| Drug Name | Active Ingred | Mfr | Indication | Approval Date |
AHFS Class | NDA Chem Type* |
Appl No |
|---|---|---|---|---|---|---|---|
| Natroba® | spinosad | Parapro | head lice infestations | 1/18/2011 | 84:04.12 - Scabicides and Pediculicides | ||
| Viibryd® | vilazodone | Forest | major depressive disorder | 1/21/2011 | 28:16.04.24 - Serotonin Modulators | ||
| Edarbi® | azilsartan | Takeda | hypertension | 2/25/2011 | 24:32.08 - Angiotensin II Receptor Antagonists | ||
| Daliresp® | roflumilast | Forest | severe COPD associated with chronic bronchitis | 2/28/2011 | See entry below on 9/27/11 | ||
| Benlysta® | belimumab | Human Genome Sciences | active, autoantibody-positive lupus (systemic lupus erythematosus) | 3/9/2011 | 92:44 - Immunosuppressive Agents | ||
| Gadavist® | gadobutrol | Bayer | diagnostic MRI | 3/14/2011 | 36:68 - Roentgenography | ||
| - | adenovirus Type 4 and Type 7 Vaccine, Live, Oral | Teva | prevention of febrile acute respiratory disease caused by Adenovirus Type 4 and Type 7 (military use only) | 3/17/2011 | 80:12 - Vaccines | ||
| Yervoy® | ipilimumab | BMS | unresectable or metastatic melanoma | 3/25/2011 | 10:00 - Antineoplastic Agents | ||
| Syeda® | drospirenone; ethinyl estradiol | Labs Leon | birth control | 3/28/2011 | 68:12 - Contraceptives | ||
| Zactima® | vandetanib | AstraZeneca | late-stage metastatic medullary thyroid cancer | 4/6/2011 | 10:00 - Antineoplastic Agents | ||
| Horizant® | gabapentin enacarbil | Xenoport | moderate-to-severe restless legs syndrome (RLS) | 4/6/2011 | 28:12.92 - Anticonvulsants, Misc; 28:08.92 - Analgesics and Antipyretics, Misc | ||
| Zytiga® | abiraterone acetate | Centocor Ortho Biotech | metastatic castration-resistant prostate cancer | 4/28/2011 | 10:00 - Antineoplastic Agents | ||
| Trajenta® | linagliptin | Lilly/Beohringer Ingelheim | type 2 diabetes | 5/2/2011 | 68:20.05 - Dipeptidyl Peptidase-4 (DPP-4) Inhibitors | ||
| Victrelis® | boceprevir | Schering | chronic hepatitis C genotype 1 | 5/13/2011 | 8:18.40 - HCV Protease Inhibitors (new class) | ||
| Edurant® | rilpivirine | Tibotec | HIV type 1 | 5/20/2011 | 8:18.08.16 - Non-nucleoside reverse transcriptase inhibitors | ||
| Incivek® | telaprevir | Vertex | chronic hepatitis C genotype 1 | 5/23/2011 | 8:18.40 - HCV Protease Inhibitors | ||
| Dificid® | fidaxomicin | Optimer | Clostridium difficile | 5/28/2011 | 8:12.12.92 - Other Macrolides | ||
| Potiga® | ezogabine | Valeant | partial seizures | 6/10/2011 | 28:12.92 - Anticonvulsants, Miscellaneous | ||
| Nulojix® | belatacept | BMS | prophylaxis of organ rejection in adult patients receiving a kidney transplant | 6/15/2011 | 92:44 - Immunosuppressive Agents | ||
| laVív® | azficel-T | Fibrocell Science | nasolabial fold wrinkles | 6/21/2011 | 26:00 - Cellular Therapy | ||
| Rectiv® | nitroglycerin | Prostrakan | moderate to severe pain assoc with chronic anal fissure | 6/21/2011 | 84:92 - Skin and Mucous Membrane Agents, Misc | ||
