| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| E-Z-HD® Readi-Cat 2® |
barium sulfate | Bracco | double-contrast radiographic examinations of the esophagus, stomach and duodenum to visualize the GI tract | 2016/01/11 | 36:68 - Roentgenography | 1P | 208036 |
| Dexilant® Solutab | dexlansoprazole | Takeda | maintain healting of erosive esophagitis (EE); heartburn associated with non-erosive gastroesophageal reflux disease (GERD) | 2016/01/26 | 56:28.36 - Proton-pump Inhibitors | 3 | 208056 |
| Onzetra Xsail® | sumatriptan | Avanir | acute treatment of migraine with or without aura | 2016/01/27 | 28:32.28 - Selective Serotonin Agonists | 3 | 206099 |
| Adzenys XR-ODT® (CII) | amphetamine | Neos | attention deficit hyperactivity disorder (ADHD) | 2016/01/28 | 28:20.04 - Amphetamines | 3 | 204326 |
| Zembrace Symtouch® | sumatriptan | Dr Reddys | acute treatment of migraine with or without aura | 2016/01/28 | 28:32.28 - Selective Serotonin Agonists | 5 | 208223 |
| Zepatier® | elbasvir; grazoprevir | MSD | hepatitis C virus infection | 2016/01/28 | 8:18.40.24 - HCV Replication Complex Inhibitors; 8:18.40.20 - HCV Protease Inhibitors | 4 | 208261 |
| Cetylev® | acetylcysteine | Arbor | acetaminophen overdose/toxicity | 2016/01/29 | 92:12 - Antidotes | 3 | 207916 |
| Sernivo® | betamethasone dipropionate topical spray | Promius | mild to moderate plaque psoriasis | 2016/02/05 | 84:06 - Anti-inflammatory Agents | 3S | 208079 |
| Briviact® | brivaracetam | UCB | adjunctive therapy in the treatment of partial-onset seizures | 2016/02/18 | 28:12.92 - Anticonvulsants, Misc | 1S | 205836, 205837, 205838 |
| Xeljanz® XR | tofacitinib | Pfizer | rheumatoid arthritis | 2016/02/23 | 92:36 - Disease-modifying Antirheumatic Agents | 3S | 208246 |
| Odefsey® | emtricitabine; rilpivirine; tenofovir alafenamide (TAF) | Gilead | HIV-1 infection | 2016/03/01 | 8:18.08.20 - HIV NRTI; 8:18.08.16 - HIV NNRTI; 8:18.08.20 - HIV NRTI | 4 | 208351 |
| Idelvion® | coagulation factor IX (recombinant), albumin fusion protein (rIX-FP) (albutrepenonacog alfa) | CSL Behring | hemophilia B (congenital Factor IX deficiency) | 2016/03/04 | 20:28.16 - Hemostatics | 125582 | |
| Evomela® | melphalan | Spectrum | high-dose conditioning treatment prior to stem cell transplantation in multiple myeloma; palliative treatment of multiple myeloma when oral therapy is not appropriate | 2016/03/10 | 10:00 - Antineoplastic Agents | 5S | 207155 |
| Kovaltry® | antihemophilic factor, recombinant | Bayer | hemophilia A (congenital factor VIII deficiency) | 2016/03/17 | 20:28.16 - Hemostatics | 125574 | |
| Anthim® | obiltoxaximab | Elusys | treatment of inhalational anthrax; prophylaxis when alternative therapies not available (for national stockpile) | 2016/03/18 | 80:04 - Antitoxins and Immune Globulins | 125509 | |
| Taltz® | ixekizumab | Eli Lilly | moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy | 2016/03/22 | 84:92 - Skin and Mucous Membrane Agents, Misc | 125521 | |
| Cinqair® | reslizumab | Teva | severe asthma with an eosinophilic phenotype | 2016/03/23 | 48:10.20 - Interleukin Antagonists (updated 2016/04/20); originally posted as 48:92 - Respiratory Agents, Misc | 761033 | |
| Defitelio® | defibrotide | Gentium/Jazz | hepatic veno-occlusive disease (VOD) | 2016/03/30 | 20:12.92 - Antithrombotic Agents, Misc (new) | 1P | 208114 |
| Inflectra® | infliximab-dyyb | Celltrion | Crohn's Disease | 2016/04/05 | 92:36 - Disease-modifying Antirheumatic Drugs | 125544 | |
| Descovy® | emtricitabine; tenofovir alafenamide (TAF) | Gilead | HIV-1 infection | 2016/04/04 | 8:18.08.20 - HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) | 208215 | |
