I:docorrespsecretar ewdrugs_e.pdf

LISTING OF DRUGS CURRENTLY REGULATED AS NEW DRUGS
This list represents substances and formulations which have been assessed by the Therapeutic
Products Directorate on the basis of an application to market or further to promotion of
products for medicinal purposes where safety and efficacy for such purposes have not been
established.
This listing is not all-encompassing due in part to the complexity of Division 8 of the Food and
Drug Regulations. It should be used as a guide only in determining the status of subsequent
market entry drug products. This listing will be updated periodically.
“drug” includes any substance or mixture of substances manufactured, sold or represented for use
in
(a)
the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physicalstate, or its symptoms, in human beings or animals, restoring, correcting or modifying organic functions in human beings or animals, or disinfection in premises in which food is manufactured, prepared or kept; (Section 2 of the Food and Drugs Act ) “new drug” means
(a)
a drug that contains or consists of a substance, whether as an active or inactive ingredient,carrier, coating, excipient, menstruum or other component, that has not been sold as a drugin Canada for sufficient time and in sufficient quantity to establish in Canada the safety andeffectiveness of that substance for use as a drug; a drug that is a combination or two or more drugs, with or without other ingredients, and thathas not been sold in that combination or in the proportion in which those drugs are combinedin that drug, for sufficient time and sufficient quantity to establish in Canada the safety andeffectiveness of that combination and proportion for use as a drug; or a drug, with respect to which the manufacturer prescribes, recommends, proposes or claimsa use as a drug, or a condition of use as a drug, including dosage, route of administration, orduration of action and that has not been sold for that use or condition of use in Canada, forsufficient time and in sufficient quantity to establish in Canada the safety and effectiveness ofthat use or condition of use of that drug.
(Division 8 of the Food and Drugs Regulations) Please note: Unless otherwise indicated, all dosage forms and routes are included.
April 1999
Form/Route
* Bold indicates new additions to the list
AcarboseAcebutolol and its saltsAcetaminophen Acetaminophen / BelladonnaAcetaminophen / ButalbitalAcetaminophen / Butalbital / CaffeineAcetaminophen / Butalbital / Caffeine / Acetaminophen / Butalbital / CodeineAcetaminophen/Diphenhydramine (as a Acetylsalicylic Acid (Anti-platelet)Acetylsalicylic Acid/ Diphenhydramine (as Acitretin
Acyclovir and its salts
Adenosine and its salts1
Adapalene
Alatrofloxacin and its salts
Alclometasone and its salts
Alfentanil and its salts
Alkyl Salicylates
AllopurinolAlprazolamAlteplaseAltretamineAmantadine and its saltsAmcinonideAmikacin and its saltsAmiloride and its saltsAmino Acids [Tryptophan, Arginine, Ornithine, Phenylalanine, Tyrosine,
Lysine, Carnitine, Methionine
(other than Lipotropic Factor)]2
Form/Route