| Arcapta® | indacaterol | Novartis | COPD | 7/1/2011 | 12:12.08.12 - Selective beta-2-Adrenergic Agonists | ||
| Xarelto® | rivaroxaban | Johnson & Johnson | prophylaxis of deep vein thrombosis during knee/hip surgery | 7/1/2011 | 20.12.04.14 - Direct Factor Xa Inhibitors (new class) | ||
| Arixtra® | fondaparinux | GlaxoSmithKline | prophylaxis of deep vein thrombosis during knee/hip surgery | 7/1/2011 | from 20:12.04.92 to new class 20.12.04.14 - Direct Factor Xa Inhibitors | ||
| Brilinta® | ticagrelor | AstraZeneca | unstable angina, ST and non-ST elevation myocardial infarction | 7/20/2011 | 20:12.18 - Platelet-aggregation Inhibitors | ||
| Anascorp® | centruroides (scorpion) immune F(ab')2 (Equine) injection | RDT | scorpion envenomation | 8/3/2011 | 80:04 - Serums | ||
| Complera® | emtricitabine/ rilpivirine/ tenofovir | Gilead | HIV type 1 | 8/10/2011 | 8:18.08.16 - NNRTI, 8:18.08.20 - NRTI | ||
| Zelboraf® | vemurafenib | Hoffman-LaRoche | unresectable or metastatic melanoma with BRAFV600E mutation | 8/17/2011 | 10:00 - Antineoplastic Agents | ||
| Adcetris® | brentuximab | Seattle Genetics | Hodgkin's lymphoma after failure of autologous stem cell transplant | 8/19/2011 | 10:00 - Antineoplastic Agents | ||
| Firazyr® | icatibant | Shire | acute attacks of hereditary angioedema (HAE) in adults | 8/25/2011 | 92:32 - Complement Inhibitors | ||
| Kalbitor® | ecallantide | Dyax | acute attacks of hereditary angioedema (HAE) in adults | 8/25/2011 | change: from 92:92 to 92:32 - Complement Inhibitors | ||
| Xalkori® | crizotinib | Pfizer | non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive | 8/26/2011 | 10:00 - Antineoplastic Agents | ||
| Daliresp® | roflumilast | Forest | severe COPD associated with chronic bronchitis | 9/27/2011 | change: from 48:92 to new class 48:32 - Phosphodiesterase Type 4 Inhibitors | ||
| 9/27/2011 | change: 24:12.12 name from Phosphodiesterase Inhibitors to Phosphodiesterase Type 5 Inhibitors | ||||||
| Ferriprox® | deferiprone | Apopharma | transfusional iron overload | 10/14/2011 | 64:00 - Heavy Metal Antagonists | ||
| Onfi® | clobazam | Lundbeck | seizures associated with Lennox-Gastaut syndrome | 10/21/2011 | 28:12.08 - Benzodiazepines | ||
| Jakafi® | ruxolitinib | Incyte | intermediate or high-risk myelofibrosis | 11/16/2011 | 10:00 - Antineoplastic Agents | ||
| Erwinaze® | asparaginase (Erwinia chrysanthemi) | EUSA Pharma | acute lymphoblastic leukemia (ALL) in E. coli-derived hypersensitive patients | 11/18/2011 | 10:00 - Antineoplastic Agents | ||
| Eylea® | aflibercept | Regeneron | neovascular age-related macular degeneration (AMD) | 11/18/2011 | 52:92 - EENT Drugs, Miscellaneous |
| AHFS Class | Retired | Change Description |
|---|---|---|
| 8:12.06.20 |
- | New classification (Fifth Generation Cephalosporins) |
| 8:18.40 |
- | New classification (Protease Inhibitors) |
| 26:00 |
- | New classification (Cellular Therapy) |
| 36:70 |
- | New classification (Respiratory Function) |
| 40:28.28 |
- | New classification (Vasopressin Antagonists) |