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CADTH Common Drug Review (CDR) Reports

Brand Name Generic Name Indication Project Status Date Submission Received Date Recommendation Issued
Gynazole.1 Butoconazole nitrate Vaginal infection Complete June 30, 2004 January 26, 2005
NovoMix 30 Insulin aspart/insulin aspart protamine Diabetes mellitus Complete October 13, 2005 April 26, 2006
Fosavance 70/5600 Alendronate sodium / cholecalciferol Osteoporosis Complete December 18, 2008 June 17, 2009
Abilify Aripiprazole Depression, Major Depressive Disorder (MDD) Complete October 1, 2013 October 22, 2014
Abilify Maintena Aripiprazole Schizophrenia Active January 6, 2014 December 19, 2014
Abilify Aripiprazole Schizophrenia Complete November 6, 2009 April 27, 2010
Abilify Aripiprazole Schizophrenia and Related Psychotic Disorders Complete March 29, 2011 July 18, 2011
Abstral Fentanyl citrate Pain, Cancer (breakthrough) Complete June 30, 2011 December 16, 2011
Aclasta Zoledronic acid Osteoporosis (postmenopausal women) Complete July 20, 2011 November 16, 2011
Aclasta Zoledronic acid Osteoporosis, postmenopausal women Complete November 29, 2007 June 25, 2008
Actemra Tocilizumab Arthritis, Rheumatoid Complete March 3, 2014 February 19, 2015
Actemra Tocilizumab Arthritis, juvenile idiopathic Complete January 30, 2012 July 19, 2012
Actemra Tocilizumab Arthritis, Rheumatoid Complete May 27, 2010 November 17, 2010
Actemra Tocilizumab Polyarticular juvenile idiopathic arthritis Complete July 29, 2013 March 19, 2014
Actikerall Fluorouracil and Salicylic Acid Hyperkeratotic actinic keratosis Active August 31, 2016
Adcirca Tadalafil Pulmonary arterial hypertension Complete February 5, 2010 July 15, 2010
Adderall XR Mixed amphetamine salts Attention deficit hyperactivity disorder, Adult Complete November 29, 2007 June 25, 2008
Adderall XR Mixed amphetamine salts Attention deficit hyperactivity disorder Complete April 13, 2004 November 24, 2004
Adderall XR Mixed amphetamine salts Attention deficit hyperactivity disorder Withdrawn December 15, 2004
Adempas Riociguat Pulmonary hypertension, chronic thromboembolic Complete September 30, 2013 July 17, 2014
Adempas Riociguat Pulmonary arterial hypertension (WHO group 1) Active June 25, 2015 December 17, 2015
Advicor Niacin/lovastatin Hypercholesterolemia and mixed dyslipidemia Complete October 18, 2005 April 26, 2006
Zenhale (inhalation aerosol) Mometasone furoate and formoterol Asthma maintenance (adults, children 12 or older) Complete February 16, 2011 September 28, 2011
Afinitor Everolimus Subependymal giant cell astrocytoma associated with tuberous sclerosis complex Active March 19, 2014 April 15, 2015
Afinitor Everolimus renal angiomyolipoma associated with tuberous sclerosis complex (TSC) Complete March 8, 2013 September 25, 2013
Aldurazyme Laronidase Mucopolysarccharidosis 1 (MPS 1), Hurler, Hurler-Scheie, Scheie Complete February 3, 2005 July 14, 2005
Aloxi (capsule) Palonosetron Nausea and vomiting (chemotherapy induced) prevention Withdrawn February 6, 2015
Aloxi (injection) Palonosetron hydrochloride Nausea and vomiting (chemotherapy induced) prevention Complete October 5, 2012 May 15, 2013
Aloxi (capsule) Palonosetron hydrochloride Nausea and vomiting (chemotherapy induced) prevention Complete October 5, 2012 April 24, 2013
Altace Plus Felodipine Ramipril/felodipine extended release Hypertension Complete June 22, 2006 November 15, 2006
Altace HCT Ramipril/hydrochlorothiazide Hypertension Suspended October 26, 2006
Altace HCT Ramipril/hydrochlorothiazide Hypertension Complete March 26, 2007 June 14, 2007
Alvesco Ciclesonide asthma Complete July 24, 2006 December 20, 2006
Amevive Alefacept Psoriasis, moderate to severe chronic plaque Complete February 28, 2006 September 27, 2006
Amevive Alefacept Psoriasis, moderate to severe chronic plaque Complete November 16, 2004 May 26, 2005
Anoro Ellipta Umeclidinium/vilanterol Chronic Obstructive Pulmonary Disease Active February 26, 2014 January 15, 2015
Apidra Insulin glulisine Diabetes, Mellitus (Type 1 & 2) Complete August 29, 2008 February 19, 2009
Apprilon Doxycycline monohydrate Rosacea treatment Complete April 27, 2012 March 27, 2013
Aptiom Eslicarbazepine acetate Epilepsy, partial-onset seizures Complete August 15, 2014 April 16, 2015
Aptivus Tipranavir HIV infection Complete December 15, 2005 May 17, 2006
Arnuity Ellipta Fluticasone furoate Asthma Active June 26, 2015 December 17, 2015
ASMANEX Mometasone furoate Asthma, (Bronchial) Prophylactic management of steroid responsive Complete November 10, 2011 May 16, 2012
Atripla Efavirenz, emtricitabine, tenofovir disoproxil fumarate HIV Complete October 30, 2007 April 17, 2008
Aubagio Teriflunomide Multiple Sclerosis, relapsing Complete August 28, 2013 June 18, 2014
Somatuline Autogel Lanreotide acetate Acromegaly Complete February 20, 2007 July 19, 2007
Avodart Dutasteride Prostatic hyperplasia, benign Complete August 24, 2004 January 20, 2005
Axert Almotriptan Migraine Complete December 24, 2003 May 27, 2004
Azarga Brinzolamide and timolol maleate suspension Glaucoma and ocular hypertension Complete August 28, 2009 February 18, 2010
Azilect Rasagiline mesylate Parkinson’s disease Complete March 10, 2009
Azilect Rasagiline mesylate Parkinson's disease Complete September 1, 2006 March 28, 2007
Banzel Rufinamide Lennox-Gastaut syndrome; adjunctive treatment of seizures Complete September 20, 2011 March 15, 2012
Baraclude Entecavir Hepatitis B (chronic) Complete December 12, 2006 November 28, 2007
Basaglar Insulin glargine Diabetes mellitus, Type 1 & 2 Complete October 5, 2015 April 14, 2016
Benlysta Belimumab Systemic lupus erythematosus Complete September 19, 2011 April 25, 2012
Inflectra (Subsequent Entry Biologic) Infliximab Crohn’s disease and Ulcerative Colitis Active April 12, 2016 October 25, 2016
