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.
The Minor Tranquilizers, Including Xanax, Valium, BuSpar, Ativan, an. WARNING! When trying to withdraw from many psychiatric drugs, patients can develop serious and even life-threatening emotional and physical reactions. In short, it is dangerous not only to start taking psychiatric drugs but also can be hazardous to stop taking them. Therefore, withdrawal from psychiatric drugs
Aetna MedicareSM Plan (HMO) and Aetna MedicareSM Plan (PPO) Note: Medicare Advantage plan requirements govern and supersede any state or general disclosures contained within. Plan Benefi ts Member Cost Sharing Covered services include most types of treatment Cost sharing refers to the portion of medical provided by primary care physicians, specialists services that you pay out of