| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| Skyla® | levonorgestrel | Bayer | birth control | 2013/01/09 | 68:12 - Contraceptives | 5 | 203159 |
| Uceris® | budesonide | Santarus | ulcerative colitis | 2013/01/14 | 68:04 - Adrenals | 5 | |
| Zecuity® | sumatriptan | Nupathe | migraine headache | 2013/01/17 | 28:32.28 - Selective Serotonin Agonists | 3 | |
| Nesina® | alogliptin | Takeda | type 2 diabetes mellitus | 2013/01/25 | 68:20.05 - DPP-4 Inhibitors | 1 | |
| Oseni® | alogliptin; pioglitazone | Takeda | type 2 diabetes mellitus | 2013/01/25 | 68:20.05 - DPP-4 Inhibitors; 68:20.28 - Thiazolidinediones | 1 | |
| Kazano® | alogliptin; metformin | Takeda | type 2 diabetes mellitus | 2013/01/25 | 68:20.05 - DPP-4 Inhibitors; 68:20.04 - Biguanides | 1 | |
| Kynamro® | mipomersen | Genzyme | homozygous familial hyper-cholesterolemia (HoFH) | 2013/01/29 | 24:06.92 - Antilipemic Agents, Miscellaneous | 1 | |
| Ravicti® | glycerol phenylbuterate | Hyperion | urea cycle disorders (UCDs) | 2013/02/01 | 40:10 - Ammonia Detoxicants | 1S | |
| Delzicol® | mesalamine | Warner Chilcott | ulcerative colitis | 2013/02/01 | 56:36 - Anti-inflammatory Agents | 3S | |
| Versacloz® | clozapine | Douglas | schizophrenia | 2013/02/06 | 28:16.08.04 - Atypical Antipsychotics | 3 | |
| Pomalyst® | pomalidomide | Celgene | multiple myeloma | 2013/02/08 | 10:00 - Antineoplastic Agents | 1 | |
| Kadcyla® | ado-trastuzumab emtansine | Genentech | metastatic HER2 breast cancer | 2013/02/22 | 10:00 - Antineoplastic Agents | 1 | |
| Stivarga® | regorafenib | Bayer | metastatic colorectal cancer | 2013/02/25 | 10:00 - Antineoplastic Agents | 1P | |
| Osphena® | ospemifene | Shionogi | menopausal dyspareunia | 2013/02/26 | 68:16.12 - Estrogen Agonists-Antagonists | 1S | |
| Enskyce™ | desogestrel; ethinyl estradiol | Lupin | birth control | 2013/03/07 | 68:12 - Contraceptives | ||
| Lymphoseek® | technetium Tc99 tilmanocept | Navidea | lymph node mapping | 2013/03/13 | 36:68 - Roentgenography | 1S | |
| Dotarem® | gadoterate meglumine | Guerbet | for use in MRIs of CNS | 2013/03/20 | 36:68 - Roentgenography | 1S | |
| botulism antitoxin heptavalent (equine) | Cangene | botulism | 2013/03/22 | 80:04 - Serums | 1 | ||
| Tecfidera® | dimethyl fumerate | Biogen Idec | multiple sclerosis | 2013/03/27 | 92:20 - Biologic Response Modifiers | 1 | |
| Karbinal® ER | carbinoxamine | Tris | seasonal and perennial allergic rhinitis; urticaria; angioedema | 2013/03/28 | 4:04 - First Generation Antihistamines | 3S | |
| Jencycla™ | norethindrone | Lupin | birth control | 2013/03/28 | 68:12 - Contraceptives | ||
| Quartette® | levonorgestrel; ethinyl estradiol | Teva | birth control | 2013/03/28 | 68:12 - Contraceptives | 5 | |
| Invokana® | canagliflozin | Janssen | type 2 diabetes | 2013/03/29 | 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors (New class) | 1 | |
| Prolensa® | bromfenac | Bausch+Lomb | postoperative pain and inflammation after cataract surgery | 2013/04/5 | 52:08.20 - Nonsteroidal Anti-inflammatory Agents | 5 | |