| Venclexta® | venetoclax | Abbvie | chronic lymphocytic leukemia (CLL) | 2016/04/11 | 10:00 - Antineoplastic Agents | P,O | 208573 |
| Bevespi® Aerosphere | glycopyrrolate; formoterol | Pearl | long-term maintenance treatment of COPD | 2016/04/25 | 12:08.08 - Antimuscarinics/ Antispasmodics; 12:12.08.12 - Selective beta-2-Adrenergic Agonists | 4 | 208294 |
| Cabometyx® | cabozantinib (s)-malate | Exelixis | advanced renal cell carcinoma (RCC) who have received prior antiangiogenic therapy | 2016/04/25 | 10:00 - Antineoplastic Agents | 208692 | |
| Xtampza® ER | oxycodone | Collegium | severe pain requiring around-the-clock treatment | 2016/04/26 | 28:08.08 - Opiate Agonists | 5 | 208090 |
| Acticlate® Capsules | doxycycline hyclate | Aqua | rickettsial infections, STDs, RTIs, anthrax; adjunctive therapy for intestinal amebiasis and severe acne; prophylaxis of malaria | 2016/04/26 | 8:12.24 - Tetracyclines | 5 | 208253 |
| Nuplazid® | pimavanserin | Acadia | hallucinations and delusions associated with Parkinson's disease psychosis | 2016/04/29 | 28:16.08.04 - Atypical Antipsychotics | 1P | 207318 |
| Otovel® Otic | ciprofloxacin; fluocinolone acetonide | Laboratorios Salvat SA | acute otitis media with tympanostomy tubes (AOMT) | 2016/04/29 | 52:04.04 - EENT Antibacterials; 52:08.08 - EENT Corticosteroids | 5 | 208251 |
| Akovaz® | ephedrine sulfate | Flamel Ireland | clinically important hypotension occurring in the setting of anesthesia | 2016/04/29 | 12:12.12 - alpha- and beta-Adrenergic Agonists | 7 | 208289 |
| Ameluz® 10% Gel | aminolevulinic acid | Biofrontera | actinic keratoses | 2016/05/10 | 84:92 - Skin and Mucous Membrane Agents, Misc | 3S | 208081 |
| Tecentriq® | atezolizumab | Genentech | locally advanced or metastatic urothelial carcinoma | 2016/05/18 | 10:00 - Antineoplastic Agents | 761034 | |
| Probuphine® Implant | buprenorphine | Titan | opioid dependence | 2016/05/26 | 28:08.12 - Opiate Partial Agonists | 3 | 204442 |
| Axumin® | fluciclovine (18F) | Blue Earth Diagnostics | radioactive diagnostic agent (prostate cancer) for PET imaging | 2016/05/27 | 36:68 - Roentgenography | 1 | 208054 |
| Zinbryta® | daclizumab | Biogen | multiple sclerosis | 2016/05/27 | 92:20 - Immunomodulatory Agents | 761029 | |
| Ocaliva® | obeticholic acid | Intercept | primary biliary cholangitis (PBC) | 2016/05/27 | 56:92 - GI Drugs, Misc | 1 | 207999 |
| Netspot® | gallium (Ga 68) dotatate | Advanced Accelerator | radioactive diagnostic agent (somatostatin receptor positive neuroendocrine tumors (NETs)) for PET imaging | 2016/06/01 | 36:68 - Roentgenography | 1 | 208547 |
| Byvalson® | nebivolol; valsartan | Forest Labs | hypertension | 2016/06/03 | 24:24 - β-Adrenergic Blocking Agents; 24:32.08 - Angiotensin II Receptor Antagonists | 4 | 206302 |
| Vaxchora® | cholera vaccine live oral | Pax Vax | active immunization against Vibrio cholerae serogroup O1 | 2016/06/10 | 80:12 - Vaccines | 125597 | |
| Rayaldee® | calcifediol | Opko | secondary hyperparathyroidism with chronic kidney disease (CKD) | 2016/06/17 | 88:16 - Vitamin D | 5 | 208010 |
| Epclusa® | sofosbuvir; velpatasivir | Gilead | hepatitis C virus infection | 2016/06/28 | 8:18.40.16 - HCV Polymerase Inhibitors; 8:18.40.24 - HCV Replication Complex Inhibitors | 1P | 208341 |
| Kovanaze® | tetracaine; oxymetazoline | St Renatus | regional anesthesia for dental procedures | 2016/06/29 | 52:16 - Local Anesthetics (EENT); 52:32 - Vasoconstrictors (EENT) | 4S | 208032 |
| Syndros® | dronabinol | Insys | treatment of AIDS-related weight loss; chemotherapy-induced nausea/vomiting | 2016/07/01 | 56:22.92 - Antiemetics, Misc | 3S | 205525 |