Botox OnabotulinumtoxinA Urinary incontinence Complete November 25, 2013 November 12, 2014
Botox OnabotulinumtoxinA Neurogenic Detrusor Overactivity Complete January 31, 2012 July 19, 2012
Botox OnabotulinumtoxinA Migraine, chronic Complete August 15, 2013 May 28, 2014
Ultibro Breezhaler Indacaterol/glycopyrronium COPD Active February 3, 2014 December 19, 2014
Brenzys Etanercept Rheumatoid arthritis, ankylosing spondylitis Active April 20, 2016 October 25, 2016
Breo Ellipta Fluticasone furoate /vilanterol Chronic Obstructive Pulmonary Disease (COPD) Active October 29, 2013 August 18, 2014
Breo Ellipta Fluticasone Furoate and Vilanterol (as trifenatate) Asthma Active August 10, 2015 February 18, 2016
Brilinta Ticagrelor Acute Coronary Syndromes (ACS) Cancelled June 8, 2010
Brilinta Ticagrelor Thrombotic events in Acute Coronary Syndromes, Prevention Complete June 1, 2011 December 16, 2011
Brilinta ticagrelor Prevention of atherothrombotic events with history of myocardial infarction Active February 18, 2016 August 25, 2016
Brivlera Brivaracetam Epilepsy, partial-onset seizures Active April 19, 2016
BuTrans Buprenorphine transdermal patch Pain, persistent (moderate intensity) Cancelled October 15, 2010
BuTrans Buprenorphine transdermal patch Pain, persistent (moderate intensity) Complete May 9, 2011 September 28, 2011
Byetta Exenatide Diabetes mellitus, Type 2 Complete August 23, 2011 July 19, 2012
Bystolic Nebivolol Hypertension, essential Complete February 4, 2013 July 18, 2013
Caduet Amlodipine besylate/ atorvastatin calcium Hypertension/ Dyslipidemia Complete December 15, 2005 May 17, 2006
Campral Acamprosate calcium Alcohol Abstinence Complete July 22, 2008
Campral Acamprosate calcium Alcohol Abstinence Complete August 29, 2007 March 27, 2008
Cayston Aztreonam for inhalation solution Cystic fibrosis (CF) with chronic pulmonary pseudomonas aeruginosa infections Complete December 2, 2010 July 18, 2011
Celsentri Maraviroc HIV-1, treatment naïve (adult) Complete December 8, 2010 July 18, 2011
Celsentri Maraviroc HIV Withdrawn November 2, 2007
Celsentri Maraviroc HIV Complete May 7, 2008 November 12, 2008
Cerdelga Eliglustat Gaucher disease Pending January 20, 2017
Champix Varenicline tartrate Smoking-cessation Complete March 21, 2007 August 16, 2007
Cimzia Certolizumab pegol Ankylosing spondylitis Active June 23, 2014 April 17, 2015
Cimzia Certolizumab pegol Arthritis, psoriatic Active September 2, 2014 April 17, 2015
Cimzia Certolizumab pegol Arthritis, rheumatoid Complete September 3, 2009 May 27, 2010
Cinqair Reslizumab Asthma, eosinophilic Active August 4, 2016
Cipralex Escitalopram oxalate Depression, Major Depressive Disorder (MDD) Withdrawn August 3, 2005
Cipralex Escitalopram oxalate Depression, Major Depressive Disorder (MDD) Complete June 8, 2006 January 24, 2007
Ciprodex Ciprofloxacin hydrochloride & dexamethasone otic suspension Otitis media with otorrhea & otitis externa, acute Complete June 15, 2007 October 18, 2007
Ciprodex Ciprofloxacin hydrochloride and dexamethasone otic suspension Otitis media with otorrhea & otitis externa, acute Complete June 11, 2004 January 26, 2005
Combigan Ophthalmic Solution Brimonidine tartrate/timolol maleate Glaucoma Complete December 15, 2003 May 27, 2004
COMPLERA Emtricitabine/ rilpivirine/ tenofovir disoproxil fumarate HIV-1 infection in antiretroviral treatment- naïve adults Complete October 19, 2011 April 19, 2012
Constella Linaclotide Irritable bowel syndrome with constipation Active December 17, 2014 September 23, 2015
Copaxone Glatiramer acetate Clinically Isolated Syndrome (CIS), suggestive of Multiple Sclerosis Complete April 29, 2009 November 25, 2009
Cortiment Budesonide Ulcerative Colitis Active May 24, 2016
Cosentyx Secukinumab Psoriasis, moderate to severe plaque Active December 8, 2014 October 28, 2015
Cosentyx Secukinumab Ankylosing spondylitis Active February 19, 2016 August 23, 2016
Cosentyx Secukinumab Arthritis, psoriatic Active February 19, 2016 August 23, 2016
Nucynta CR Tapentadol Pain, moderate to moderately severe Complete February 1, 2011 September 28, 2011
Cubicin Daptomycin Skin and skin structure infections & bacteremia Complete March 6, 2008 September 24, 2008
Cymbalta Duloxetine hydrochloride Pain, Neuropathic, Diabetic Complete February 8, 2008 August 14, 2008
Cymbalta Duloxetine hydrochloride Depressive, Major Disorder (MDD) Complete February 8, 2008 August 14, 2008
Daklinza Daclatasvir Hepatitis C, chronic Active February 13, 2015 September 21, 2015
Daklinza daclatasvir Hepatitis C, chronic Active January 6, 2016 May 19, 2016
Daxas Roflumilast Chronic obstructive pulmonary disease (COPD) Complete November 30, 2010 July 27, 2011
Denavir Penciclovir Herpes labialis (cold sores) Complete September 20, 2006 April 26, 2007
Descovy Emtricitabine /tenofovir alafenamide HIV-1 infection Active January 29, 2016 August 24, 2016
Diacomit Stiripentol Dravet Syndrome Complete October 30, 2013 October 16, 2014
Dificid Fidaxomicin Clostridium difficile infection Complete July 10, 2012 December 19, 2012
Duaklir Genuair Aclidinium bromide/formoterol fumarate dihydrate Chronic Obstructive Pulmonary Disease (COPD) Active April 1, 2015 September 18, 2015
Duodopa Levodopa / carbidopa Parkinson's disease Complete December 19, 2008 July 22, 2009
DuoTrav Travoprost and timolol maleate Glaucoma Complete March 24, 2006 August 24, 2006
Dymista Azelastine HCl and fluticasone propionate Seasonal allergic rhinitis Active December 9, 2014 June 17, 2015
Dysport Therapeutic abobotulinumtoxinA Cervical dystonia Pending January 31, 2017
Ebixa Memantine hydrochloride Dementia (Alzheimer type), moderate to severe Complete December 21, 2004 November 23, 2005
