emtricitabine/
tenofovir alafenamide
Erleada apalutamide Janssen An androgen receptor inhibitor for non-metastatic, castration-resistant
prostate cancer.
Eucrisa crisaborole Pfizer A topical PDE-4 inhibitor for mild/moderate atopic dermatitis.
Kisqali ribociclib Novartis A kinase inhibitor for postmenopausal women with advanced breast cancer.
Lonsurf trifluridine/tipiracil Taiho Pharma New oral combination formulation for metastatic colorectal cancer.
Mar-Cidofovir cidofovir Marcan An IV antiviral for CMV retinitis in adults with AIDS.
Olumiant baricitinib Lilly An oral Janus kinase inhibitor for rheumatoid arthritis.
Ozempic semaglutide Novo Nordisk A GLP-1 agonist for type 2 diabetes.
Panhematin hemin Recordati Rare An IV porphyrin synthesis inhibitor for recurrent attacks of acute
Diseases intermittent porphyria related to the menstrual cycle.
Penthrox methoxyflurane Purdue Pharma A self-administered inhaled anesthetic/analgesic for short-term relief of
moderate to severe acute pain.
Steglatro ertugliflozin Merck An SGLT2 inhibitor for type 2 diabetes.
Symdeko ivacaftor/tezacaftor Vertex A combination formulation for cystic fibrosis.
Velphoro sucroferric Vifor Fresenius/ A chewable, calcium-free phosphate binder.
oxyhydroxide Innomar Strategies

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 Significant New Biologicals
BRAND GENERIC COMPANY DESCRIPTION
Afluria Tetra influenza vaccine Seqirus Quadrivalent influenza vaccine for preventing influenza.
Alphanate antihemophilic/von Grifols Canada For prevention and treatment of bleeding in von Willebrand disease.
Willebrand factor
Besponsa inotuzumab Pfizer A CD22-directed antibody-drug conjugate for advanced B-cell precursor
ozogamicin acute lymphoblastic leukemia.
Cutaquig immunoglobulin G Octapharma Human immunoglobulin given by SC infusion for primary or secondary
immune deficiency.
Fasenra benralizumab Astra Zeneca A monoclonal antibody for add-on maintenance treatment of severe
eosinophilic asthma.
Hadlima adalimumab Samsung Bioepis/ First biosimilar to Humira.
Merck
Hemlibra emicizumab Hoffmann-La Roche Treatment to reduce the frequency of bleeding episodes in hemophilia A.
Kymriah tisagenlecleucel Novartis T-cell immunotherapy for B-cell acute lymphoblastic leukemia or B-cell
lymphoma.
Lapelga pegfilgrastim Apotex First biosimilar to Neulasta.
Mvasi bevacizumab Amgen A biosimilar to Avastin, for colorectal & non-small cell lung cancer.
Nuceiva prabotulinumtoxinA Evolus (U.S.) A neuromuscular blocking agent for temporarily improving forehead
frown lines.
Rekovelle follitropin delta Ferring A recombinant human FSH for ovarian stimulation.
Siliq brodalumab Valeant An IL-17RA blocker for moderate to severe plaque psoriasis.

Significant New Dosage Forms

BRAND GENERIC COMPANY DESCRIPTION
Arbesda fluticasone/ Teva A steroid/LABA combination oral inhaler for asthma.
salmeterol
Bevespi glycopyrronium/ AstraZeneca New LAMA/LABA combination inhaler for COPD.
Aerosphere formoterol
Contrave naltrexone/ Valeant A combination opioid antagonist and antidepressant for weight
bupropion management.
Fucibet betamethasone/ Leo Pharma An antibiotic/steroid topical cream for eczema.
fusidic acid
Juluca rilpivirine/ ViiV Healthcare New combination formulation for HIV-1 infection.
dolutegravir
Mezera mesalazine Avir Pharma A rectal foam enema for ulcerative colitis and rectal suppository for
ulcerative proctitis.
Monoferric iron isomaltoside Pharmacosmos/ IV iron for iron deficiency anemia in adults.
1000 Pfizer
Probuphine buprenorphine Knight Therapeutics A partial opioid agonist subdermal implant for management of opioid
dependence.
Rayaldee calcifediol Vifor Fresenius/ A vitamin D3 analogue for secondary hyperparathyroidism in patients
Innomar Strategies with chronic kidney disease.
Segluromet ertugliflozin/ Merck An SGLT2 inhibitor/biguanide combo for use in type 2 diabetes.
metformin
Soliqua insulin glargine/ Sanofi-Aventis An insulin/GLP-1 agonist combination for type 2 diabetes.
lixisenatide
Steglujan ertugliflozin/ Merck An SGLT2 inhibitor/DPP-4 inhibitor combination for type 2 diabetes.
sitagliptin
Symtuza darunavir/cobicistat/ Janssen New combination regimen for HIV-1 infection.
emtricitabine/
tenofovir alafenamide
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 Significant New Dosage Forms, continued
BRAND GENERIC COMPANY DESCRIPTION
Trelegy Ellipta fluticasone furoate/ GSK A new combination oral inhaler for COPD.
umeclidinium/
vilanterol
Xultophy insulin degludec/ Novo Nordisk A combination long-acting insulin and GLP-1 agonist for type 2 diabetes.
liraglutide

Important Drug Withdrawals

BRAND GENERIC COMPANY DESCRIPTION
Zinbryta daclizumab Biogen Voluntary withdrawal due to safety concerns, including reports of severe
liver damage and immune-related conditions.

Copyright  2018 by Therapeutic Research Center

TEL (209) 472-2240 ~ FAX (209) 472-2249
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