How Safe and Innovative Are First-In-Class Drugs Approved by Health Canada: a Cohort Study
RESEARCH PAPER
How Safe and Innovative Are First-in-Class Drugs Approved by Health Canada: A Cohort Study
L’innocuité et l’aspect innovant des nouvelles classes de médicaments approuvés par Santé Canada : une étude de cohorte
JOEL LEXCHIN
Appendix 1. List of drugs with first-in-class and innovation status and Anatomical Therapeutic Chemical group
First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Abiraterone Ye s Ye s antineoplastic and immunomodulating agents
Abatacept Ye s No antineoplastic and immunomodulating agents
Abacavir No No anti-infective for systemic use
Acamprosate Ye s No nervous system
Adalimumab No No antineoplastic and immunomodulating agents
Adefovir No No anti-infective for systemic use
Agalsidase beta Ye s No alimentary tract and metabolism
Alatrofloxacin No No anti-infective for systemic use
Alefacept Ye s No antineoplastic and immunomodulating agents
Alemtuzumab Ye s Ye s antineoplastic and immunomodulating agents
Alfuzosin No No genito-urinary system and sex hormones
Alglucosidase alfa Ye s Ye s alimentary tract and metabolism
Aliskiren No No cardiovascular system
Alitretinoin No No antineoplastic and immunomodulating agents
Almotriptan No No nervous system
Ambrisentan No No cardiovascular system
Amprenavir No No anti-infective for systemic use
Anakinra Ye s No antineoplastic and immunomodulating agents
Anidulafungin No No anti-infective for systemic use
[1] HEALTHCARE POLICY Vol.12 No.2, 2016 Joel Lexchin
First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Aprepitant Ye s No alimentary tract and metabolism
Aripiprazole Ye s No nervous system
Atazanavir No No anti-infective for systemic use
Atomoxetine Ye s No nervous system
Atorvastatin No No cardiovascular system
Azacitidine Ye s Ye s antineoplastic and immunomodulating agents
Basiliximab No No antineoplastic and immunomodulating agents
Becaplermin Gel Ye s No dermatologicals
Belimumab Ye s No antineoplastic and immunomodulating agents
Besifloxacin No No sensory organs
Bevacizumab Ye s No antineoplastic and immunomodulating agents
Bimatoprost No No sensory organs
Bivalirudin No No blood and blood-forming agents
Bortezomib Ye s No antineoplastic and immunomodulating agents
Bosentan Ye s Ye s cardiovascular system
Botulinum toxin type B No No musculoskeletal system
Brimonidine No No sensory organs
Brinzolamide No No sensory organs
Cabazitaxel No No antineoplastic and immunomodulating agents
Cabergoline No No nervous system
Canakinumab No Ye s antineoplastic and immunomodulating agents
Candesartan No No cardiovascular system
Capecitabine No No antineoplastic and immunomodulating agents
Caspofungin Ye s Ye s anti-infective for systemic use
Celecoxib Ye s No musculoskeletal system
Cerivastatin No No cardiovascular system
Certolizumab pegol No No antineoplastic and immunomodulating agents
Cetrorelix No No systemic hormonal preparations, excluding sex hormones and insulins
Cetuximab Ye s No antineoplastic and immunomodulating agents
Ciclesonide No No respiratory system
Cidofovir No No anti-infective for systemic use
Cinacalcet Ye s Ye s systemic hormonal preparations, excluding sex hormones and insulins
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First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Citalopram No No nervous system
Clofarabine No Ye s antineoplastic and immunomodulating agents
Clopidogrel No No blood and blood-forming agents
Collagenase clostridium Ye s Ye s musculoskeletal system histolyticum
Crizotinib Ye s No antineoplastic and immunomodulating agents
Dabigatran No No blood and blood-forming agents
Daclizumab Ye s No antineoplastic and immunomodulating agents
Dalfopristin Ye s No anti-infective for systemic use
Daptomycin Ye s No anti-infective for systemic use
Darbepoetin alfa No No blood and blood-forming agents
Darifenacin No No genitourinary system and sex hormones
Darunavir No Ye s anti-infective for systemic use