Edarbi Azilsartan medoxomil Hypertension, essential Complete March 8, 2013 October 17, 2013
Edarbyclor Azilsartan medoxomil + chlorthalidone Hypertension, essential Complete March 8, 2013 October 17, 2013
Edurant Rilpivirine HIV (treatment - naive adult) Complete July 29, 2011 February 15, 2012
Effient Prasugrel Acute Coronary Syndrome (ACS) Complete December 12, 2011 June 14, 2012
Effient Prasugrel hydrochloride Acute Coronary Syndrome (ACS) Complete May 5, 2010 February 16, 2011
Egrifta Tesamorelin Lipodystrophy, HIV-infected patients Active March 2, 2016 August 24, 2016
Elaprase Idursulfase Mucopolysarccharidosis II (MPS II), Hunter Syndrome Complete July 13, 2007 December 19, 2007
Elelyso Taliglucerase alfa Gaucher disease Active August 15, 2014 October 28, 2015
Eliquis Apixaban Thromboembolic events (venous), treatment and prevention of recurrence Complete September 18, 2014 May 7, 2015
Eliquis Apixaban Thromboembolic events, (venous) prevention Complete December 20, 2011 June 14, 2012
Eliquis Apixaban Thromboembolic events prevention, (atrial fibrillation) Complete September 25, 2012 March 20, 2013
Incruse Ellipta Umeclidinium Chronic Obstructive Pulmonary Disease (COPD) Active March 4, 2015 September 18, 2015
Emend Aprepitant Nausea and Vomiting, Chemotherapy induced Complete August 29, 2007 February 20, 2008
Restasis ophthalmic emulsion Cyclosporine Dry eye disease, Moderate to moderately severe Complete December 17, 2010 July 18, 2011
Enablex Darifenacin hydrobromide Bladder, overactive Complete October 1, 2008 April 16, 2009
Enablex Darifenacin hydrobromide Bladder, overactive Complete April 26, 2006 October 19, 2006
Entresto Sacubitril/valsartan Heart failure, NYHA class II or III Active September 18, 2015 March 18, 2016
Entyvio Vedolizumab Ulcerative Colitis Active February 20, 2015 October 28, 2015
Entyvio Vedolizumab Crohn’s disease Complete April 27, 2016 October 31, 2016
Epclusa Sofosbuvir/ velpatasvir Hepatitis C, chronic Active April 22, 2016 October 26, 2016
Esbriet Pirfenidone Pulmonary fibrosis (idiopathic, mild to moderate) Active August 29, 2014 April 15, 2015
Esbriet Pirfenidone Pulmonary fibrosis (idiopathic, mild to moderate) Complete October 5, 2012 April 18, 2013
Evra Norgelestromin/ethinyl estradiol Contraceptive, patch Complete December 19, 2003 June 23, 2004
Exelon Patch Rivastigmine Dementia (Alzheimer's type) Complete December 21, 2007 July 23, 2008
Exjade Deferasirox Iron overload Complete October 26, 2006 April 19, 2007
Eylea Aflibercept Macular edema, diabetic Complete September 16, 2014 May 7, 2015
Eylea Aflibercept Macular edema secondary to central retinal vein occlusion Complete October 17, 2014 May 7, 2015
Eylea Aflibercept Macular degeneration, age-related Complete November 18, 2013 October 20, 2014
Eylea Aflibercept Macular edema secondary to branch retinal vein occlusion Active December 14, 2015 July 27, 2016
Fabrazyme Agalsidase beta Fabry Disease Complete February 24, 2004 November 24, 2004
Fabrazyme Agalsidase beta Fabry Disease Complete December 10, 2004 May 18, 2005
Fampyra Fampridine Multiple Sclerosis, improve walking disability Withdrawn November 6, 2014
Fampyra Fampridine Multiple Sclerosis, improve walking disability Complete April 16, 2012 November 28, 2012
Fentora Fentanyl buccal Pain (breakthrough), cancer (adults) Active July 12, 2016
Ferriprox Deferiprone Transfusional iron overload Active September 24, 2015 March 18, 2016
Fibristal Ulipristal acetate Uterine fibroids (signs and symptoms) Complete April 17, 2013 November 15, 2013
Finacea Azelaic acid Rosacea Complete August 31, 2010 February 16, 2011
Firazyr Icatibant Angioedema, hereditary Active March 4, 2014 December 19, 2014
Forteo Teriparatide (rDNA origin) injection Osteoporosis, glucocorticoid induced Complete December 18, 2008 July 22, 2009
Forteo Teriparatide (rDNA origin) injection Osteoporosis Withdrawn December 18, 2008
Forteo Teriparatide (rDNA origin) injection Osteoporosis Withdrawn June 12, 2009
Forteo Teriparatide (rDNA origin) injection Osteoporosis (in women), Severe Complete October 23, 2009 March 17, 2010
Forteo Teriparatide (rDNA origin) injection Osteoporosis Withdrawn May 29, 2006
Forteo Teriparatide (rDNA origin) injection Osteoporosis Complete June 8, 2004 December 22, 2004
Forxiga Dapagliflozin Diabetes mellitus, type 2 Active September 4, 2015 April 27, 2016
Forxiga Dapagliflozin Diabetes mellitus (Type 2) Active April 30, 2015 November 20, 2015
Fosavance Alendronate sodium/cholecalciferol Osteoporosis Complete March 27, 2006 September 27, 2006
Fosrenol Lanthanum carbonate hydrate Hyperphosphatemia, end-stage renal disease Complete June 28, 2007 January 30, 2008
Fycompa Perampanel Epilepsy, partial onset seizures Complete March 8, 2013 October 17, 2013
Fycompa Perampanel Epilepsy, primary generalized tonic-clonic seizures Active November 24, 2015 May 18, 2016
Galexos Simeprevir Hepatitis C, chronic Complete August 22, 2013 June 18, 2014
Gelnique Oxybutynin Chloride Gel Bladder, overactive Complete October 25, 2011 May 24, 2012
Genotropin Somatropin Growth hormone deficiency, adult Complete May 27, 2013 December 20, 2013
Genotropin Somatropin Growth hormone deficiency, pediatric Complete May 27, 2013 December 20, 2013
Genotropin Somatropin Turner Syndrome Complete May 27, 2013 December 20, 2013
Tudorza Genuair Aclidinium bromide Chronic Obstructive Pulmonary Disease (COPD) Complete August 21, 2013 April 21, 2014
Genvoya Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide HIV-1 infection Complete September 24, 2015 March 18, 2016
Gilenya Fingolimod Multiple Sclerosis Complete May 10, 2011 November 16, 2011
Grastek Phleum pratense Allergy (grass) Complete September 30, 2013 September 24, 2014
Grastofil Filgrastim Prevention or treatment of neutropenia in various indications Complete September 11, 2015 March 18, 2016