Aminocaproic AcidAminoglutethemideAminophylline suppository, oral modified releasepreparation Aminosalicylic Acid (5-)Amiodarone and its saltsAmitriptyline / PerphenzineAmlodipine and its salts and estersAmmonium Chloride (single active ingredient, except in homeopathicpreparations) Ammonium MolybdateAmodiaquineAmoxicillin and its saltsAmphotericin BAmrinone and its saltsAnagrelide and its saltsAnastrozoleApomorphine and its saltsApraclonidine and its saltsAprotoninArticaine and its saltsArticaine HCl/EpinephrineAsparaginaseAspartatesAstemizoleAtenolol and its saltsAtorvastatin and its saltsAtovaquoneAtracurium and its salts and estersAtropine and its salts Auranofin Azathioprine and its saltsAzelaic AcidAzithromycin and its saltsAztreonam and its saltsBaclofen and its saltsBambuterol and its saltsBeclomethasone and its salts Form/Route
Benazepril and its saltsBenzalkonium Chloride/Boric AcidBenzoyl Peroxide/ErythromycinBenzoyl Peroxide/Titanium Dioxide Benzydamine and its saltsBetahistine and its saltsBetaine Anhydrous (for the treatment of Betamethasone Dipropionate/ClotrimazoleBetamethasone/Gentamicin Betaxolol and its salts
Bezafibrate
Bicalutamide
Biperiden and its salts
Bismuth subcitrate(when used in
combination to eradicate H. Pylori)
Bisoprolol and its salts
Bleomycin and its salts
Boron
Bretylium Tosylate
Brimonidine and its salts
Brinzolamide
Bromazepam and its salts
Bromocriptine and its salts
Budesonide
Bumetanide and its salts
Bupivacaine and its salts
Buprenorphine and its salts
Bupropion and its salts
Buserelin and its salts
Buspirone and its salts
Butenafine and its salts
Butorphanol and its salts
Caffeine/Ephedrine
Calcipotriol
Calcitonin Salmon Synthetic
Calcitriol
Calcium Acetate (for the control of
Form/Route
Calcium Polystyrene Sulphonate
Candesartan Cilexetil
Capecitabine
Caprylic Acid3
Captopril and its salts
Carbamazapine
Carbetocin
Carbidopa and its salts
Carbocysteine
Carbon Monoxide/ Methane/ Nitrogen/
Carboplatin
Carboprost and its salts
Carvedilol
Cefaclor
Cefadroxil
Cefazolin and its salts
Cefdinir
Cefepime and its salts
Cefixime and its salts
Cefonicid and its salts
Cefotaxime and its salts
Cefotetan and its salts
Cefoxitin and its salts
Cefpodoxime and its salts
Cefprozil
Ceftazidime
Ceftibuten Dihydrate
Ceftizoxime and its salts
Cefuroxime
Centella4
Cephalexin (Monohydrate)
Cephalothin and its salts
Cerivastatin
Cetirizine and its salts
Chitosan
Chloramphenicol
Chlordiazepoxide / Clidinium and its salts Form/Route
Chlormezanone
Cholestyramine Resin
Choline Theophyllinate
Chondroitin and its salts3
Chromic Chloride
Chymopapain
Ciclopirox and its salts
Cilazapril and its salts
Cimetidine and its salts
Ciprofloxacin and its salts
Cisapride
Cisatracurium and its salts
Cisplatin
Citalopram and its salts
Cladribine
Clarithromycin
Clindamycin and its salts
Clobazam and its salts
Clobetasol and its salts
Clodronic Acid and its salts
Clofibrate
Clomiphene and its salts
Clomipramine and its salts
Clonazepam and its salts
Clonidine and its salts
Clopidogrel and its salts
Clorazepic Acid and its salts
Clotrimazole
Clozapine and its salts
Co-enzyme Q-10 (other than as source of
Co-TrimoxazoleCodeine Polistirex/Chlorpheniramine Colestipol and its saltsColfosceril PalmitateCoryceptin (Jing Ahi Dongchongxiacao)Cromolyn and its salts Form/Route
Cyclobenzaprine and its salts
Cyclosporine
Cyproterone and its salts
Cytarabine and its salts
Dacarbazine
Dalteparin and its salts
Danaparoid and its salts
Danazol and its salts
Dantrolene and its salts
Dapiprazole and its salts
Daunorubicin and its salts
Deferoxamine and its salts
Delavirdine and its salts
Deprenyl and its salts
Desflurane
Desipramine and its salts
Desmopressin and its salts
Desonide and its salts
Desoximetasone
Devil's Claw ( as anti-
inflammatory/analgesic or