| Xiidra® | lifitegrast | Shire | dry eye disease | 2016/07/11 | 52:08.92 - Anti-inflammatory Agents, Misc | 1P | 208073 |
| SMOF Lipid® | SMOF (soybean oil, medium-chain triglycerides, olive oil, fish oil) | Fresenius Kabi | parenteral caloric replacement | 2016/07/13 | 40:20 - Caloric Agents | 4 | 207648 |
| Photrexa®, Photrexa® Viscous | riboflavin 5'-phosphate | Avedro | for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery | 2016/07/15 | 52:92 - EENT Drugs, Misc | 3P | 203324 |
| Belviq XR® | lorcaserin | Arena | adjunct to a reduced-calorie diet and increased physical activity for chronic weight management | 2016/07/15 | 28:20.08.32 - Selective Serotonin Receptor Agonists | 5 | 208524 |
| Viekira XR® | dasabuvir; ombitasvir; paritaprevir; ritonavir | Abbvie | chronic hepatitis C virus (HCV) infection | 2016/07/22 | 8:18.40.16 - HCV Polymerase Inhibitors; 8:18.40.24 - HCV Replication Complex Inhibitors; 8:18.40.20 - HCV Protease Inhibitors | 3 | 208624 |
| Adlyxin® | lixisenatide | Sanofi-Aventis | type 2 diabetes mellitus | 2016/07/27 | 68:20.06 - Incretin Mimetics | 1 | 208471 |
| Qbrelis® | lisinopril | Silvergate | hypertension; adjunct therapy for heart failure; acute myocardial infarction | 2016/07/29 | 24:32.04 - Angiotensin-Converting Enzyme Inhibitors | 3S | 208401 |
| Sustol® | granisetron | Heron | prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic chemotherapy (MEC) or anthracycline and cyclophosphamide (AC) combination chemotherapy regimens | 2016/08/09 | 56:22.20 - 5-HT3 Receptor Antagonists | 5 | 022445 |
| Troxyca ER® | oxycodone; naltrexone | Pfizer | severe pain | 2016/08/19 | 28:08.08 - Opiate Agonists; 28:10 - Opiate Antagonists | 4 | 207621 |
| Erelzi® | etanercept-szzs | Sandoz | rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, plaque psoriasis | 2016/08/30 | 92:36 - Disease-modifying Antirheumatic Drugs | 761042 | |
| Yosprala® | aspirin; omeprazole | Aralez | secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin-associated gastric ulcers | 2016/09/14 | 20:12.18 - Platelet-aggregation Inhibitors; 56:28.36 - Proton-pump Inhibitors | 205103 | |
| Kyleena® | levonorgestrel | Bayer | long-acting reversible contraceptive (LARC) (5 years) | 2016/09/16 | 68:12 - Contraceptives | 5 | 208224 |
| Exondys 51® | eteplirsen | Sarepta | Duchenne muscular dystrophy (DMD) with confirmed mutation of DMD gene that is amenable to exon 51 skipping | 2016/09/19 | 92:92 - Other Miscellaneous Therapeutic Agents | 1P | 206488 |
| Invokamet XR® | canagliflozin; metformin | Janssen | type 2 diabetes mellitus | 2016/09/20 | 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors; 68:20.04 - Biguanides | 4S | 205879 |
| Epaned® | enalapril | Silvergate | hypertension, heart failure, left ventricular dysfunction | 2016/09/20 | 24:32.04 - Angiotensin-Converting Enzyme Inhibitors | 5S | 208686 |
| Amjevita® | adalimumab-atto | Amgen | rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD), ulverative colitis (UC), plaque psoriasis (Ps) | 2016/09/23 | 92:36 - Disease-modifying Antirheumatic Drugs | 761024 | |
| CarnexIV® | carbamazepine | Lundbeck | seizures | 2016/10/07 | 28:12.92 - Anticonvulsants, Miscellaneous | 3 | |
| Tecentriq® | atezolizumab | Genentech | metastatic urothelial carcinoma; metastatic NSCLC | 2016/10/18 | 10:00 - Antineoplastic Agents | 761041 | |
| Lartruvo® | olaratumab | Eli Lilly | soft tissue sarcoma (STS) | 2016/10/19 | 10:00 - Antineoplastic Agents | 761038 | |
| Zinplava® | bezlotoxumab | MSD | in combination with antibacterial therapy to treat Clostridium difficile | 2016/10/21 | 80:04 - Antitoxins and Immune Globulins | 761046 | |
| Selzentry® Oral Solution | maraviroc | Viiv | HIV infection | 2016/11/04 | 8:18.08.04 - HIV Entry and Fusion Inhibitors | 3P | 208984 |
