| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| Farxiga® | dapagliflozin | BMS | type 2 diabetes mellitus | 2014/01/08 | 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor | 1S | 202293 |
| Hetlioz® | tasimelteon | Vanda | non-24-hour sleep-wake disorder | 2014/01/31 | 28:24.92 - Anxiolytics, Sedatives, and Hypnotics, Misc. | 1 | |
| Imbruvica® | ibrutinib | Pharmacyclics | mantle cell lymphoma | 2014/02/12 | 10:00 - Antineoplastic Agents | 1P | |
| Vimizim® | elosulfase alfa | Biomarin | mucopolysaccharidosis type IVA (MPS IVA; Morquio A syndrome) | 2014/02/14 | 44:00 - Enzymes | ||
| Northera® | droxidopa | Chelsea Therapeutics | neurogenic orthostatic hypotension | 2014/02/18 | 12:12.12 - α- and β-Adrenergic Agonists | 1 | |
| Myalept® | metreleptin | Amylan | leptin deficiency in congenital or acquired generalized lipodystrophy | 2014/02/24 | 68:40 - Leptins (New) | ||
| Tivorbex® | indomethacin | Iroko | mild to moderate acute pain | 2014/02/24 | 28:08.04.92 - Other Nonsteroidal Anti-inflammatory Agents | 3 | |
| Neuraceq® | florbetaben | Primal Imaging | PET imaging of the brain | 2014/03/19 | 36:68 - Roentgenography | 1 | |
| Impavido® | miltefosine | Paladin Therapeutics | visceral, cutaneous, and mucosal leishmaniasis | 2014/03/19 | 8:30.92 - Antiprotozoals, Misc | 1 | |
| Otezla® Oral | apremilast | Celgene | psoriatic arthritis | 2014/03/21 | 92:36 - Disease-modifying Antirheumatic Drugs (DMARDs) | 1 | |
| Alprolix® | Coagulation Factor IX (Recombinant), Fc Fusion Protein | Biogen Idec | control and prevention of bleeding episode in patients with hemophilia B | 2014/03/28 | 20:28.16 - Hemostatics | ||
| Oralair® | grass pollen allergen extract (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) | Stallergenes | allergic rhinitis | 2014/04/02 | 92:92 - Other Miscellaneous Therapeutic Agents (moved to 80:02 - Allergenic Extracts) | ||
| Evzio® | naloxone | Kaleo | emergency treatment of opioid overdose | 2014/04/03 | 28:10 - Opiate Antagonists | 3 | |
| Grastek® | grass pollen allergen extract (Timothy Grass Pollen Allergen Extract) | MSD | allergic rhinitis | 2014/04/11 | 92:92 - Other Miscellaneous Therapeutic Agents (moved to 80:02 - Allergenic Extracts) | ||
| Tanzeum® | albiglutide | GlaxoSmithKline | type 2 diabetes mellitus | 2014/04/15 | 68:20.06 - Incretin Mimetics | ||
| Ragwitek® | short ragweed pollen allergen extract | MSD | allergic rhinitis | 2014/04/17 | 92:92 - Other Miscellaneous Therapeutic Agents (moved to 80:02 - Allergenic Extracts) | ||
| Cyramza® | ramucirumab | Eli Lilly | gastric cancer | 2014/04/21 | 10:00 - Antineoplastic Agents | ||
| Sylvant® | siltuximab | Janssen | multicentric Castleman's disease (MCD) | 2014/04/22 | 10:00 - Antineoplastic Agents | ||
| Chemet® | succimer | Recordati | lead poisoning | 2014/04/23 | 64:00 - Heavy Metal Antagonists | 1P,O | |
| Omtryg® | omega-3 acid ethyl esters | Trygg Pharma | hypertriglyceridemia | 2014/04/23 | 24:06.92 - Antilipemic Agents, Misc | 5 | |