| Diclegis® | doxylamine; pyridoxine | Duchesnay | morning sickness | 2013/04/09 | 56:22.92 - Antiemetics, Misc | 4 | |
| Daysee™ | ethinyl estradiol; levonorgestrel | Lupin | birth control | 2013/04/10 | 68:12 - Contraceptives | 3 | |
| Sitavig® | acyclovir | Bioalliance | recurrent herpes labialis (cold sores) | 2013/04/12 | 84:04.06 - Antivirals | 3S | |
| Simbrinza® | brinzolamide; brimonidine | Alcon | open-angle glaucoma; ocular hypertension | 2013/04/19 | 52:40.04 - α-Adrenergic Agonists; 52:40.12 - Carbonic Anhydrase Inhibitors | 4 | |
| Minastrin® 24 FE | ethinyl estradiol; norethindrone; ferrous fumerate | Warner Chilcott | birth control | 2013/04/19 | 68:12 - Contraceptives | 3 | |
| Pirmella™ 7/7/7 & 1/35 | ethinyl estradiol; norethindrone | Lupin | birth control | 2013/04/24 | 68:12 - Contraceptives | 3 | |
| Kcentra® | prothrombin complex concentrate (human) | CSL Behring | urgent reversal of VKA (e.g., warfarin) in acute major bleeding episodes | 2013/04/29 | 20:28.16 - Hemostatics | ||
| Procysbi® | cysteamine bitartrate | Raptor | nephropathic cystinosis | 2013/04/30 | 92:92 - Other Misc Therapeutic Agents | 5 | |
| Breo Ellipta® | fluticasone / vilanterol | Glaxo | COPD | 2013/05/10 | 68:04 - Adrenals; 12:12.08.12 - Selective β2-Adrenergic Agonists | 1 | |
| Xofigo® | radium (Ra223) | Bayer | advanced prostate cancer with metastasis to bone | 2013/05/15 | 78:00 - Radioactive Agents | 1P | |
| Tafinlar® | dabrafenib | GSK | advanced or unresectable melanoma | 2013/05/29 | 10:00 - Antineoplastic Agents | 1 | |
| Mekinist® | trametinib | GSK | advanced or unresectable melanoma | 2013/05/29 | 10:00 - Antineoplastic Agents | 1 | |
| Brisdelle® | paroxetine | Noven | moderate to severe vasomotor symptoms associated with menopause | 2013/06/30 | 28:16.04.20 - Selective Serotonin-reuptake Inhibitors | 3 | |
| Zubsolv® | buprenorphine / naloxone | Orexo | maintenance treatment of opioid dependence | 2013/07/03 | 28:08.12 - Opiate Partial Agonists | 5 | |
| Khedezla® | desvenlafaxine | Osmotica | major depressive disorder | 2013/07/10 | 28:16.04.16 - Selective Serotonin- and Norepinephrine-reuptake Inhibitors | 5 | |
| Gilotrif® | afatinib | Boehringer Ingelheim | metastatic non-small cell lung cancer | 2013/07/12 | 10:00 - Antineoplastic Agents | 1 | |
| Injectafer® | ferric carboxymaltose | Luitpold | iron deficiency anemia | 2013/07/25 | 20:04.04 - Iron Preparations | 5 | |
| Fetzima® | levomilnacipran | Forest | major depressive disorder | 2013/07/25 | 28:16.04.16 - Selective Serotonin- and Norepinephrine-reuptake Inhibitors | 5 | |
| Tivicay® | dolutegravir | Viiv | HIV-1 infection | 2013/08/12 | 8:18.08.12 - Integrase Inhibitors | 1 | |
| Valchlor® | mechlorethamine | Ceptaris | fungoides-type cutaneous T-cell lymphoma | 2013/08/23 | 84:92 - Skin and Mucous Membrane Agents, Misc | 5S | |
| Mirvaso® | brimonidine | Galderma | facial erythema of rosacea | 2013/08/26 | 84:92 - Skin and Mucous Membrane Agents, Misc | 3 | |
| Brintellix® | vortioxetine | Takeda | major depressive disorder | 2013/09/30 | 28:16.04.24 - Serotonin Modulators | 1S | |
