Prescription Drug List (PDL): Multiple Additions

December 20, 2013

Our file number: 13-119778-430

Notice

The purpose of this Notice of Amendment is to notify the addition of more than 120 drugs on the Prescription Drug List (PDL). With coming into force of the regulations to establish the PDL (Regulations Amending Certain Regulations Concerning Prescription Drugs (Repeal of Schedule F to the Food and Drug Regulations)) on December 19, 2013, Health Canada is now revising, effective immediately, the PDL. The drug and supporting qualifier in italics are the additions to the PDL.

The following drugs have been added to both the Human and Veterinary lists as single medicinal ingredients:

• Aflibercept
• Belimumab
• Brentuximab vedotin
• Canakinumab
• Catumaxomab
• Certolizumab pegol
• Clofarabine
• Denosumab
• Dimethylfumarate
• Dirlotapide
• Efinaconazole
• Enzalutamide
• Eplerenone
• Firocoxib
• Galsulfase
• Gamithromycin
• Ibafloxacin
• Idebenone
• Idursulfase
• Ipilimumab
• Ocriplasmin
• Ofatumumab
• Perampanel
• Pertuzumab
• Remestemcel-L
• Romidepsin
• Sevoflurane
• Spinosyn A and D isoforms
• Stiripentol
• Tocilizumab
• Trastuzumab emtansine
• Urokinase
• Velaglucerase Alfa
• Vismodegib
• Zucapsaicin

The following drugs have been added to both the Human and Veterinary lists as medicinal ingredients along with their salts (for example, Aclidinium or its salts or Colesevelam or its salts and Colesevelam hydrochloride will appear in the including (but not limited to) column):

• Aclidinium
• Afatinib
• Aripiprazole
• Besifloxacin
• Clevidipine
• Colesevelam including but not limited to Colesevelam hydrochloride
• Dabrafenib
• Desvenlafaxine including but not limited to Desvenlafaxine succinate
• Dolutegravir
• Eltrombopag including but not limited to Eltrombopag olamine
• Emamectin including but not limited to Emamectin benzoate
• Exenatide
• Fesoterodine including but not limited to Fesoterodine fumarate
• Glycopyrrolate including but not limited to Glycopyrronium bromide
• Imidapril
• Liraglutide
• Lurasidone
• Maropitant
• Mirabegron
• Nesiritide
• Olodaterol
• Palonosetron including but not limited to Palonosetron hydrochloride
• Pasireotide
• Pazopanib
• Plerixafor
• Prasugrel
• Prucalopride including but not limited to Prucalopride succinate
• Regorafenib
• Robenacoxib
• Ruxolitinib including but not limited to Ruxolitinib phosphate
• Sapropterin
• Saxagliptin
• Simeprevir
• Toceranib
• Tramadol
• Vilanterol including but not limited to Vilanterol trifenatate
• Zolmitriptan

The following drugs have been added to both the Human and Veterinary lists as medicinal ingredients along with their derivatives (for example, Abiraterone or its derivatives):

• Abiraterone
• Apixaban
• Boceprevir
• Fidaxomicin
• Ingenol mebutate
• Ivacaftor
• Lacosamide
• Macitentan
• Pirfenidone
• Riociguat
• Rufinamide
• Telaprevir
• Tepoxalin
• Ticagrelor
• Tolvaptan
• Trametinib including but not limited to Trametinib dimethylsulfoxide

The following drugs have been added to both the Human and Veterinary lists as medicinal ingredients along with their salts or derivatives (for example, Alitretinoin or its salts or derivatives):

• Alitretinoin
• Alogliptin
• Asenapine including but not limited to Asenapine maleate
• Axitinib
• Azacitidine
• Azilsartan medoxomil
• Bendamustine including but not limited to Bendamustine hydrochloride
• Crizotinib
• Degarelix
• Eribulin including but not limited to Eribulin mesylate
• Ezogabine
• Fampridine
• Febuxostat
• Fingolimod including but not limited to Fingolimod hydrochloride
• Guanfacine
• Indacaterol
• Linaclotide
• Leflunomide including but not limited to Teriflunomide
• Linagliptin
• Moclobemide
• Nebivolol
• Rifaximin
• Rilpivirine including but not limited to Rilpivirine hydrochoride
• Roflumilast
• Rotigotine
• Silodosin
• Toltrazuril including but not limited to Ponazuril
• Trabectedin
• Triptorelin
• Ulipristal including but not limited to Ulipristal acetate
• Vandetanib
• Vemurafenib