| Zykadia® | ceritinib | Novartis | late-stage (metastatic) non-small cell lung cancer (NSCLC) | 2014/04/29 | 10:00 - Antineoplastic Agents | 5 | |
| Incruse Ellipta® | umeclidinium | GlaxoSmithKline | chronic obstructive pulminary disorder (COPD) | 2014/04/30 | 12:08.08 - Antimuscarinics/ Antispasmodics | 5 | |
| Epanova® | omega-3 carboxylic acids | AstraZeneca | hypertriglyceridemia | 2014/05/05 | 24:06.92 - Antilipemic Agents, Misc | 5 | |
| Zontivity® | vorapaxar | Merck | reduce the risk of heart attack, stroke, cardiovascular death | 2014/05/08 | 20:12.18 - Platelet-aggregation Inhibitors | 1 | |
| Izba® | travoprost | Alcon | open-angle glaucoma or ocular hypertension | 2014/05/15 | 52:40.28 - Prostaglandin Analogs | 5 | |
| Entyvio® | vedolizumab | Takeda | ulcerative colitis; Crohn's Disease | 2014/05/19 | 56:92 - GI Drugs, Miscellaneous | 1 | |
| Dalvance® | dalbavancin | Durata | acute bacterial skin infections caused by Gram+ organisms | 2014/05/23 | 8:12.28.16 - Glycopeptides | 1 | |
| Natesto® | testosterone | Trimel Biopharma | testosterone replacement therapy | 2014/05/28 | 68:08 - Androgens | 5S | |
| Omidria® | phenylephrine; ketorolac | Omeros | prevent intraoperative miosis and reduce postoperative pain during cataract surgery or intraocular lens replacement | 2014/05/30 | 52:24 - Mydriatics; 52:08.20 - Nonsteroidal Anti-inflammatory Agents | 4S | |
| Jublia® | efinaconazole | Dow | onchomycosis of the toenails | 2014/06/06 | 84:04.08.08 - Azoles | 1 | |
| Eloctate® | Antihemophilic Factor (Recombinant), Fc Fusion Protein | Biogen Idec | hemophilia A; treatment and prophylaxis of bleeding episodes | 2014/06/06 | 20:28.16 - Hemostatics | 1 | |
| Bunavail® | buprenorphine; naloxone | Biodelivery Sciences | maintenance treatment of opioid dependence | 2014/06/06 | 28:08.12 - Opiate Partial Agonists | 3S | |
| Sivextro® | tedizolid | Cubist | acute bacterial skin and skin structure infections | 2014/06/20 | 8:12.28.24 - Oxazolidinones | 1 | |
| Afrezza® | insulin recombinant human inhalation powder | Sanofi Aventis | diabetes mellitus | 2014/06/27 | 68:20.08 - Insulins | 5S | |
| Beleodaq® | belinostat | Spectrum | peripheral T-cell lymphoma (PTCL) | 2014/07/03 | 10:00 - Antineoplastic Agents | 1 | |
| Kerydin® | tavaborole | Anacor | onychomycosis (nail fungus) | 2014/07/07 | 84:04.08.24 - Oxaboroles (New) | 1 | |
| Zydelig® | idelalisib | Gilead | chronic lymphocytic leukemia (CLL); relapsed follicular B-cell non-Hodgkin lymphoma (FL); relapsed small lymphocytic lymphoma (SLL) | 2014/07/23 | 10:00 - Antineoplastic Agents | 1 | |
| Striverdi® | olodaterol | Boehringer Ingelheim | chronic obstructive pulmonary disease(COPD), including chronic bronchitis and/or emphysema | 2014/07/31 | 12:12.08.12 - Selective β2-Adrenergic Agonists | 1 | |
| Jardiance® | empagliflozin | Boehringer Ingelheim | type 2 diabetes mellitus | 2014/08/01 | 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitor | 1S | |
| Orbactiv® | oritavancin | Medicines Co | acute bacterial skin and skin structure infections (ABSSSI) | 2014/08/06 | 8:12.28.16 - Glycopeptides | 1S | |