Harvoni Ledipasvir / Sofosbuvir Hepatitis C, chronic Complete September 15, 2014 March 18, 2015
Harvoni ledipasvir, sofosbuvir Hepatitis C, chronic Active January 6, 2016 May 18, 2016
Hemangiol Propranolol Infantile hemangioma Withdrawn December 23, 2014
Hemangiol Propranolol oral solution Infantile hemangioma Active August 25, 2016
Hepsera Adefovir dipivoxil Hepatitis B Complete April 24, 2006 November 29, 2006
Hepsera Adefovir dipivoxil Hepatitis B Complete June 29, 2007 October 18, 2007
Holkira Pak Ombitasvir/paritaprevir/ritonavir and dasabuvir Hepatitis C, chronic Active December 3, 2014 June 18, 2015
Holkira Pak ombitasvir/paritaprevir/ritonavir and dasabuvir Hepatitis C, chronic Active January 6, 2016 May 19, 2016
Humira Adalimumab Ulcerative colitis Withdrawn December 23, 2013
Humira Adalimumab Arthritis, Juvenile Idiopathic Complete February 4, 2013 July 18, 2013
Humira Adalimumab Psoriasis Complete April 15, 2008 October 16, 2008
Humira Adalimumab Arthritis, Psoriatic Complete June 21, 2006 November 29, 2006
Humira Adalimumab Ankylosing spondylitis (AS) Complete November 17, 2006 June 27, 2007
Humira Adalimumab Crohn's disease Complete July 12, 2007 December 19, 2007
Humira Adalimumab Arthritis, Rheumatoid Complete September 24, 2004 February 11, 2005
Humira Adalimumab Ulcerative Colitis Active September 25, 2015 April 15, 2016
Humira Adalimumab Hidradenitis suppurativa Active November 3, 2015 May 19, 2016
Simponi I.V. Golimumab Arthritis, Rheumatoid Complete September 12, 2013 July 17, 2014
Ilaris Canakinumab Cryopyrin-Associated Periodic Syndrome (CAPS) Complete July 7, 2010 January 26, 2011
Ilaris Canakinumab Systemic juvenile idiopathic arthritis Complete December 23, 2015 June 17, 2016
Incivek Telaprevir Hepatitis C, chronic Complete December 21, 2012 June 13, 2013
Incivek Telaprevir Hepatitis C infection (genotype 1), Chronic Complete August 23, 2011 February 15, 2012
Incivek Telaprevir Hepatitis C infection, chronic Complete February 19, 2013 June 13, 2013
Inflectra Infliximab Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis Complete June 17, 2014 December 19, 2014
Inspiolto Respimat Tiotropium / olodaterol Chronic Obstructive Pulmonary Disease (COPD) Active June 4, 2015 December 17, 2015
Inspra Eplerenone Post myocardial infarction Complete May 6, 2009 November 25, 2009
Inspra Eplerenone Heart failure, NYHA class II Complete July 12, 2013 April 24, 2014
Intelence Etravirine HIV Complete April 2, 2008 August 14, 2008
Intuniv XR Guanfacine hydrochloride Attention-deficit/hyperactivity disorder (ADHD) Complete August 27, 2013 September 24, 2014
Invega Sustenna Paliperidone palmitate Schizophrenia Complete July 9, 2010 April 25, 2011
Invega Paliperidone Schizophrenia Complete November 1, 2007 May 28, 2008
Invokamet Canagliflozin and metformin hydrochloride Diabetes mellitus, type 2 Active March 3, 2016 August 25, 2016
Invokana Canagliflozin Diabetes Mellitus, Type 2 Complete February 24, 2014 January 15, 2015
Invokana Canagliflozin Diabetes mellitus, type 2 Withdrawn June 5, 2013
Iressa Gefitinib Cancer, Lung , non-small cell Complete December 22, 2003 June 23, 2004
Isentress Raltegravir HIV (treatment naïve) Complete December 4, 2009 June 23, 2010
Isentress Raltegravir HIV Complete November 29, 2007 May 14, 2008
Janumet Sitagliptin phosphate monohydrate / metformin hydrochloride Diabetes mellitus (Type 2) Complete November 4, 2009 June 23, 2010
Januvia Sitagliptin phosphate Diabetes mellitus (Type 2) Complete October 29, 2009 June 23, 2010
Januvia Sitagliptin phosphate Diabetes mellitus (Type 2) Complete December 20, 2007 June 18, 2008
Jardiance Empagliflozin Diabetes mellitus (Type 2) Active April 23, 2015 October 15, 2015
Jardiance Empagliflozin Diabetes mellitus, type 2 with high cardiovascular risk Active April 27, 2016 October 26, 2016
Jentadueto Linagliptin-metformin Diabetes mellitus (Type 2) Complete March 8, 2013 October 17, 2013
Jetrea Ocriplasmin Vitreomacular adhesion Complete June 6, 2013 December 20, 2013
Jinarc Tolvaptan Autosomal dominant polycystic kidney disease (ADPKD) Active May 29, 2015 February 24, 2016
Jurnista Hydromorphone hydrochloride Pain, Chronic (moderate to severe) Complete December 4, 2009 May 19, 2010
Juxtapid Lomitapide Hypercholesterolemia, Homozygous Familial Complete July 8, 2014 April 17, 2015
Kalydeco Ivacaftor Cystic Fibrosis (CFTR gating mutations) Complete May 1, 2014 December 19, 2014
Kalydeco Ivacaftor Cystic Fibrosis patients (G551D mutation) Complete September 27, 2012 March 22, 2013
Kalydeco Ivacaftor Cystic Fibrosis, R117H CFTR gating mutation Complete May 8, 2015 November 19, 2015
Kazano Alogliptin plus metformin Diabetes mellitus (Type 2) Complete January 30, 2014 January 15, 2015
Kevzara sarilumab Arthritis, Rheumatoid Active October 12, 2016
Kivexa Abacavir/lamivudine HIV infection Complete July 26, 2005 December 7, 2005
Komboglyze Saxagliptin + metformin Diabetes Mellitus, Type 2 Complete August 23, 2013 June 20, 2014
Komboglyze Saxagliptin + metformin Diabetes Mellitus, Type 2 Withdrawn June 6, 2013
Kuvan Sapropterin dihydrochloride Phenylketonuria (PKU). Complete July 8, 2010 January 26, 2011
Kuvan Sapropterin dihydrochloride Phenylketonuria (PKU). Complete June 1, 2011
Kuvan Sapropterin dihydrochloride Phenylketonuria (PKU) Active February 1, 2016 October 26, 2016
Lancora Ivabradine Heart failure, NYHA class II to IV Active November 8, 2016
Lantus Insulin glargine (rDNA origin) Diabetes mellitus, Type 1 & 2 Complete June 9, 2009
Lantus Insulin glargine (rDNA origin) Diabetes mellitus, Type 1 & 2 Complete March 27, 2006 October 25, 2006
Lantus Insulin glargine (rDNA origin) Diabetes mellitus, Type 1 & 2 Complete February 11, 2005 September 28, 2005
Latuda Lurasidone schizophrenia Complete July 3, 2012 January 23, 2013