Dasatinib No Ye s antineoplastic and immunomodulating agents
Deferasirox No No various
Degarelix No No antineoplastic and immunomodulating agents
Delavirdine No No anti-infective for systemic use
Denosumab Ye s No musculoskeletal system
Desloratadine No No respiratory system
Desvenlafaxine No No nervous system
Dexmedetomidine No No nervous system
Dienogest No No genitourinary system and sex hormones
Docosanol Ye s No dermatologicals
Dolasetron No No alimentary tract and metabolism
Donepezil No Ye s nervous system
Doripenem No No anti-infective for systemic use
Doxercalciferol No No systemic hormonal preparations, excluding sex hormones and insulins
Dronedarone No No cardiovascular system
Drospirenone No No genitourinary system and sex hormones
Drospirenone/ethinyl estradiol No No genitourinary system and sex hormones
Drotrecogin alfa Ye s Ye s blood and blood-forming agents
Duloxetine No No nervous system
Dutasteride No No genitourinary system and sex hormones
[3] HEALTHCARE POLICY Vol.12 No.2, 2016 Joel Lexchin
First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Eculizumab Ye s No antineoplastic and immunomodulating agents
Efalizumab Ye s No antineoplastic and immunomodulating agents
Efavirenz No Ye s anti-infective for systemic use
Eflornithine Ye s No dermatologicals
Eletriptan No No nervous system
Eltrombopag No No blood and blood-forming agents
Emedastine No No sensory organs
Emtricitabine No No anti-infective for systemic use
Enfuvirtide Ye s Ye s anti-infective for systemic use
Entacapone No No nervous system
Entecavir No No anti-infective for systemic use
Eplerenone No No cardiovascular system
Epoprostenol Ye s No blood and blood-forming agents
Eprosartan No No cardiovascular system
Eptifibatide No No blood and blood-forming agents
Eribulin Ye s No antineoplastic and immunomodulating agents
Erlotinib No No antineoplastic and immunomodulating agents
Ertapenem No No anti-infective for systemic use
Etanercept No Ye s antineoplastic and immunomodulating agents
Ethinyl estradiol/etonogestrel No No genitourinary system and sex hormones
Etravirine No No anti-infective for systemic use
Everolimus No No antineoplastic and immunomodulating agents
Exemestane No No antineoplastic and immunomodulating agents
Exenatide Ye s No alimentary tract and metabolism
Ezetimibe Ye s No cardiovascular system
Febuxostat No No musculoskeletal system
Fexofenadine No No respiratory system
Fingolimod Ye s No antineoplastic and immunomodulating agents
Fluticasone No No respiratory system
Fondaparinux Ye s No blood and blood-forming agents
Formoterol No No respiratory system
Fosaprepitant No No alimentary tract and metabolism
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First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Frovatriptan No No nervous system
Fulvestrant Ye s No antineoplastic and immunomodulating agents
Gadobenate No No not listed
Galantamine No No nervous system
Ganirelix Ye s No systemic hormonal preparations, excluding sex hormones and insulins
Gatifloxacin No No anti-infective for systemic use
Gefitinib Ye s No antineoplastic and immunomodulating agents
Gemifloxacin No No anti-infective for systemic use
Glatiramer Ye s No antineoplastic and immunomodulating agents
Glimepiride No No alimentary tract and metabolism
Golimumab No No antineoplastic and immunomodulating agents
Grepafloxacin No No anti-infective for systemic use
Histrelin No No antineoplastic and immunomodulating agents
Ibandronate No No musculoskeletal system
Ibritumomab Ye s No various
Icodextrin No No not listed
Idursulfase Ye s No alimentary tract and metabolism
Imatinib Ye s Ye s antineoplastic and immunomodulating agents
Imiglucerase No Ye s alimentary tract and metabolism
Indacaterol No No respiratory system
Infliximab Ye s Ye s antineoplastic and immunomodulating agents
Insulin detemir No No alimentary tract and metabolism
Insulin glulisine No No alimentary tract and metabolism
Interferon beta-1a No Ye s antineoplastic and immunomodulating agents