| Invokamet® | canagliflozin; metformin | Janssen | type 2 diabetes mellitus | 2014/08/08 | 68:20.18 - SGLT2 Inhibitors; 68:20.04 - Biguanides | 1S | |
| Belsomra® | suvorexant | Merck | insomnia | 2014/08/13 | 28:24.92 - Anxiolytics, Sedatives, and Hypnotics; Miscellaneous | 1S | |
| Cerdelga® | eliglustat | Genzyme | type 1 Gaucher disease | 2014/08/19 | 92:92 - Other Miscellaneous Therapeutic Agents | ||
| Arnuity Ellipta® | fluticasone | GlaxoSmithKline | asthma | 2014/08/20 | 68:04 - Adrenals | 5S | |
| Triumeq® | abacavir; dolutegravir; lamivudine | Viiv | HIV infection | 2014/08/22 | 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NNRTI); 8:18.08.12 - HIV Integrase Inhibitors; 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NNRTI) | 4S | |
| Keytruda® | pembrolizumab | MSD | metastatic melanoma | 2014/09/04 | 10:00 - Antineoplastic Agents | 1 | |
| Zerenex® | ferric citrate | Keryx | hyperphosphatemia | 2014/09/05 | 40:18.19 - Phosphate-removing Agents | 5 | |
| Emsam® | selegiline | Somerset | depression | 2014/09/10 | 28:36.32 - Monoamine Oxidase B Inhibitors | 6S | |
| Contrave® | naltrexone; bupropion | Orexigen | chronic weight management | 2014/09/10 | 28:20.08.92 - Anorexigenic Agents, Miscellaneous | 4 | |
| Setlakin® | ethinyl estradiol; levonorgestrel | Novast | birth control | 2014/09/15 | 68:12 - Contraceptives | ||
| Movantik® | naloxegol | AstraZeneca | opioid-induced constipation (OIC) | 2014/09/16 | 56:92 - GI Drugs, Miscellaneous | 1P | |
| Trulicity® | dulaglutide | Eli Lilly | type 2 diabetes mellitus | 2014/09/18 | 68:20.06 - Incretin Mimetics | 1 | |
| Otezla® Injectable | apremilast | Celgene | psoriatic arthritis | 2014/09/23 | 92:36 - Disease-modifying Antirheumatic Drugs (DMARDs) | 1 | |
| Vitekta® | elvitegravir | Gilead | human immunodeficiency virus type 1 (HIV-1) infection | 2014/09/24 | 8:18.08.12 - HIV Integrase Inhibitors | 5 | |
| Tybost® | cobicistat | Gilead | pharmacologic enhancer to decrease metabolism, and increase plasma concentrations, of antiretroviral agents | 2014/09/24 | 92:92 - Other Miscellaneous Therapeutic Agents | 5 | |
| Iluvien® | fluocinolone acetonide intravitreal implant | Alimera | diabetic macular edema | 2014/09/24 | 52:08.08 - Corticosteroids | 3 | |
| Mitigare® | colchicine | Hikma | prophylaxis of gout flares | 2014/09/26 | 92:16 - Antigout Agents | 3 | |
| Uceris® | budesonide rectal foam | Salix | ulcerative colitis | 2014/10/07 | 68:04 - Adrenals | 3S | |
| Lumason® | sulfur hexafluoride lipid-type A microspheres | Bracco | echocardiograms | 2014/10/10 | 36:68 - Roentgenography | 1S | |
| Akynzeo® | netupitant; palonosetron | Helsinn | prevention of acute and delayed nausea and vomiting due to highly emetogenic chemotherapy | 2014/10/10 | 56:22.92 - Antiemetics, Misc; 56:22.20 - 5-HT3-receptor Antagonists | 1S | |
| Harvoni® | ledipasvir; sofosbuvir | Gilead | Hepatitis C virus infection | 2014/10/10 | 8:18.40.24 - HCV Replication Complex Inhibitors; 8:18.40.16 - HCV Polymerase Inhibitors | 1P | |