as per THM Policy)Dexamethasone (in combination) Dexfenfluramine and its saltsDexrazoxaneDextran Dextrothyroxine and its saltsDiatrizoic Acid and its saltsDiazepamDibencozide (other than source of Vitamin Diclofenac and its saltsDidanosine and its salts and derivativesDiethylpropion and its saltsDiflucortolone and its saltsDiflunisal and its saltsDihydroepiandrosterone (DHEA) (Prasterone)5
Form/Route
Dimethylglycine (DMG)
Dimethyl Sulfoxide
Dinoprostone
Diphenidol and its salts
Diphenoxylate and its salts
Dipivefrin and its salts
Dipyridamole
Dirithromycin
Disopyramide and its salts
Divalproex and its salts
Dobutamine and its salts
Docetaxel
Docosahexanoic Acid (DHA)6
Dolasetron and its salts
Domperidone and its salts
Dong Quai (except as per the THM Policy)7
Dopamine and its salts
Doxacurium and its salts
Doxapram and its salts
Doxazosin and its salts
Doxepin and its salts
Doxorubicin and its salts
Doxycycline and its salts
Doxylamine Succinate (night time sleep
Droperidol and its saltsEchothiophate IodideEconazole and its saltsEdetic Acid and its salts Edoxudine
Edrophonium and its salts
Eicosapentaenoic Acid (EPA)6
Electrolytes (Total Parenteral Nutrition
Emedastine and its saltsEnalapril and its salts Enalaprilat and its saltsEnfluraneEnoxacin and its saltsEnoxaparin and its salts Form/Route
Epirubicin and its saltsEpoprostenol and its saltsErythromycin Erythromycin Ethylsuccinate/SulfisoxazoleEsmolol and its saltsEstazolamEstradiol and its saltsEstramustine and its saltsEstrogens / ProgestogensEthambutol and its saltsEthinyl EstradiolEtidronic Acid and its saltsEtidronate Disodium / Calcium CarbonateEtodolacEtoposide and its saltsEvening Primrose Oil (except as source for FamciclovirFamotidine and its saltsFat Emulsion (Total Parenteral Nutrition Felodipine and its salts
Fenfluramine and its salts
Fenofibrate
Fenoterol and its salts
Fentanyl and its salts
Fenticonazole
Ferulic Acid
Fexofenadine and its salts
Finasteride
Flecainide and its salts
Fleroxacin
Floctafenine
Fluconazole
Flucytosine
Fludarabine and its salts
Fludrocortisone and its salts
Flumazenil
Flumethasone / Iodochlorohydroxyquin
Form/Route
Flunarizine and its salts
Flunisolide and its salts
Fluocinolone and its salts
Fluoride and its salts
Fluoride and its salts (for osteoporosis,
otospongiosis and the treatment andprevention of gingivitis and plaque) Fluorometholone and its salts
Fluorouracil
Fluoxetine and its salts
Flupenthixol and its salts
Fluphenazine enanthate
Fluphenazine decanoate
Flurazepam and its salts
Flurbiprofen and its salts
Flutamide
Fluticasone and its salts
Fluvastatin and its salts
Fluvoxamine and its salts
Formestane
Formoterol and its salts
Foscarnet and its salts
Fosinopril and its salts
Fosphenytoin and its salts
Furosemide
Fusidic acid
Gabapentine
Gadodiamide
Gadolinium
Gadopentetate Dimeglumine
Gadoteridol
Galactose
Galactose/Palmitic Acid
Gallamine and its salts
Gallium Nitrate and its salts
Gamma Amino Butyric Acid (GABA)8
Gamma Hydroxybutyric Acid (GHB)9
Gamma Oryzanol
Ganciclovir and its salts
Gemcitabine and its salts
Gemfibrozil
Form/Route
Germanium
Gestonorone Caproate
Ginseng (except as per THM Policy)7
Ginseng/Guarana/Bee pollen
(except as per THM Policy)7
Glatiramer and its salts
Gliclazide
Glucomannan1
Glucosamine3
Glyburide
Glycopyrrolate
Gonadorelin and its salts
Goserelin and its salts
Gotu-Kola (see Centella)4
Granisetron and its salts
Grepafloxacin and its salts
Griseofulvin
HalcinonideHalobetasol and its saltsHalofantrine and its saltsHaloperidol and its saltsHaloproginHalothaneHeparin Hydrochlorothiazide (in combination)Hydrocodone modified release preparations, injection,immediate release spheroids Hydroxychloroquine SulfateHydroxycitric AcidHydroxyureaHyoscine Butylbromide Form/Route