Ipilimumab Ye s No antineoplastic and immunomodulating agents
Irbesartan No No cardiovascular system
Irinotecan No Ye s antineoplastic and immunomodulating agents
Lacosamide No No nervous system
Lanreotide No Ye s systemic hormonal preparations, excluding sex hormones and insulins
Lanthanum No No various
Lapatinib No No antineoplastic and immunomodulating agents
Laronidase Ye s Ye s alimentary tract and metabolism
[5] HEALTHCARE POLICY Vol.12 No.2, 2016 Joel Lexchin
First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Latanoprost Ye s No sensory organs
Leflunomide Ye s No antineoplastic and immunomodulating agents
Lenalidomide No Ye s antineoplastic and immunomodulating agents
Letrozole No No antineoplastic and immunomodulating agents
Levetiracetam No No nervous system
Linagliptin No No alimentary tract and metabolism
Linezolid Ye s No anti-infective for systemic use
Liraglutide No No alimentary tract and metabolism
Lisdexamfetamine No No nervous system
Lopinavir/ritonavir No No anti-infective for systemic use
Loteprednol No No sensory organs
Lurasidone No No nervous system
Maraviroc Ye s No anti-infective for systemic use
Meloxicam No No musculoskeletal system
Memantine Ye s No nervous system
Mequinol/tretinoin No No dermatologicals
Methylnaltrexone Ye s Ye s alimentary tract and metabolism
Micafungin No No anti-infective for systemic use
Miglustat Ye s No alimentary tract and metabolism
Mirtazapine No No nervous system
Modafinil Ye s Ye s nervous system
Montelukast No No respiratory system
Moxifloxacin No No anti-infective for systemic use
Naratriptan No No nervous system
Natalizumab Ye s No antineoplastic and immunomodulating agents
Nateglinide No No alimentary tract and metabolism
Nebivolol No No cardiovascular system
Nelfinavir No No anti-infective for systemic use
Nepafenac No No sensory organs
Nesiritide Ye s No cardiovascular system
Nevirapine Ye s No anti-infective for systemic use
Nilotinib No No antineoplastic and immunomodulating agents
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First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Ofatumumab No No antineoplastic and immunomodulating agents
Olmesartan No No cardiovascular system
Omalizumab Ye s No respiratory system
Orlistat Ye s No alimentary tract and metabolism
Oseltamivir No No anti-infective for systemic use
Oxaliplatin No No antineoplastic and immunomodulating agents
Oxcarbazepine No No nervous system
Palifermin Ye s Ye s various
Paliperidone No No nervous system
Palivizumab Ye s No anti-infective for systemic use
Palonosetron No No alimentary tract and metabolism
Panitumumab No No antineoplastic and immunomodulating agents
Pantoprazole No No alimentary tract and metabolism
Paricalcitol No No systemic hormonal preparations, excluding sex hormones and insulins
Pazopanib No No antineoplastic and immunomodulating agents
Pegaptanib Ye s Ye s sensory organs
Pegfilgrastim No No antineoplastic and immunomodulating agents
Peginterferon alfa-2a No No antineoplastic and immunomodulating agents
Peginterferon alfa-2b No No antineoplastic and immunomodulating agents
Pegvisomant Ye s No systemic hormonal preparations, excluding sex hormones and insulins
Pemetrexed No Ye s antineoplastic and immunomodulating agents
Penciclovir No No anti-infective for systemic use
Perindopril No No cardiovascular system
Pimecrolimus No No dermatologicals
Pioglitazone No No alimentary tract and metabolism
Plerixafor Ye s No antineoplastic and immunomodulating agents
Posaconazole No Ye s anti-infective for systemic use
Pramipexole Ye s No nervous system
Prasugrel No No blood and blood-forming agents
Pregabalin No No nervous system
Quetiapine No No nervous system
Rabeprazole No No alimentary tract and metabolism
[7] HEALTHCARE POLICY Vol.12 No.2, 2016 Joel Lexchin
First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Raloxifene Ye s No genitourinary system and sex hormones
Raltegravir Ye s Ye s anti-infective for systemic use