Latuda Lurasidone Schizophrenia Complete May 9, 2013 December 20, 2013
Lemtrada Alemtuzumab Multiple Sclerosis, relapsing-remitting Active November 27, 2014 June 18, 2015
Lemtrada Alemtuzumab Multiple Sclerosis, relapsing Withdrawn October 1, 2013
Levemir Insulin detemir Diabetes mellitus Withdrawn February 2, 2009
Levemir Insulin detemir Diabetes mellitus Complete March 10, 2009 August 20, 2009
Levemir Insulin detemir Diabetes mellitus Type1, Pediatrics Complete March 10, 2009 August 20, 2009
Levemir Insulin detemir Diabetes mellitus Complete December 19, 2005 August 2, 2006
Lixiana NVAF Edoxaban Nonvalvular atrial fibrillation, prevention of stroke and systemic embolism Active September 9, 2016
Lixiana VTE Edoxaban Venous thromboembolism, treatment and recurrence prevention Active September 9, 2016
Lodalis Colesevelam hydrochloride Hypercholesterolemia Complete April 27, 2012 December 19, 2012
Lotemax Loteprednol etabonate Post-operative inflammation following cataract surgery Complete December 2, 2009 May 19, 2010
Lucentis Ranibizumab Choroidal neovascularisation, myopic Complete February 28, 2014 February 19, 2015
Lucentis Ranibizumab Macular edema, diabetic Complete September 14, 2011 March 19, 2012
Lucentis Ranibizumab injection Macular edema, secondary to retinal vein occlusion Complete April 25, 2012 October 18, 2012
Lucentis Ranibizumab Macular degeneration, age-related Complete July 12, 2007 March 27, 2008
Lyrica Pregabalin diabetic peripheral neuropathy Complete March 20, 2009 September 23, 2009
Lyrica Pregabalin Pain, Neuropathic Complete June 27, 2005 January 25, 2006
Pantoloc M Pantoprazole magnesium Gastric acid secretion, reduction of Complete March 17, 2006 July 20, 2006
Macugen Pegaptanib sodium Macular degeneration, age-related Complete October 20, 2005 May 25, 2006
Mictoryl Propiverine hydrochloride Overactive bladder (OAB) Active October 14, 2016
Mifegymiso Mifepristone and misoprostol Medical termination of pregnancy Active October 7, 2016
Mifegymiso Mifepristone and misoprostol Medical termination of pregnancy (gestational age up to 49 days) Withdrawn February 12, 2016
Mozobil Plerixafor Hematopoietic stem cell mobilizer in non-Hodgkin's lymphoma and multiple myeloma Complete January 24, 2012 September 26, 2012
Multaq Dronedarone hydrochloride Atrial fibrillation Complete September 18, 2009 May 27, 2010
Myfortic Mycophenolate sodium Organ rejection in allogeneic renal transplants, Prophylaxis Complete March 3, 2005 July 8, 2005
Myozyme Alglucosidase Pompe’s disease Complete October 10, 2006 June 14, 2007
Myrbetriq Mirabegron Bladder, overactive Complete November 27, 2013 November 12, 2014
Myrbetriq Mirabegron Bladder, Overactive Withdrawn March 8, 2013
Naglazyme Galsulfase (Drug Plan Submission) Mucopolysaccharidosis VI Complete August 20, 2015 February 19, 2016
Nesina Alogliptin Diabetes mellitus (Type 2) Complete January 30, 2014 January 15, 2015
Neulasta Pegfilgrastim Neutropenia Complete March 29, 2004 October 27, 2004
Neupro Rotigotine Parkinson’s Disease Complete July 31, 2013 May 28, 2014
Neupro Rotigotine Parkinson’s Disease Active May 21, 2015 November 19, 2015
Nexavar Sorafenib tablets Cancer, Renal cell carcinoma Complete July 31, 2006 February 28, 2007
Norprolac Quinagolide hydrochloride Hyperprolactinemia Complete November 23, 2005 May 17, 2006
Norprolac Quinagolide hydrochloride Hyperprolactinemia Complete December 16, 2004 September 28, 2005
Nplate Romiplostim Chronic immune (idiopathic) thrombocytopenic purpura (ITP) Complete September 29, 2009 May 27, 2010
Nucala Mepolizumab Asthma, severe eosinophilic Complete December 18, 2015 June 16, 2016
NuvaRing Etonogestrel/ethinyl estradiol Contraceptive, ring Complete May 5, 2006 November 29, 2006
Ofev Nintedanib Idiopathic pulmonary fibrosis (IPF) Active April 23, 2015 October 15, 2015
Olmetec Plus Olmesartan medoxomil + hydrochlorothiazide Hypertension Complete November 28, 2008 May 27, 2009
Olmetec Olmesartan medoxomil Hypertension Complete November 28, 2008 May 27, 2009
Omnaris Ciclesonide nasal spray Allergic Rhinitis (seasonal and perennial) Complete May 7, 2008 November 12, 2008
Omnitrope Somatropin (rDNA origin) Growth hormone deficiency in children and adults Complete June 12, 2009
Onbrez Indacaterol Chronic Obstructive Pulmonary Disease (COPD), maintenance bronchodilator treatment Complete February 29, 2012 August 16, 2012
Onglyza Saxagliptin Diabetes mellitus (Type 2) Withdrawn May 28, 2012
Onglyza Saxagliptin Diabetes mellitus (Type 2) Complete November 9, 2009 June 17, 2010
Onglyza Saxagliptin Diabetes mellitus (Type 2) Complete May 9, 2013 November 15, 2013
Onsolis Fentanyl Citrate Pain (breakthrough), cancer (adults) Withdrawn May 10, 2011
Onsolis Fentanyl Citrate Pain (breakthrough), cancer (adults) Complete August 22, 2011 February 15, 2012
Opsumit Macitentan Pulmonary arterial hypertension Complete December 18, 2015 January 28, 2015
Oralair Grass Pollen Allergen Extract Allergic rhinitis (grass pollen) Complete September 21, 2012 March 20, 2013
Orencia Abatacept Arthritis, Rheumatoid Complete November 29, 2012 July 18, 2013
Orencia Abatacept Arthritis, Juvenile Idiopathic & Juvenile Rheumatoid Complete August 29, 2008 April 22, 2009
Orencia Abatacept Arthritis, Rheumatoid Complete December 2, 2009 June 17, 2010
Orencia Abatacept Arthritis, Rheumatoid Complete October 26, 2006 June 27, 2007
Orkambi lumacaftor/ivacaftor Cystic Fibrosis, F508del CFTR mutation Active January 28, 2016 October 26, 2016
Otezla Apremilast Psoriasis, moderate to severe plaque Active October 8, 2014 July 22, 2015
Otezla Apremilast Arthritis, psoriatic Active June 8, 2015 December 17, 2015
Otezla Apremilast Psoriasis, moderate to severe plaque Active March 3, 2016 October 26, 2016