IbandronateIbuprofen Idarubicin and its saltsImipramine and its salts Imiquimod
Indapamide Hemihydrate
Indinavir and its salts
Indomethacin
Iodixanol
Iodoquinol
Iohexol
Iopamidol
Iopentol
Iopromide
Iothalamate Meglumine
Iotrolan
Ioversol
Ipratropium and its salts
Irbesartan
Irinotecal and its salts
Iron Dextran
Isoflurane
Isoproterenol and its salts
Isosorbide DinitrateIsosorbide-5 MononitrateIsotretinoinIsradipineItraconazoleKava (except as homeopathic preparation and as per THM policy)7
Ketamine and its salts
Ketazolam
Ketoconazole
Ketoprofen and its salts
Ketorolac and its salts
Ketotifen and its salts
Khat (Kat, Chat - Catha Edulis, Cathenone)
Kojic Acid
Kola Nitida (except as per THM Policy)7
Labetalol and its salts
Lamotrigine
Form/Route
Lansoprazole
Latanoprost
Letrozole and its salts
Leucovorin and its salts
Leuprolide and its salts
Levamisole and its salts
Levobunolol and its salts
Levocabastine and its salts
Levocarnitine2
Levodopa and its salts
Levofloxacin
Levonorgestrel
Levorphanol
Lidocaine and its salts (antiarrhythmic
Lidocaine / PrilocaineLidocaine HCl / Dextrose 5% Lidocaine HCl/ Norepinephrine BitartrateLincomycin and its saltsLiothyronine and its saltsLisinopril and its saltsLithium and its saltsLodoxamide TromethamineLomefloxacin and its saltsLoperamide and its saltsLoracarbefLoratidineLoratidine / PseudoephedrineLorazepamLosartan and its saltsLovastatinLoxapine and its saltsMafenide and its saltsMagnesium PyrrolidoneMalathionMaprotiline and its saltsMebendazoleMeclofenamic Acid and its saltsMedroxyprogesterone AcetateMefenamic Acid and its salts Form/Route
Mefloquine and its saltsMegestrol and its saltsMelatoninMelatonin/Vitamin EMelphalan and its saltsMercaptopurineMeropenemMesalamineMesnaMetaproterenol and its saltsMetformin and its saltsMethadoneMethazolamideMethenamineMethenamine/Benzoic Acid/ Sodium MethimazoleMethotrexate and its saltsMethoxsalenMethyl Salicylate Metoclopramide and its saltsMetolazoneMetoprolol and its saltsMetrizamideMetronidazole and its salts Mexiletine and its salts
Miconazole and its salts
Midazolam and its salts
Midodrine and its salts
Miglitol
Milrinone and its salts
Minocycline and its salts
Minoxidil
Misoprostol
Mitomycin and its salts
Mitoxantrone and its salts
Mivacurium and its salts
Moclobemide
Form/Route
Mometasone Furoate
Montelukast and its salts
Morphine Sulphate
Mupirocin
Mycophenolate Mofetil
Nabumetone
Nadroparin and its salts
Nadolol and its salts
Nafarelin and its salts
Nafcillin and its salts
Naftifine and its salts
Nalbuphine and its salts
Nalidixic Acid
Nalmefene and its salts
Naloxone and its salts
Naltrexone and its salts
Nandrolone and its salts
Naproxen and its salts
Naratriptan and its salts
Nedocromil and its salts
Nelfinavir and its salts
Neomycin / Polymyxin B
Nevirapine
Nicardipine and its salts
Niclosamide
Nicotinamide (except as vitamin
NifedipineNilutamideNimodipineNitrazepamNitrofurantoin macrocrystalsNitroglycerin oral modified release, patch, ointment,injection, spray NizatidineNonoxynol-9 (HIV claim)NorfloxacinNortriptyline and its saltsNylidrin and its saltsNystatin/Zinc Oxide Form/Route
OctacosanolOctreotideOctyl Methoxycinnamate/Oxybenzone/ Ofloxacin
Olanzapine
Olopatadine and its salts
Olsalazine and its salts
Omega-3 Fatty Acids, EPA and DHA6
Omeprazole
Ondansetron and its salts
Oral Contraceptives
Orciprenaline and its salts
