| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| Rytary® | carbidopa/ levodopa | Impax | Parkinson's disease | 2015/01/07 | 28:36.16 - Dopamine Precursors | 5S | 203312 |
| Savaysa® | edoxaban tosylate | Daiichi Sankyo | atrial fibrillation (AF); deep vein thrombosis (DVT); pulmonary embolism (PE) | 2015/01/08 | 20:12.04.14 - Direct Factor Xa Inhibitors | 1S | |
| phoxillum | Gambro Lundia | replacement solution in Continuous Renal Replacement Therapy (CRRT) | 2015/01/13 | 40:12 - Replacement Preparations | 1 | ||
| prismasol | Gambro Lundia | replacement solution in Continuous Renal Replacement Therapy (CRRT) | 2015/01/13 | 40:12 - Replacement Preparations | |||
| Cosentyx® | secukinumab | Novartis | plaque psoriasis | 2015/01/21 | 84:92 - Skin and Mucous Membrane Agents, Miscellaneous | ||
| Prestalia® | perindopril; amlodipine | Symplmed | hypertension | 2015/01/21 | 24:08.44.04 - Angiotensin-Converting Enzyme (ACE) Inhibitors; 24:28.08 - Dihydropyridines | 4S | |
| Natpara® | parathyroid hormone | NPS | hypocalcemia in patients with hypoparathyroidism | 2015/01/23 | 68:24 - Parathyroid | ||
| Triferic® | ferric pyrophosphate citrate | Rockwell | iron deficiency in patients with hemodialysis-dependent chronic kidney disease (HDD-CKD) | 2015/01/23 | 20:04.04 - Iron Preparations | 5S | |
| Prezcobix® | darunavir; cobicistat | Janssen | HIV infection | 2015/01/29 | 8:18.08.08 - HIV Protease Inhibitors; 92:92 - Other Miscellaneous Therapeutic Agents | 4S | |
| Evotaz® | atazanavir; cobicistat | BMS | HIV infection | 2015/01/29 | 8:18.08.08 - HIV Protease Inhibitors; 92:92 - Other Miscellaneous Therapeutic Agents | 4S | |
| Glyxambi® | empagliflozin; linagliptin | Boehringer Ingelheim | type 2 diabetes mellitus | 2015/01/30 | 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors; 68:20.05 - Dipeptidyl Peptidase-4 (DPP-4) Inhibitors | 4S | |
| Ibrance® | palbociclib | Pfizer | ER+, HER2- advanced breast cancer in post-menopausal women | 2015/02/03 | 10:00 - Antineoplastic Agents | 1 | |
| Dutrebis® | lamivudine; raltegravir | Merck Sharp Dohme | HIV infection | 2015/02/06 | 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors; 8:18.08.12 - HIV Integrase Inhibitors | 4 | |
| Lenvima® | lenvatinib | Eisai | differentiated thyroid cancer (DTC) | 2015/02/13 | 10:00 - Antineoplastic Agents | 1 | |
| Farydak® | panobinostat | Novartis | multiple myeloma | 2015/02/23 | 10:00 - Antineoplastic Agents | 1P | |
| Avycaz® | ceftazidime; avibactam | Cerexa | complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI) | 2015/02/25 | 8:12.06.12 - Third Generation Cephalosporins; beta-lactamase inhibitor | 1P | |
| Toujeo® | insulin glargine | Sanofi Aventis | diabetes mellitus | 2015/02/25 | 68:20.08 - Insulins | 5S | |
| Zarxio® | filgrastim-sndz | Sandoz | neutropenia | 2015/03/06 | 20:16 - Hematopoietic Agents | 1 | |
| Cresemba® | isavuconazonium sulfate | Astellas | invasive aspergillosis or mucomycosis | 2015/03/06 | 8:14.08 - Azoles | 1 | |
| Unituxin® | dinutuximab | United | pediatric patients with high-risk neuroblastoma | 2015/03/10 | 10:00 - Antineoplastic Agents | 1 | |
| Cholbam® | cholic acid | Asklepion | bile acid synthesis disorders due to single enzyme defects | 2015/03/17 | 56:92 - GI Drugs, Miscellaneous | 1P | |
| Evarrest® | fibrin sealant patch (fibrinogen; thrombin) | Omrix | hemostasis during surgery | 2015/03/26 | 84:92 - Skin and Mucous Membrane Agents, Misc | ||
| Jadenu® | deferasirox | Novartis | iron toxicity | 2015/03/30 | 64:00 - Heavy Metal Antagonists | 5P | |