Ozurdex Dexamethasone intravitreal implant Macular edema following central retinal vein occlusion Complete September 1, 2011 April 25, 2012
Pegasys RBV Peginterferon alfa-2a and Ribavirin Hepatitis C, chronic Complete May 14, 2004 October 14, 2004
Pheburane Sodium phenylbutyrate Urea cycle disorders Active October 20, 2015 April 15, 2016
Picato Ingenol mebutate Actinic keratosis Complete May 26, 2014 October 22, 2014
Picato Ingenol mebutate Keratosis, actinic Complete May 9, 2013 January 22, 2014
Plegridy Peginterferon beta-1a Multiple Sclerosis, relapsing Active June 26, 2015 December 17, 2015
Teveten Plus Eprosartan mesylate/ hydrochlorothiazide Hypertension, Essential Complete July 8, 2004 December 15, 2004
Pradaxa Dabigatran etexilate Thromboembolism (venous), prevention Complete July 8, 2008 January 28, 2009
Pradaxa Dabigatran etexilate Atrial fibrillation prevention of stroke and systemic embolism Cancelled May 31, 2010
Pradaxa Dabigatran etexilate Atrial fibrillation prevention of stroke and systemic embolism Complete October 28, 2010 June 22, 2011
Pradaxa Dabigatran etexilate Atrial fibrillation prevention of stroke and systemic embolism Complete March 18, 2013 July 18, 2013
Praluent Alirocumab Primary hypercholesterolemia (non-familial and heterozygous familial), mixed dyslipidemia Active January 12, 2016 July 20, 2016
Praxbind Idarucizumab (Drug Plan Submission) Reversal of dabigatran anticoagulant effects Withdrawn May 30, 2016
Prexige Lumiracoxib Osteoarthritis (Knee) Complete December 15, 2006 July 25, 2007
Prezcobix Darunavir/cobicistat HIV Infection Complete May 22, 2014 March 18, 2015
Prezista Darunavir HIV (treatment naive) Complete March 27, 2009 October 14, 2009
Prezista Darunavir HIV infection (Pediatric) Complete December 22, 2009 June 17, 2010
Prezista Darunavir HIV infection Complete August 29, 2006 February 14, 2007
Pristiq Desvenlafaxine succinate Depressive, Major Disorder (MDD) Complete March 5, 2009 September 23, 2009
Prolia Denosumab Osteoporosis, postmenopausal women Complete August 26, 2010 March 30, 2011
Prolia Denosumab (Drug Plan Submission) Osteoporosis, men Complete March 10, 2015 September 21, 2015
Prolia Denosumab Osteoporosis, postmenopausal women Complete October 26, 2015 May 20, 2016
Quinsair Levofloxacin Cystic fibrosis with chronic pulmonary Pseudomonas aeruginosa infections Active May 31, 2016 November 21, 2016
Ralivia Tramadol hydrochloride Pain Complete October 29, 2007 June 25, 2008
RAPAFLO Silodosin Prostatic Hyperplasia, benign Complete October 25, 2011 April 19, 2012
Raptiva Efalizumab Psoriasis, moderate to severe chronic plaque Complete October 25, 2005 August 24, 2006
Raptiva Efalizumab Psoriasis, moderate to severe chronic plaque Complete June 19, 2007
Rasilez Aliskiren Hypertension Complete November 30, 2007 June 25, 2008
Ravicti glycerol phenylbutyrate Urea cycle disorders Active August 30, 2016
Rebif Interferon beta-1a Clinically Isolated Syndrome Complete March 8, 2013 August 15, 2013
Relistor Methylnaltrexone bromide Constipation, Opioid-induced Complete May 7, 2008 January 28, 2009
Relpax Eletriptan hydrobromide Migraine Complete September 21, 2004 March 23, 2005
Remicade Infliximab Ulcerative Colitis Complete September 29, 2008 April 22, 2009
Remodulin Treprostinil sodium Pulmonary arterial hypertension (NYHA Class III and IV patients) Complete July 14, 2004 November 17, 2004
Remodulin Treprostinil sodium Pulmonary arterial hypertension (NYHA Class III and IV patients) Complete February 24, 2006 July 20, 2006
Remsima Infliximab Ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis Withdrawn May 30, 2014
Repatha Evolocumab Primary hyperlipidemia and mixed dyslipidemia Active June 30, 2015 February 19, 2016
Replagal Agalsidase alfa Fabry Disease Complete February 19, 2004 November 24, 2004
Resotran Prucalopride Constipation, chronic Complete January 30, 2012 July 19, 2012
Spiriva Respimat Tiotropium bromide Chronic Obstructive Pulmonary Disease (COPD) Active December 23, 2014 July 16, 2015
Revatio Sildenafil citrate Pulmonary arterial hypertension (WHO class II and III) Complete September 20, 2006 February 14, 2007
Revestive Teduglutide Short Bowel Syndrome (SBS) Active November 26, 2015 July 27, 2016
Revolade Eltrombopag Thrombocytopenia associated with chronic hepatitis c infection Complete March 31, 2014 March 18, 2015
Revolade Eltrombopag olamine Thrombocytopenic purpura chronic immune (idiopathic) Complete April 26, 2011 October 24, 2011
Reyataz Atazanavir HIV infection Complete December 16, 2003 May 27, 2004
Rituxan Rituximab Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA), remission induction (adults) Complete February 24, 2012 August 16, 2012
Rituxan Rituximab Arthritis, Rheumatoid Complete June 26, 2006 February 14, 2007
Rosiver Ivermectin Rosacea Active April 30, 2015 November 19, 2015
Samsca Tolvaptan Hyponatremia, non-hypovolemic Complete July 3, 2012 February 13, 2013
Saphris Asenapine Schizophrenia Complete December 12, 2011 June 14, 2012
Saphris Asenapine Bipolar I disorder Complete December 12, 2011 June 14, 2012
Sativex Delta-9-tetrahydrocannabinol/cannabidiol Pain, cancer (adjunctive analgesia to maximum tolerated strong opioids) Complete August 7, 2007 February 20, 2008
Sativex Delta-9-tetrahydrocannabinol/cannabidiol Pain, Neuropathic (adjunctive) in MS. Complete February 27, 2007 September 26, 2007
Sebivo Telbivudine Hepatitis B (chronic) Complete December 4, 2006 September 26, 2007
Seebri Glycopyrronium bromide Chronic Obstructive Pulmonary Disease (COPD), maintenance bronchodilator treatment Complete November 30, 2012 May 15, 2013
Sensipar Cinacalcet hydrochloride Secondary hyper-parathyroidism in chronic kidney disease Complete August 20, 2004 March 23, 2005