Oxacillin and its salts
Oxaprozin
Oxazepam
Oxiconazole and its salts
Oxybutynin and its salts
Oxycodone and its salts (as a single active
Oxymetholone
Paclitaxel
Pamidronic Acid and its salts
Pancuronium and its salts
Pangamic Acid and its salts1
Pantoprazole and its salts
Papain
Papaverine and its saltsParoxetine and its saltsPau D'Arco (Taheebo Tea) (except as per THM policy)7
Penciclovir
Penicillamine
Pentamidine and its salts
Pentastarch
Pentazocine and its salts
Pentosan Polysulfate Sodium
Pentostatin and its salts
Pentoxifylline and its salts
Peppermint Oil
Form/Route
PericyazinePerindopril and its saltsPermethrinPhentermine and its saltsPhenylbutazone Phenylephrine and its salts /Oxymetazoline PimozidePinaverium and its saltsPindolol and its saltsPiperacillin and its saltsPipotiazine and its saltsPirbuterol and its saltsPiroxicam and its saltsPlant SterolsPodofiloxPodophyllotoxinPolynicotinatesPorfimer and its saltsPotassium CitratePotassium Fluoride (except as oral mineral PramipexolePravastatin and its saltsPraziquantelPrazosin and its saltsPrednicarbatePrednisolone and its salts Prilocaine and its saltsProbucolProcainamide and its saltsProcarbazine and its saltsProcaterol and its saltsProchlorperizine Edisylate Form/Route
Propafenone and its saltsPropofolPropolis (for Herpes)Propoxyphene and its saltsPropranolol and its saltsPyrazinamidePyridostigmine Bromide tablet 30mg or any strength with nerve gasantidote claim, oral modified release tablet,injection PyrimethamineQuetiapine and its saltsQuinacrine and its saltsQuinapril and its saltsQuinidine BisulfateQuinidine Gluconate oral modified release preparation, injection Raloxifene and its salts
Raltitrexed and its salts
Ramipril and its salts
Ranitidine and its salts
Remifentanil and its salts
Retinoic Acid
Reviparin and its salts
Ribavirin
Rifabutin
Rifampin
Rifampin / Isoniazid / Pyrazinamide
Risperidone
Ritonavir and its salts
Rocuronium and its salts
Ropinirole and its salts
Ropivacaine and its salts
Salbutamol and its salts
Salcatonin
Salicylic Acid/Corticosteroids
Salsalate
Sanguinarine (as antiplaque agent)
Scopolamine HCl / Dihydroergotamine /
Barbital / Phenobarbital / Butalbital Sodium Form/Route
Selenious AcidSelenomethionineSermorelin and its saltsSertraline and its saltsSevofluraneSilicon (except as mineral supplement)Silver Nitrate Silver Sulfadiazine
Simvastatin and its salts
Sodium Nitroprusside
Sotalol and its salts
Spectinomycin
Spironolactone
Squalene
Stannous Fluoride (for gingivitis/plaque)
Stanozolol
Streptokinase
Sucralfate
Sufentanil and its salts
Sulbactam/Ampicillin
Sulfadoxine
Sulfamethoxazole/Trimethoprim
Sulfasalazine
Sulfinpyrazone
Sulindac
Sumatriptan and its salts
Superoxide Dismutase (SOD)
Tamoxifen and its salts
Tamsulosin and its salts
Tazarotene and its salts
Temazepam
Tenoxicam
Terazosine and its salts
Terbinafine and its salts
Terconazole
Terfenadine
Terlipressin and its salts
Testosterone and its salts
Form/Route
Thiabendazole
Tiaprofenic Acid and its salts
Ticarcillin and its salts
Ticlopidine and its salts
Tiludronate and its salts
Timolol and its salts
Tinzaparin and its salts
Tioconazole
Tixocortol Pivalate
Tizanidine and its salts
Tobramycin and its salts
Tolbutamide
Tolcapone
Tolmetin and its salts
Tolonium and its salts
Tolterodine l-tartrate
Topiramate
Topotecan and its salts
Toremiphene and its salts
Torsemide
Trace Elements (Total Parenteral Nutrition