Ranibizumab No Ye s sensory organs
Rasagiline No No nervous system
Rasburicase Ye s No various
Recombinant-methionyl No No antineoplastic and immunomodulating agents interferon consensus 1
Repaglinide Ye s No alimentary tract and metabolism
Rilpivirine No No anti-infective for systemic use
Riluzole Ye s Ye s nervous system
Risedronate No No musculoskeletal system
Rituximab Ye s Ye s antineoplastic and immunomodulating agents
Rivaroxaban No No blood and blood-forming agents
Rivastigmine No No nervous system
Rizatriptan No No nervous system
Rofecoxib No No musculoskeletal system
Roflumilast Ye s No respiratory system
Romiplostim Ye s No blood and blood-forming agents
Ropinirole No No nervous system
Rosiglitazone No No alimentary tract and metabolism
Rosuvastatin No No cardiovascular system
Rufinamide No No nervous system
Sapropterin Ye s Ye s alimentary tract and metabolism
Saxagliptin No No alimentary tract and metabolism
Sevelamer No No various
Sibutramine Ye s No alimentary tract and metabolism
Sildenafil Ye s Ye s genitourinary system and sex hormones
Silodosin No No genitourinary system and sex hormones
Sirolimus Ye s No antineoplastic and immunomodulating agents
Sitagliptin Ye s No alimentary tract and metabolism
Sodium oxybate No Ye s nervous system
Solifenacin No No genitourinary system and sex hormones
Sorafenib Ye s No antineoplastic and immunomodulating agents
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First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Sunitinib No Ye s antineoplastic and immunomodulating agents
Tadalafil No No genitourinary system and sex hormones
Tamsulosin No No genitourinary system and sex hormones
Tapentadol No No nervous system
Tegaserod Ye s No alimentary tract and metabolism
Telaprevir No Ye s anti-infective for systemic use
Telbivudine No No anti-infective for systemic use
Telithromycin Ye s No anti-infective for systemic use
Telmisartan No No cardiovascular system
Temozolomide No No antineoplastic and immunomodulating agents
Temsirolimus Ye s No antineoplastic and immunomodulating agents
Tenecteplase No No blood and blood-forming agents
Tenofovir No No anti-infective for systemic use
Ticagrelor No No blood and blood-forming agents
Tigecycline Ye s No anti-infective for systemic use
Tiotropium No No respiratory system
Tipranavir No No anti-infective for systemic use
Tirofiban No No blood and blood-forming agents
Tizanidine Ye s No musculoskeletal system
Tocilizumab Ye s No antineoplastic and immunomodulating agents
Tolcapone Ye s No nervous system
Tolterodine No No genitourinary system and sex hormones
Tolvaptan No No cardiovascular system
Topiramate No No nervous system
Topotecan Ye s No antineoplastic and immunomodulating agents
Tramadol No No nervous system
Trastuzumab Ye s No antineoplastic and immunomodulating agents
Travoprost No No sensory organs
Treprostinil No No blood and blood-forming agents
Triptorelin No No antineoplastic and immunomodulating agents
Trospium No No genitourinary system and sex hormones
Trovafloxacin No No anti-infective for systemic use
[9] HEALTHCARE POLICY Vol.12 No.2, 2016 Joel Lexchin
First-in-class Innovative Generic name (yes/no) (yes/no) Anatomical Therapeutic Chemical group (first level)
Ustekinumab Ye s No antineoplastic and immunomodulating agents
Valdecoxib No No musculoskeletal system
Valsartan No No cardiovascular system
Vandetanib No No antineoplastic and immunomodulating agents
Vardenafil No No genitourinary system and sex hormones
Varenicline Ye s No nervous system
Vemurafenib Ye s Ye s antineoplastic and immunomodulating agents
Verteporfin Ye s Ye s sensory organs
Voriconazole No No anti-infective for systemic use
Vorinostat Ye s No antineoplastic and immunomodulating agents
Zafirlukast Ye s No respiratory system
Zaleplon No No nervous system
Zanamivir Ye s No anti-infective for systemic use
Zoledronic acid No No musculoskeletal system
Zolmitriptan No No nervous system
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