Signifor Pasireotide diaspartate Cushing’s Disease Complete February 27, 2014 February 24, 2015
Silkis Calcitriol Psoriasis, mild to moderate plaque Complete March 15, 2010 September 22, 2010
Simbrinza Brinzolamide / brimonidine Glaucoma and ocular hypertension Complete November 3, 2014 June 17, 2015
Simponi Golimumab Arthritis, Rheumatoid Complete September 3, 2009 March 17, 2010
Simponi Golimumab Arthritis, psoriatic Complete September 3, 2009 March 17, 2010
Simponi Golimumab Ankylosing spondylitis Complete September 3, 2009 March 17, 2010
Simponi Golimumab Ulcerative colitis Complete July 12, 2013 March 19, 2014
Sivextro Tedizolid phosphate Acute bacterial skin and skin structure infections Withdrawn January 16, 2015
Soliris Eculizumab Hemolytic Uremic Syndrome, Atypical Complete January 7, 2013 July 18, 2013
Soliris Eculizumab Paroxysmal nocturnal hemoglobinuria (PNH) Complete September 18, 2009 February 18, 2010
Soliris Eculizumab Hemolytic Uremic Syndrome, Atypical Complete February 9, 2015
Somavert Pegvisomant acromegaly Complete January 25, 2006 August 2, 2006
Sovaldi Sofosbuvir Hepatitis C, chronic Complete October 1, 2013 August 18, 2014
Sovaldi sofosbuvir Hepatitis C, chronic Active January 6, 2016 May 18, 2016
Spriafil Posaconazole Aspergillus and Candida infections Complete May 24, 2007 January 30, 2008
Stalevo Carbidopa, levodopa and entacapone Parkinsons Disease Complete April 15, 2008 October 16, 2008
Stelara Ustekinumab Arthritis, Psoriatic Complete October 30, 2013 October 20, 2014
Stelara Ustekinumab Psoriasis Complete January 7, 2009 June 17, 2009
Stelara ustekinumab Crohn’s disease Active September 12, 2016
Strattera Atomoxetine hydrochloride Attention deficit hyperactivity disorder Complete September 25, 2006
Strattera Atomoxetine hydrochloride Attention deficit hyperactivity disorder Complete January 25, 2005 September 28, 2005
Strensiq Asfotase alfa Hypophosphatasia, pediatric-onset Active August 21, 2015 March 23, 2016
Stribild Elvitegravir/ Cobicistat/ Emtricitabine/ Tenofovir Disoproxil Fumarate HIV-1 infection Complete November 30, 2012 May 15, 2013
Sublinox Zolpidem tartrate Insomnia, short-term treatment Complete March 7, 2013 September 25, 2013
Suboxone Buprenorphine/naloxone Opioid drug dependence (Substitution treatment) Complete March 6, 2008 September 24, 2008
Sunvepra Asunaprevir Hepatitis C, chronic Active February 13, 2015 July 20, 2016
Sutent Sunitinib Gastrointestinal stromal tumour (GIST) Complete July 20, 2006 March 28, 2007
Sutent Sunitinib malate Cancer, Metastatic renal cell carcinoma Complete September 20, 2006 April 26, 2007
Synjardy Empagliflozin and metformin Diabetes mellitus (Type 2) Active April 29, 2016 October 25, 2016
Taltz Ixekizumab Psoriasis, moderate to severe plaque Active March 23, 2016 October 25, 2016
Tarceva Erlotinib Cancer, Lung , non-small cell Complete July 19, 2005 December 7, 2005
Targin Oxycodone / naloxone Pain, Moderate to severe and relief of opioid-induced constipation Cancelled November 30, 2010
Targin Oxycodone HCI / naloxone HCI Pain, Moderate to severe and relief of opioid-induced constipation Complete July 5, 2011 January 25, 2012
TBC Darunavir / cobicistat HIV infection Withdrawn April 4, 2014
TBC emtricitabine/rilpivirine/ tenofovir alafenamide HIV-1 infection Active November 24, 2016
TBC Brexpiprazole Schizophrenia February 1, 2017
TBC Etanercept (Subsequent Entry Biologic) Ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, rheumatoid arthritis Pending February 2, 2017
TBC Obeticholic Acid Primary biliary cholangitis Active December 22, 2016
TBD Glatiramer acetate Multiple Sclerosis, relapsing - remitting Pending January 20, 2017
Tecfidera Dimethyl fumarate Multiple Sclerosis, relapsing Complete February 4, 2013 September 25, 2013
Technivie Ombitasvir/ paritaprevir/ ritonavir Hepatitis C, chronic (genotype 4) Active September 4, 2015 March 18, 2016
Telzir Fosamprenavir calcium HIV infection Complete January 24, 2005 June 16, 2005
Thelin Sitaxsentan sodium Pulmonary arterial hypertension (WHO class II and III) Complete May 5, 2008 January 28, 2009
Thelin Sitaxsentan sodium Pulmonary arterial hypertension (WHO class II and III) Complete June 22, 2007 January 30, 2008
Tivicay Dolutegravir HIV infection Active October 18, 2013 August 18, 2014
Toctino Alitretinoin Eczema Complete May 6, 2011 October 24, 2011
Toviaz Fesoterodine fumarate Bladder, overactive Complete April 27, 2012 October 18, 2012
Trajenta Linagliptin Diabetes mellitus, Type 2 Complete August 23, 2011 February 15, 2012
Tramacet Tramadol hydrochloride /acetaminophen Acute pain Complete October 2, 2006 May 17, 2007
Trelstar Triptorelin pamoate Cancer, prostate Complete February 27, 2006 July 20, 2006
Tridural Tramadol hydrochloride Pain Complete November 29, 2007 April 17, 2008
Trintellix Vortioxetine Depression, Major Depressive Disorder (MDD) Withdrawn October 31, 2014
Triumeq Dolutegravir / abacavir / lamivudine HIV Infection Complete July 31, 2014 April 17, 2015
Trosec Trospium chloride Bladder, overactive Complete March 24, 2006 August 24, 2006
Trulicity Dulaglutide Diabetes mellitus, Type 2 Active December 22, 2015 June 16, 2016
Truvada Emtricitabine/tenofovir disoproxil fumarate HIV infection Complete July 7, 2008 December 17, 2008
Truvada Emtricitabine/tenofovir disoproxil fumarate HIV infection Complete May 29, 2006 October 25, 2006
Truvada Emtricitabine/tenofovir disoproxil fumarate HIV-1 infection, pre-exposure prophylaxis Active March 3, 2016 August 24, 2016
Twynsta Telmisartan / Amlodipine Hypertension, Essential Cancelled July 9, 2010
Twynsta Telmisartan/ Amlodipine Hypertension, Essential Complete August 23, 2011 December 16, 2011
Tysabri Natalizumab Multiple Sclerosis, relapsing-remitting Complete May 6, 2008 February 25, 2009