Trandolapril and its saltsTranexamic AcidTranylcypromine SulfateTrazodone and its saltsTretinoin Triamterene TriazolamTrichloroacetic AcidTrichosanthinTriclosan Trifluoperazine / IsopropamideTrifluridineTriglycerides-Medium chain Trimebutine and its saltsTrimeprazine and its saltsTrimethoprim Trimetrexate GlucuronateTrimipramine and its salts Form/Route
Troglitazone and its salts
Trovafloxacin and its salts
Tryptophan (L-)2
Ursodiol
Valproic Acid and its salts
Valsartan
Vancomycin and its salts
Vecuronium and its salts
Venlafaxine and its salts
Verapamil and its salts
Vinblastine and its salts
Vincristine and its salts
Vinorelbine and its salts
Vitamins-Multi (with claim for Total
systemic embolism after myocardial infarction) Yohimbine (aphrodisiac)4
Zafirlukast
Zalcitabine and its salts
Zidovudine
Zinc Sulfate Heptahydrate
Zolmitriptan
Zolpidem and its salts
Zopiclone
Zuclopenthixol and its salts
In the absence of a therapeutic claim, this substance is not considered to be a drug. Thissubstance is only a new drug when intended as an active ingredient.
Amino acids present in a protein configuration are not considered to be drugs; only whenisolated and are present as single ingredient or in a configuration other than completed proteinis the drug/new drug status applicable. Note that L-tryptophan and L-Carnitine are onSchedule F to the Regulations, and thus, products containing these two substances would notbe considered to be subject to special measures as per the DIN Enforcement Directive andthe Therapeutic Products Compliance Guide.
This substance without therapeutic claims would not be considered a drug. It is only a newdrug when it is intended as a therapeutic agent.
Form/Route
This substance is listed on Schedule F and therefore, products containing this substance wouldnot be considered to be subject to special measures as per the Therapeutic ProductsCompliance Guide and the Interim DIN Enforcement Directive.
This substance is being regulated as a Schedule G (controlled) drug.
This substance, an omega-3 fatty acid, is present in fish oil and other food substances. It isto be regarded as a new drug only when intended as a therapeutic agent, whenisolated/concentrated and sold as a single ingredient or added to other ingredients. Note thatthis is not considered to be a product subject to special measures as per the TherapeuticProducts Compliance Guide and the Interim DIN Enforcement Directive since this is neithera traditional medicine, homeopathic medicine nor vitamin/mineral substance.
This substance without therapeutic claim is not considered to be a drug. Products containingthis substance with claim(s) would be considered to be subject to special measures unless itmeets one of the five criteria as per the DIN Enforcement Directive and the TherapeuticProducts Compliance Guide. If the claim(s) is not supported by traditional references as perthe Traditional Herbal Medicine Policy or only prescribed claims are supported, the productis considered to be a new drug.
This is a chemical and is not a substance of botanical origin. There is no known safe use ofthis substance. It is not acceptable as a non-medicinal ingredient at any level and is a newdrug when associated with therapeutic claim(s). Products containing this substance withtherapeutic claims would not be considered to be subject to special measures as per the DINEnforcement Directive and the Therapeutic Products Compliance Guide.
This substance is on Schedule III of the Controlled Drugs and Substances Act andRegulations.

Source: http://whatdoesthelawsay.ca/wp-content/uploads/2013/07/ndrugs_ndrogue-eng.pdf