The following drugs have been added to only the Human list:

• Avermectin or its derivatives including but not limited to Ivermectin, Selamectin, Doramectin
• Difluprednate as an andrenocortical hormone derivative
• Doxycycline monohydrate as a salt of doxycycline
• Tulathromycin as a derivative of erythromycin
• Permethrin or its derivatives
• Phenylpropanolamine or its salts or derivatives
• Podophyllotoxin when recommended for topical use

The following drugs have been added to only the Veterinary list:

• Avermectin or its derivatives, including but not limited to Ivermectin, Selamectin, Doramectin, with the qualifier Ivermectin when recommended for intramuscular injection for horses, or for oral administration to dogs and cats; except doramectin
• Azithromycin or its salts or derivatives
• Desoxycorticosterone pivalate
• Difluprednate
• Doxycycline or its salts or derivatives, including but not limited to Doxycycline hyclate, Doxycycline monohydrate, when recommended for intramuscular injection for caged birds or for subgingival administration to dogs
• Gonadotropin releasing factors or their analogues
• Hydrocortisone aceponate
• Hyoscine butylbromide when recommended for parenteral use
• Mebendazole when sold to treat dogs only
• Permethrin or its derivatives when recommended for use in cats
• Polysulfated glycosaminoglycan
• Progesterone or its derivatives, except when recommended for use in Progesterone implants indicated for growth promotion, or when recommended for use as Melengestrol acetate in feed for the suppression of estrus in beef heifers
• Tulathromycin

The following drugs are added to both lists with a qualifier:

• Acetaminophen when recommended for administration by intravenous injection
• Collagenase when recommended for the debridement of severe burns and skin ulcers
• Hydroxocobalamin or its salts when recommended as an antidote for cyanide poisoning
• Immunogenic substances including but not limited to Dactylis glomerata L. (cocksfoot), Anthoxanthium odoratum L. (sweet vernal grass), Lolium perenne L. (rye grass), Poa pratense L. (meadow grass), Phleum pratense L. (timothy grass)  when recommended for sublingual use
• Potassium Citrate when recommended for the treatment of renal tubular acidosis and kidney stones

The following drugs were previously captured under a general heading on both lists but are being added to the including (but not limited to) column:

• Alprostadil, Travoprost as derivatives of prostaglandins
• Benazepril hydrochloride as a salt of benazepril
• Candesartan cilexetil as a derivative of candesartan
• Cefuroxime, Ceftazidine as derivatives of Cephalosporin C
• Divalproex sodium as a salt of Valproic acid
• Dronedarone as a derivative of amiodarone
• Ferumoxytol as an iron derivative
• Fosaprepitant as a derivative of aprepitant
• Levofloxacin as a derivative of Ofloxacin
• Levothyroxine sodium as a salt of thyroxin
• Mesalazine as a derivative of 5-Aminosalicyclic Acid
• Netilmicin as a derivative of gentamicin

Rationale:

A scientific review of these drugs against the former factors for listing drugs in Schedule F indicates they meet one or more of these factors and should only be available through a prescription.

While the drugs contained in this Notice were assessed against the factors for listing on Schedule F, future amendments to the PDL will be based on the criteria set out in C.01.040.3 of the Food and Drug Regulations. These criteria encompass and will now replace the Schedule F factors, which Health Canada has used for the past 20 years, when making decisions regarding prescription status. Additional information on how Health Canada now determines prescription

status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.

Should you have any questions on these amendments to the Prescription Drug List please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario K1A 0K9

Telephone: 613-957-1058
Facsimile: 613-941-5035
E-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.c