| Duavee® | conjugated estrogens / bazedoxifene | Wyeth | vasomotor symptoms associated with menopause | 2013/10/03 | 68:16.12 - Estrogen Agonists-Antagonists | 4 | |
| Clinolipid® | lipid | Baxter | parenteral nutrition | 2013/10/03 | 40:20 - Caloric Agents | 5 | |
| Adempas® | riociguat | Bayer | pulmonary hypertension (CTEPH / PAH) | 2013/10/08 | 24:12.92 - Vasodilating Agents, Misc | 1 | |
| Otrexup® | methotrexate | Antares | rheumatoid arthritis; psoriasis | 2013/10/11 | 92:36 - Disease-modifying Antirheumatic Drugs | 5S | |
| Opsumit® | macitentan | Actelion | pulmonary arterial hypertension | 2013/10/18 | 24:12.92 - Vasodilating Agents, Misc | 1 | |
| Zorvolex® | diclofenac | Iroko | mild to moderate acute pain | 2013/10/18 | 28:08.04.92 - Other Nonsteroidal Anti-inflammatory Agents | 3 | |
| Ecoza® | econazole | Amderma | interdigital tinea pedis | 2013/10/24 | 84:04.08.08 - Azoles | 3 | |
| Zohydro ER® | hydrocodone | Zogenix | severe pain | 2013/10/25 | 28:08.08 - Opiate Agonists | 3 | |
| Vizamyl® | flutemetamol F18 | GE Healthcare | PET imaging of the brain | 2013/10/25 | 36:68 - Roentgenography | 1S | |
| Gazyva® | obinutuzumab | Genentech | chronic lymphocytic leukemia (CLL) | 2013/11/01 | 10:00 - Antineoplastics | ||
| Aptiom® | eslicarbazepine | Sunovion | partial seizures | 2013/11/08 | 28:12.92 - Anticonvulsants, Misc | 1S | |
| Imbruvica® | ibrutinib | Pharmacyclics | mantle cell lymphoma (MCL) | 2013/11/13 | 10:00 - Antineoplastic Agents | 1 | |
| Luzu® | luliconazole | Medicis | interdigital tinea pedis, tinea cruris, tinea corporis | 2013/11/14 | 84:04.08.08 - Azoles | 1S | |
| Olysio® | simeprevir | Janssen | chronic hepatitis C infection | 2013/11/22 | 8:18.40 - HCV Protease Inhibitors | 1 | |
| influenza A (H5N1) virus monovalent vaccine | Sanofi Pasteur | avian influenza; for national stockpile only; no commercial products | 2013/11/22 | 80:12 - Vaccines | 1 | ||
| Varithena® | polidocanol | Provensis | varicose (spider and reticular) veins | 2013/11/25 | 24:16 - Sclerosing Agents | 5 | |
| Velphoro® | sucroferric oxyhydroxide | Vifor Fresenius | hyperphosphatemia in dialysized patients | 2013/11/27 | 40:18.19 - Phosphate-removing Agents | 5 | |
| Sovaldi® | sofosbuvir | Gilead | chronic hepatitis C (CHC) infection | 2013/12/06 | 8:18.32 - Nucleosides and Nucleotides | 1 | |
| Anoro Ellipta® | umeclidinium; vilanterol | Glaxo | chronic obstructive pulmonary disease (COPD) | 2013/12/18 | 12:08.08 - Antimuscarinics/ Antispasmodics; 12:12.08.12 - Selective β2-Adrenergic Agonists | 1 | |
| Kuvan® | sapropterin | Biomarin | hyperphenylalaninemia (HPA) | 2013/12/19 | 92:92 - Other Miscelaneous Therapeutic Agents | 3S;O | |
| Orenitram® | treprostinil diolamine | United Therapeutics | pulmonary arterial hypertension (PAH) | 2013/12/20 | 48:48 - Vasodilating Agents | 3S;O |
| AHFS Class | Change Date | Change Description |
|---|---|---|
| 28:20 - Anorexigenic Agents and Respiratory and CNS Stimulants | 2013/01/01 | Name Change |
| 28:20.08 - Anorexigenic Agents | 2013/01/01 | New classification |