| Bonjesta® | doxylamine; pyridoxine | Duchesnay | nausea/vomiting due to pregnancy | 2016/11/07 | 56:22.08 - Antihistamines | 5S | 209661 |
| Vemlidy® | tenofovir alafenamide | Gilead | chronic hepatitis B virus infection (HBV) | 2016/11/10 | 8:18.32 - Nucleosides and Nucleotides | 5S | 208464 |
| Intrarosa® | prasterone | Gilead | moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause | 2016/11/16 | 68:04 - Adrenals | 2/4 | 208470 |
| Xultophy 100/3.6® | insulin degludec; liraglutide | Novo Nordisk | type 2 diabetes mellitus | 2016/11/21 | 68:20.08 - Insulins; 68:20.06 - Incretin Mimetics | 4S | 208583 |
| Soliqua 100/33® | insulin glargine; lixisenatide | Sanofi Aventis | type 2 diabetes mellitus | 2016/11/21 | 68:20.08 - Insulins; 68:20.06 - Incretin Mimetics | 4S | 208673 |
| Synjardy XR® | empagliflozin; metformin | Boehringer Ingelheim | type 2 diabetes mellitus | 2016/12/09 | 68:20.18 - SGLT2 Inhibitors; 68:20.04 - Biguanides | 3S | 208658 |
| Eucrisa® | crisaborole | Anacor | topical treatment of mild to moderate atopic dermatitis | 2016/12/14 | 84:06 - Anti-inflammatory Agents | 1S | 207695 |
| Tirosint-Sol® | levothyroxine sodium | IBSA | replacement therapy in congenital or acquired hypothyroidism; adjunct to surgery and radiation in management of thyrotropin-dependent well-differentiated thyroid cancer | 2016/12/15 | 68:36.04 - Thyroid Agents | 3S | 206977 |
| Rubraca® | rucaparib | Clovis | BRCA mutation associated advanced ovarian cancer | 2016/12/19 | 10:00 - Antineoplastic Agents | 1P | 209115 |
| Spinraza® | nusinersen | Biogen | spinal muscular atrophy (SMA) | 2016/12/23 | 92:92 - Other Miscellaneous Therapeutic Agents | 1P | 209531 |
| AHFS Class | Change Date | Change Description |
|---|---|---|
| 20:12.92 - Antithrombotic Agents, Misc | 2016/03/31 | New subclass |
| 48:10.20 - Interleukin Antagonists | 2016/04/20 | New subclass |
| 92:26 - Carbonic Anhydrase Inhibitors | 2016/05/13 | New subclass |
| 56:22.32 - Neurokinin-1 Receptor Antagonists | 2016/06/09 | New subclass |
| 80:00 - Antitoxins, Immune Globulins, Toxoids, and Vaccines | 2016/09/14 | Rename class from Serums, Toxoids, and Vaccines |
| 80:02 - Allergenic Extracts | 2016/09/14 | New subclass; products for therapeutic indications go here, products for diagnostic indications go under 36:06 |
| 80:04 - Antitoxins and Immune Globulins | 2016/09/14 | Rename class from Serums |
| Drug Name(s) | Active Ingred | Change Date |
Old AHFS Class | New AHFS Class |
|---|---|---|---|---|
| Cinqair® | reslizumab | 2016/04/20 | 48:92 - Respiratory Agents, Misc | 48:10.20 - Interleukin Antagonists |
| Firmagon® | degarelix | 2016/04/20 | 10:00 - Antineoplastic Agents | 10:00 - Antineoplastic Agents; 92:40 - Gonadotropin-releasing Hormone Antagonists |
| Keveyis® | dichlorphenamide | 2016/05/13 | 92:92 - Other Miscellaneous Therapeutic Agents | 92:26 - Carbonic Anhydrase Inhibitors |
| Emend® | Aprepitant/Fosaprepitant | 2016/06/09 | 56:22.92 - Antiemetics, Miscellaneous | 56:22.32 - Neurokinin-1 Receptor Antagonists |
| Akynzeo® | Netupitant | 2016/06/09 | 56:22.92 - Antiemetics, Miscellaneous | 56:22.32 - Neurokinin-1 Receptor Antagonists |
| Varubi® | Rolapitant | 2016/06/09 | 56:22.92 - Antiemetics, Miscellaneous | 56:22.32 - Neurokinin-1 Receptor Antagonists |
| raxibacumab | 2016/09/14 | 8:92 - Anti-infectives, Miscellaneous | 80:04 - Antitoxins and Immune Globulins | |
| Diclegis® | doxylamine; pyridoxine | 2016/11/07 | 56:22.92 - Antiemetics, Miscellaneous | 56:22.08 - Antihistamines |
| Zurampic® | lesinurad | 2016/11/17 | 92:16 - Antigout Agents | 40:40 - Uricosuric Agents (primary); 92:16 - Antigout Agents (secondary) |