| Ofev® | nintedanib | Boehringer Ingelheim | idiopathic pulmonary fibrosis (IPF) | 2014/10/15 | 48:92 - Respiratory Agents, Miscellaneous | 1 | |
| Esbriet® | pirfenidone | InterMune (Roche) | idiopathic pulmonary fibrosis (IPF) | 2014/10/15 | 48:92 - Respiratory Agents, Miscellaneous | 1 | |
| Sotylize® | sotalol oral solution | Arbor | ventricular arrhythmias; atrial fibrillation/flutter | 2014/10/22 | 24:24 - β-Adrenergic Blocking Agents | 3S | |
| Obizur® | antihemophilic factor (recombinant), porcine sequence | Baxter | acquired hemophilia A (acquired Factor VIII [FVII] deficiency) | 2014/10/24 | 20:28.16 - Hemostatics | ||
| Trumenba® | Meningococcal Group B Vaccine | Wyeth | immunization against serogroup B meningococcal disease | 2014/10/29 | 80:12 - Vaccines | ||
| Xigduo XR® | dapagliflozin/metformin | AstraZeneca | type 2 diabetes mellitus | 2014/10/29 | 68:20.18 - SGLT2 Inhibitors; 68:20.04 - Biguanides | 4S | |
| Lemtrada® | alemtuzumab | Genzyme | multiple sclerosis | 2014/11/04 | 92:20 - Immunomodulatory Agents | ||
| Obredon® | hydrocodone/guaifenesin oral solution | Sovereign | symptomatic relief of cough and to loosen mucous associated with the common cold | 2014/11/14 | 48:08 - Antitussives; 48:16 - Expectorants | 4 | |
| Yaela® | drospirenone; ethinyl estradiol | Novast | birth control | 2014/11/19 | 68:12 - Contraceptives | ||
| Hysingla ER® | hydrocodone bitartrate | Purdue | severe, around-the-clock, pain management | 2014/11/20 | 28:08.08 - Opiate Agonists | 3 | |
| TrezixTM | acetaminophen; caffeine; dihydrocodeine | Wraser | moderate to moderately severe pain | 2014/11/26 | 28:08.92 - Analgesics and Antipyretics, Misc; 28:20.32 - Respiratory and CNS Stimulants; 28:08.08 - Opiate Agonists | ||
| Blincyto® | blinatumomab | Amgen | Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) | 2014/12/03 | 10:00 - Antineoplastic Agents | 1 | |
| Signifor LAR® | pasireotide | Novartis | acromegaly | 2014/12/15 | 68:29.04 - Somatostatin Agonists | 5S | |
| Xtoro® | finafloxacin | Alcon | acute otitis externa | 2014/12/17 | 52:04.04 - Antibacterials (EENT) | 1P | |
| Lynparza® | olaparib | AstraZeneca | advanced ovarian cancer | 2014/12/19 | 10:00 - Antineoplastic Agents | 1P | |
| Soolantra® | ivermectin | Galderma | rosacea | 2014/12/19 | 84:04.12 - Scabicides and Pediculisides | 1 | |
| Rapivab® | peramivir | BioCryst | influenza | 2014/12/19 | 8:18.28 - Neuraminidase Inhibitors | 1S | |
| Viekira Pak® | ombitasvir/ paritaprevir/ ritonavir; dasabuvir | Abbvie | genotype 1 chronic hepatitis C virus (HCV) infection | 2014/12/19 | 8:18.40.24 - HCV Replication Complex Inhibitors; 8:18.40.20 - HCV Protease Inhibitors; —; 8:18.40.16 - HCV Polymerase Inhibitors | 4P | |
| Zerbaxa® | ceftolozane/ tazobactam | Cubist | complicated intra-abdominal infections and urinary tract infections | 2014/12/19 | 8:12.06.12 - Third Generation Cephalosporins; — (previously posted as 4th Gen) | 4 | |
| Opdivo® | nivolumab | BMS | unresectable or metastatic melanoma and disease progression following ipilimumab treatment; metastatic squamous non-small cell lung cancer | 2014/12/22 | 10:00 - Antineoplastic Agents | - | |