| Corlanor® | ivabradine | Amgen | angina pectoris | 2015/04/15 | 24:04.92 - Cardiac Drugs, Miscellaneous | 1P | |
| Glatopa® | glatiramer acetate | Sandoz | multiple sclerosis (MS) | 2015/04/16 | 92:20 - Immunomodulatory Agents | ||
| Aptensio XR® | methylphenidate | Rhodes | ADHD | 2015/04/17 | 28:20.32 - Respiratory and CNS Stimulants | 3S | |
| Kybella® | deoxycholic acid | Kythera | reduction of localized subcutaneous fat deposits in the submental region | 2015/04/29 | 92:92 - Other Miscellaneous Therapeutic Agents | 1 | |
| Raplixa® | fibrin sealant (human) | The Medicines Company | hemostasis for mild to moderate bleeding during surgery | 2015/04/30 | 84:92 - Skin and Mucous Membrane Agents, Misc | 1 | |
| Ixinity® | coagulation factor IX (recombinant) | Cangene | control and prevention of bleeding episodes in hemophilia B and for perioperative management | 2015/05/14 | 20:28.16 - Hemostatics | ||
| Hycofenix® | hydrocodone; pseudoephedrine; guaifenesin | Mikart | symptomatic relief of cough, nasal congestion, and to loosen mucus associated with the common cold | 2015/05/14 | 48:08 - Antitussives; 12:12.12 - α- and β-adrenergic agonists; 48:16 - Expectorants | 4 | |
| Flowtuss® | hydrocodone; guaifenesin | Mikart | symptomatic relief of cough and to loosen mucus associated with the common cold | 2015/05/14 | 48:08 - Antitussives; 48:16 - Expectorants | 4 | |
| Invega Trinza® | paliperidone | Janssen | schizophrenia | 2015/05/18 | 28:16.08.04 - Atypical Antipsychotics | 5 | |
| Stiolto Respimat® | tiotropium; olodaterol | Boehringer Ingelheim | chronic obstructive pulmonary disease (COPD) | 2015/05/21 | 12:08.08 - Antimuscarinics/ Antispasmodics; 12:12.08.12 - Selective β2-Adrenergic Agonists | 1 | |
| Viberzi® | eluxadoline | Furiex Pharma | irritable bowel syndrome with diarrhea (IBS-D) | 2015/05/27 | 56:92 - GI Drugs, Miscellaneous | 1 | |
| Kengreal® | cangrelor tetrasodium | Medicines Co. | percutaneous coronary intervention (PCI) | 2015/06/22 | 20:12.18 - Platelet-aggregation Inhibitors | 1S | |
| Orkambi® | lumacaftor; ivacaftor | Vertex | cystic fibrosis | 2015/07/02 | 48:14.04 - Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Correctors; 48:14.12 - Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Potentiators | 1 | |
| Entresto® | sacubitril; valsartan | Novartis | heart failure | 2015/07/07 | 24:32.92 - Renin-Angiotensin-Aldosterone System Inhibitors, Misc (new); 24:32.08 - Angiotensin II Receptor Antagonists | 1 | |
| Rexulti® | brexpiprazole | Otsuka | schizophrenia; major depressive disorder (MDD) | 2015/07/10 | 28:16.08.04 - Atypical Antipsychotics | 1 | |
| Envarsus XR® | tacrolimus | Veloxis | prophylaxis of kidney transplant rejection | 2015/07/10 | 92:44 - Immunosuppressive Agents | 3S | |
| Epiduo Forte® | adapalene; benzoyl peroxide | Galderma | acne vulgaris | 2015/07/15 | 84:92 - Skin and Mucous Membrane Agents, Miscellaneous | 5S | |
| Praluent® | alirocumab | Sanofi Aventis | heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease | 2015/07/24 | 24:06.24 - Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Inhibitors (new) | 1 | |
| Odomzo® | sonidegib | Novartis | locally advanced basal cell carcinoma (BCC) | 2015/07/24 | 10:00 - Antineoplastic Agents | 1S | |
| Daklinza® | daclatasvir | BMS | chronic HCV genotype 3 infection | 2015/07/24 | 8:18.40.24 - HCV Replication Complex Inhibitors | 1 | |
| Technivie® | ombitasavir; paritaprevir; ritonavir | Bayer | chronic HCV genotype 4 infection | 2015/07/24 | 8:18.40.24 - HCV Replication Complex Inhibitors; 8:18.40.20 - HCV Protease Inhibitors | 5P | |