| 28:20.08.04 - Amphetamine Derivatives | 2013/01/01 | New classification |
| 28:20.08.32 - Selective Serotonin Receptor Agonists | 2013/01/01 | New classification |
| 28:20.32 - Respiratory and CNS Stimulants | 2013/01/01 | New classification |
| 28:20.80 - Wakefulness-promoting Agents | 2013/01/01 | New classification |
| 28:20.92 - Anorexigenic Agents and Stimulants, Miscellaneous | 2013/01/01 | Name Change |
| 48:14 - Cystic Fibrosis Transmembrane Conductance Regulator Modulators | 2013/01/01 | New classification |
| 48:14.04 - Cystic Fibrosis Transmembrane Conductance Regulator Correctors | 2013/01/01 | New classification |
| 48:14.12 - Cystic Fibrosis Transmembrane Conductance Regulator Potentiators | 2013/01/01 | New classification |
| 68:20.18 - Sodium-glucose Cotransporter 2 (SGLT2) Inhibitors | 2013/04/03 | New classification |
| 86:12.04 - Antimuscarinics | 2013/07/01 | New classification |
| 86:12.08 - β3-Adrenergic Agonists | 2013/07/01 | New classification |
| 86:12.08.12 - Selective β3-Adrenergic Agonists | 2013/07/01 | New classification |
| 68:29 - Somatostatin Agonists and Antagonists | 2013/09/01 | New classification |
| 68:29.04 - Somatostatin Agonists | 2013/09/01 | New classification |
| 68:29.08 - Somatostatin Antagonists | 2013/09/01 | New classification |
| 92:20 - Immunomodulatory Agents | 2013/09/01 | Name change |
| Drug Name(s) | Active Ingred | Change Date |
Old AHFS Class | New AHFS Class |
|---|---|---|---|---|
| Tenuate® | diethylpropion | 2013/01/01 | 28:20.92 | 28:20.08.04 |
| Adipost®, Bontril® | phendimetrazine | 2013/01/01 | 28:20.92 | 28:20.08.04 |
| Adipex®, Ionamin® | phentermine | 2013/01/01 | 28:20.92 | 28:20.08.04 |
| Belviq® | lorcaserin | 2013/01/01 | 28:20.92 | 28:20.08.32 |
| Amoply® | ammonia spirit, aromatic | 2013/01/01 | 28:20.92 | 28:20.32 |
| Cafcit®, No Doz®, Vivarin® | caffeine/ caffeine and sodium benzoate | 2013/01/01 | 28:20.92 | 28:20.32 |
| Focalin® | dexmethylphenidate | 2013/01/01 | 28:20.92 | 28:20.32 |
| Dopram® | doxapram | 2013/01/01 | 28:20.92 | 28:20.32 |
| Concerta®, Daytrana®, Metadate®, Methylin®, Ritalin® | methylphenidate | 2013/01/01 | 28:20.92 | 28:20.32 |
| Nuvigil® | armodafinil | 2013/01/01 | 28:20.92 | 28:20.80 |
| Provigil® | modafinil | 2013/01/01 | 28:20.92 | 28:20.80 |
| Kalydeco® | ivacaftor | 2013/01/01 | 48:92 | 48:14.12 |
| Enablex® | darifenacin | 2013/07/01 | 86:12 | 86:12.04 |
| Toviaz® | fesoterodine | 2013/07/01 | 86:12 | 86:12.04 |
| Urispas® | flavoxate | 2013/07/01 | 86:12 | 86:12.04 |
| Ditropan®, Ditropan® XL, Gelnique®, Oxytrol® | oxybutynin | 2013/07/01 | 86:12 | 86:12.04 |
| Vesicare® | solifenacin | 2013/07/01 | 86:12 | 86:12.04 |
| Detrol®, Detrol® LA | tolterodine | 2013/07/01 | 86:12 | 86:12.04 |
| Sanctura®, Sanctura® XR | trospium | 2013/07/01 | 86:12 | 86:12.04 |
| Myrbetriq® | mirabegron | 2013/07/01 | 86:12 | 86:12.08.12 |
| Somatuline® Depot | lanreotide | 2013/09/01 | 92:92 | 68:29.04 |
| Signifor® | pasireotide | 2013/07/01 | 92:92 | 68:29.04 |
| Sandostatin® | octreotide | 2013/07/01 | 92:92 | 68:29.04; 56:92 |