Tysabri Natalizumab Multiple Sclerosis, relapsing-remitting Complete October 26, 2006 April 26, 2007
Uloric Febuxostat Gout Complete October 27, 2010 April 25, 2011
Uptravi Selexipag Pulmonary arterial hypertension (WHO class II and III) Active March 31, 2016 October 28, 2016
Vantas Histrelin acetate Cancer, prostate Complete September 20, 2006 April 26, 2007
Vesicare Solifenacin succinate Bladder, overactive Complete January 5, 2009 June 17, 2009
Vesicare Solifenacin succinate Bladder, overactive Complete July 24, 2006 January 24, 2007
VesiFlow Solifenacin succinate / tamsulosin hydrochloride Benign prostatic hyperplasia (BPH)-associated lower urinary tract symptoms Withdrawn April 6, 2015
VFEND Voriconazole Candidemia Complete March 24, 2006 October 25, 2006
VFEND Voriconazole Aspergillosis, Invasive Withdrawn August 24, 2004
VFEND Voriconazole Aspergillosis, Invasive Complete October 25, 2004 April 14, 2005
Viacoram perindopril arginine / amlodipine Hypertension, essential Active May 2, 2016 October 26, 2016
Victoza Liraglutide Diabetes mellitus, Type 2 Complete November 29, 2010 September 28, 2011
Victoza Liraglutide Diabetes Mellitus, Type 2 Active October 20, 2016
Victrelis Boceprevir Hepatitis C, chronic Complete December 21, 2012 June 13, 2013
Victrelis Boceprevir Hepatitis C, chronic Complete May 3, 2011 October 24, 2011
Victrelis Boceprevir Hepatitis C infection, chronic Complete February 19, 2013 June 13, 2013
Vimizim Elosulfase alfa Mucopolysaccharidosis IVA (Morquio A syndrome) Complete August 5, 2014 March 25, 2015
Vimizim Elosulfase alfa Mucopolysaccharidosis IVA (Morquio A syndrome) Active November 10, 2015 May 20, 2016
Vimpat Lacosamide Epilepsy, partial onset seizures (POS) Complete October 25, 2010 April 25, 2011
Viread Tenofovir disoproxil fumarate HIV infection Complete July 7, 2008
Viread Tenofovir disoproxil fumarate Hepatitis B (chronic) Complete October 2, 2008 March 18, 2009
Viread Tenofovir disoproxil fumarate HIV infection Complete August 11, 2005 March 15, 2006
Viread Tenofovir disoproxil fumarate HIV infection Complete February 23, 2004 August 25, 2004
Visanne Dienogest Pain (pelvic) associated with endometriosis Complete October 18, 2011 April 19, 2012
Volibris Ambrisentan Pulmonary arterial hypertension (WHO class II and III) Complete July 9, 2008 December 17, 2008
VPRIV Velaglucerase alfa Gaucher Disease Complete October 28, 2010 April 25, 2011
Vyvanse Lisdexamfetamine dimesylate Attention deficit hyperactivity disorder Complete July 10, 2009 December 18, 2009
Xarelto Rivaroxaban Atrial fibrillation, stroke prevention Complete October 21, 2011 April 19, 2012
Xarelto Rivaroxaban Deep-Vein Thrombosis (treatment), without Symptomatic Pulmonary Embolism Complete February 27, 2012 August 16, 2012
Xarelto Rivaroxaban Deep-Vein Thrombosis (treatment), without Symptomatic Pulmonary Embolism Complete October 10, 2012
Xarelto Rivaroxaban Thromboembolism (venous), prevention Complete May 7, 2008 December 17, 2008
Xarelto Rivaroxaban Thromboembolism (venous) prevention Complete June 24, 2011
Xarelto Rivaroxaban stroke prevention in patients with atrial fibrillation. Complete March 18, 2013 July 18, 2013
Xarelto Rivaroxaban Thromboembolic events (venous), pulmonary embolism Complete May 6, 2013 March 26, 2014
Xeljanz Tofacitinib Arthritis, Rheumatoid Active May 5, 2014 April 17, 2015
Xeomin Clostridium botulinum neurotoxin type A, free from complexing proteins Blepharospasm Complete June 12, 2009 December 16, 2009
Xeomin Clostridium botulinum neurotoxin type A, free from complexing proteins Cervical Dystonia Complete June 12, 2009 December 16, 2009
Xeomin Clostridium botulinum neurotoxin type A, free from complexing proteins Spasticity, Post-stroke Complete June 12, 2009 December 16, 2009
XGEVA Denosumab Prevention of skeletal-related events due to bone metastases from solid tumours Complete June 6, 2011 November 16, 2011
Xgeva Denosumab (Drug Plan Submission) Prevention of skeletal-related events due to bone metastases from breast cancer Active July 31, 2015 February 25, 2016
Xgeva Denosumab (Drug Plan Submission) Prevention of skeletal-related events due to bone metastases from other solid tumors (excluding breast and prostate cancer), including non-small cell lung cancer Complete July 31, 2015 March 23, 2016
Xiaflex Collagenase clostridium histolyticum Dupuytren’s contracture with a palpable cord Complete August 30, 2012 March 27, 2013
XigDuo dapagliflozin/metformin hydrochloride Diabetes Mellitus, Type 2 Active January 7, 2016 July 20, 2016
Zytram XL Tramadol hydrochloride Pain, acute Withdrawn November 3, 2006
Zytram XL Tramadol hydrochloride Pain, acute Complete March 15, 2007 September 26, 2007
Xolair Omalizumab Urticaria, chronic idiopathic Complete September 22, 2014 May 7, 2015
Xolair Omalizumab Asthma, severe persistent Suspended April 18, 2005
Xolair Omalizumab Asthma, severe persistent Complete October 13, 2005 March 7, 2006
Xolair Omalizumab (Drug Plan Submission) Asthma, severe persistent Active November 18, 2015 May 18, 2016
Xyrem Sodium oxybate Narcolepsy Complete July 9, 2008 January 28, 2009
Xyrem Sodium oxybate Narcolepsy Withdrawn August 29, 2007
Yasmin Drospirenone /ethinyl estradiol Contraceptive, oral Complete January 20, 2005 June 16, 2005
Zavesca Miglustat Gaucher disease Complete May 13, 2004 November 24, 2004
Zaxine Rifaximin Encephalopathy, Hepatic Complete August 5, 2014 April 16, 2015
Zeldox Ziprasidone hydrochloride Schizophrenia and related psychotic disorders Complete January 10, 2008 August 14, 2008
Zenhale Mometasone/formoterol Asthma maintenance (adults, children 12 or older) Complete June 6, 2012 December 19, 2012
Zepatier Elbasvir/grazoprevir Hepatitis C, chronic Active October 27, 2015 May 19, 2016
Zinbryta Daclizumab beta Multiple Sclerosis, relapsing Active December 20, 2016