| Finacea® | azelaic acid | Abbvie | topical treatment of inflammatory papules and pustules of mild to moderate rosacea | 2015/07/29 | 84:92 - Miscellaneous Skin and Mucous Membrane Agents | 3S | |
| Spritam® | levetiracetam | Aprecia | epilepsy | 2015/07/31 | 28:12.92 - Anticonvulsants, Miscellaneous | 3P | |
| Keveyis® | dichlorphenamide | Taro | primary hyperkalemic/ hypokalemic periodic paralysis | 2015/08/07 | 92:26 - Carbonic Anhydrase Inhibitors (updated 2016/05/13); (previously: 92:92 - Other Miscellaneous Therapeutic Agents) | ||
| Bekyree® | desogestrel (0.15 mg); ethinyl estradiol (0.02 mg) | Lupin | contraception | 2015/08/12 | 68:12 - Contraceptives | ||
| Isibloom® | desogestrel (0.15 mg); ethinyl estradiol (0.03 mg) | Sandoz | contraception | 2015/08/12 | 68:12 - Contraceptives | ||
| Addyi® | flibanserin | Sprout | female hypoactive sexual desire disorder (HSDD) | 2015/08/18 | 28:92 - Central Nervous System Agents, Miscellaneous | 1S | |
| Synjardy® | empagliflozin; metformin | Boehringer Ingelheim | type 2 diabetes mellitus | 2015/08/26 | 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors; 68:20.04 - Biguanides | 4 | |
| Repatha® | evolocumab | Amgen | heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease | 2015/08/27 | 24:06.24 - Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Inhibitors (new) | 1S | |
| Varubi® | rolapitant | Tesaro | nausea and vomiting associated with emetogenic chemotherapy | 2015/09/01 | 56:22.92 - Antiemetics, Miscellaneous | 1 | |
| Xuriden® | uridine triacetate | Wellstat | hereditary orotic aciduria | 2015/09/08 | 92:92 - Other Miscellaneous Therapeutic Agents | 1 | |
| Vraylar® | cariprazine | Forest | schizophrenia and bipolar disorder | 2015/09/17 | 28:16.08.04 - Atypical Antipsychotics | 1 | |
| Tolak® | fluorouracil | Hill Dermac | actinic keratosis lesions of the face, ears, and scalp | 2015/09/18 | 84:92 - Skin and Mucous Membrane Agents, Miscellaneous | 5S | |
| Lonsurf® | trifluridine; tipiracil | Taiho | previously treated metastatic colorectal cancer | 2015/09/22 | 10:00 - Antineoplastic Agents | 1 | |
| Tresiba® | insulin degludec | Novo Nordisk | diabetes mellitus | 2015/09/25 | 68:20.08 - Insulins | 1S | |
| Ryzodeg® 70/30 | insulin degludec; insulin aspart | Novo Nordisk | diabetes mellitus | 2015/09/25 | 68:20.08 - Insulins | 4 | |
| Aristada® | aripiprazole lauroxil | Alkermes | schizophrenia | 2015/10/05 | 28:16.08.04 - Atypical Antipsychotics | 1 | |
| Praxbind® | idarucizumab | Boehringer Ingelheim | reversal of the anticoagulant effects of dabigatran | 2015/10/16 | 20:28.92 - Antihemorrhagic Agents, Misc (new) | 1 | |
| Coagadex® | Factor X (Human) | Bio Products | hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding | 2015/10/20 | 20:28.16 - Hemostatics | 1 | |
| Veltassa® | patiromer sorbitex calcium | Relypsa | hyperkalemia | 2015/10/21 | 40:18.18 - Potassium-removing Agents | 1 | |
| Yondelis® | trabectedin | Janssen | liposarcoma, leiomyosarcoma | 2015/10/23 | 10:00 - Antineoplastic Agents | 1P | |
| Strensiq® | asfotase alfa | Alexion | perinatal/infantile- and juvenile-onset hypophosphatasia (HPP) | 2015/10/23 | 44:00 - Enzymes | 1P | |
| Belbuca® | buprenorphine | Endo | severe pain requiring around-the-clock long-term treatment | 2015/10/23 | 28:08.12 - Opiate Partial Agonists | 3S | |
| Imlygic® | talimogene laherparepvec | Amgen | melanoma | 2015/10/27 | 10:00 - Antineoplastic Agents | 1 | |
| Seebri® Neohaler | glycopyrrolate | Novartis | chronic obstructive pulmonary disease (COPD) | 2015/10/29 | 12:08.08 - Antimuscarinics/Antispasmodics | 3S | |