| Dyloject® | diclofenac sodium | Javelin | intravenous NSAID; acute moderate-to-severe pain in adults | 2014/12/23 | 28:08.04.92 - Other Non-steroidal Anti-inflammatory Drugs | 3 | |
| Saxenda® | liraglutide | Novo Nordisk | chronic weight management | 2014/12/23 | 68:20.06 - Incretin Mimetics | 10S | |
| Namzaric® | memantine/ donepezil | Forest | Alzheimer's disease | 2014/12/23 | 28:92 - Central Nervous System Agents, Misc; 12:04 - Parasympathomimetic (Cholinergic) Agents | 4 |
| AHFS Class | Change Date | Change Description |
|---|---|---|
| 8:18.40 - HCV Antivirals | 2014/04/25 | Name change from "HCV Protease Inhibitors" to "HCV Antivirals" |
| 8:18.40.16 - HCV Polymerase Inhibitors | 2014/04/25 | New classification |
| 8:18.40.20 - HCV Protease Inhibitors | 2014/04/25 | New classification |
| 68:40 - Leptins | 2014/03/05 | New classification |
| 8:18.08.12 - HIV Integrase Inhibitors | 2014/04/25 | Name change; added "HIV" |
| 8:18.08.16 - HIV Nonnucleoside Reverse Transcriptase Inhibitors | 2014/04/25 | Name change; added "HIV" |
| 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors | 2014/04/25 | Name change; added "HIV" |
| 84:04.08.24 - Oxaboroles | 2014/07/09 | New classification |
| 28:20.08.92 - Anorexigenic Agents, Miscellaneous | 2014/09/10 | New classification |
| 36:06 - Allergenic Extracts | 2014/11/11 | New classification; products for diagnostic purposes go under this class; products for therapeutic purposes go under 80:02 |
| Drug Name(s) | Active Ingred | Change Date |
Old AHFS Class | New AHFS Class |
|---|---|---|---|---|
| Incivek® | telaprevir | 2014/04/25 | 8:18.40 - HCV Antivirals | 8:18.40.20 - HCV Protease Inhibitors |
| Olysio® | simeprevir | 2014/04/25 | 8:18.40 - HCV Antivirals | 8:18.40.20 - HCV Protease Inhibitors |
| Solvaldi® | sofosbuvir | 2014/04/25 | 8:18.32 - Nucleosides and Nucleotides | 8:18.40.16 - HCV Polymerase Inhibitors |
| Victrelis® | boceprevir | 2014/04/25 | 8:18.40 - HCV Antivirals | 8:18.40.20 - HCV Protease Inhibitors |
| Letairis® | ambrisentan | 2014/05/01 | 24:12.92 - Vasodilating Agents, Misc | 48:48 - Vasodilating Agents |
| Tracleer® | bosentan | 2014/05/01 | 24:12.92 - Vasodilating Agents, Misc | 48:48 - Vasodilating Agents |
| Flolan® | epoprostenol | 2014/05/01 | 24:12.92 - Vasodilating Agents, Misc | 48:48 - Vasodilating Agents |
| Ventavis® | iloprost | 2014/05/01 | 24:12.92 - Vasodilating Agents, Misc | 48:48 - Vasodilating Agents |
| Opsumit® | macitentan | 2014/05/01 | 24:12.92 - Vasodilating Agents, Misc | 48:48 - Vasodilating Agents |
| Adempas® | riociguat | 2014/05/01 | 24:12.92 - Vasodilating Agents, Misc | 48:48 - Vasodilating Agents |
| Orenitram®, Remodulin®, Tyvaso® | treprostinil | 2014/05/01 | 24:12.92 - Vasodilating Agents, Misc | 48:48 - Vasodilating Agents |
| Hyperstat®, Proglycem® | diazoxide | 2014/10/01 | 24:08.20 - Direct Vasodilators (injectable form for hypertension discontinued) | 68:22.92 - Antihypoglycemic Agents, Misc |