| Utibron® Neohaler | indacaterol; glycopyrrolate | Novartis | chronic obstructive pulmonary disease (COPD) | 2015/10/29 | 12:12.08.12 - Selective beta-2-Adrenergic Agonists; 12:08.08 - Antimuscarinics/Antispasmodics | 4S | |
| Nucala® | mepolizumab | GSK | severe asthma with an eosinophilic phenotype | 2015/11/04 | 48:10 - Anti-Inflammatory Agents | 1 | |
| Genvoya® | elvitegravir; cobicistat; emtricitabine; tenofovir | Gilead | HIV-1 | 2015/11/05 | 8:18.08.12 - HIV Integrase Inhibitors; 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors | 1 | |
| Cotellic® | cobimetinib | Genentech | unresectable or metastatic melanoma | 2015/11/10 | 10:00 - Antineoplastic Agents | 1 | |
| Tagrisso® | osimertinib | AstraZeneca | advanced non-small cell lung cancer (NSCLC) | 2015/11/13 | 10:00 - Antineoplastic Agents | 1 | |
| Adynovate® | antihemophilic factor (recombinant), PEGylated | Baxalta | hemophilia A | 2015/11/13 | 20:28.16 - Hemostatics | 1 | |
| Darzalex® | daratumumab | Janssen | multiple myeloma | 2015/11/16 | 10:00 - Antineoplastic Agents | 1 | |
| Ninlaro® | ixazomib | Takeda | multiple myeloma | 2015/11/20 | 10:00 - Antineoplastic Agents | 1 | |
| Portrazza® | necitumumab | Eli Lilly | advanced non-small cell lung cancer (NSCLC) | 2015/11/24 | 10:00 - Antineoplastic Agents | 1 | |
| Empliciti® | elotuzumab | Bristol-Myers Squibb | multiple myeloma | 2015/11/30 | 10:00 - Antineoplastic Agents | 1 | |
| Kanuma® | sebelipase alfa | Alexion | lysosomal acid lipase (LAL) deficiency (Wolman disease; cholesteryl ester storage disease [CESD]) | 2015/12/08 | 44:00 - Enzymes | 1O | |
| Vistogard® | uridine triacetate | Wellstat | overdosage/toxicity of fluorouracil or capecitabine | 2015/12/11 | 92:12 - Antidotes | ||
| Alecensa® | alectinib | Hoffman-LaRoche | anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) | 2015/12/11 | 10:00 - Antineoplastic Agents | 1 | |
| Bridion® | sugammadex | Organon | reversal of neuromuscular blockade induced by rocuronium/vecuronium | 2015/12/14 | 92:12 - Antidotes | 1 | |
| Uptravi® | selexipag | Actelion | pulmonary arterial hypertension (PAH) | 2015/12/21 | 48:48 - Vasodilating Agents | 1S,O | |
| Zurampic® | lesinurad | Ardea | hyperuricemia associated with gout in combination with an XOI | 2015/12/22 | 92:16 - Antigout Agents | 1S |
| AHFS Class | Change Date | Change Description |
|---|---|---|
| 36:46 - Lymphatic System | 2015/01/29 | New subclass |
| 48:02 - Antifibrotic Agents | 2015/09/29 | New subclass |
| 20:28.92 - Antihemorrhagic Agents, Misc | 2015/10/20 | New subclass |
| 24:06.24 - Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Inhibitors | 2015/11/04 | New subclass |
| Drug Name(s) | Active Ingred | Change Date |
Old AHFS Class | New AHFS Class |
|---|---|---|---|---|
| Zerbaxa® | ceftolozane; tazobactam | 2015/01/13 | 8:12.06.16 - Fourth Generation Cephalosporins; — | 8:12.06.12 - Third Generation Cephalosporins; — |
| Ofev® | nintedanib | 2015/09/29 | 48:92 - Respiratory Tract Agents, Miscellaneous | 48:02 - Antifibrotic Agents |
| Esbriet® | pirfenidone | 2015/09/29 | 48:92 - Respiratory Tract Agents, Miscellaneous | 48:02 - Antifibrotic Agents |
| Praluent® | alirocumab | 2015/11/04 | 24:06.92 - Antilipemic Agents, Miscellaneous | 24:06.24 - Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Inhibitors |
| Repatha® | evolocumab | 2015/11/04 | 24:06.92 - Antilipemic Agents, Miscellaneous | 24:06.24 - Proprotein Convertase Subtilisin Kexin Type 9 (PCSK9) Inhibitors |