NDA/BLAs approved by the FDA in 2013 (ordered by approval date)
| Compound Name | DDI | PGx | HI/RI | Therapeutic Class | Approval Date | Reference |
|---|---|---|---|---|---|---|
| Alogliptin | Y | N | Y | Endocrinology | 01/25 | (FDA, 2013q) |
| Mipomersen | Y | N | Y (RI) | Endocrinology | 01/29 | (FDA, 2013m) |
| Pomalidomide | Y (in vitro) | N | N | Hematology/Oncology | 02/08 | (FDA, 2013u) |
| Ado-trastuzumab emtansine | Y (in vitro) | N | Y (RI) | Hematology/Oncology | 02/22 | (FDA, 2013l) |
| Ospemifene | Y | N | Y | Obstetrics/Gynecology | 02/26 | (FDA, 2013t) |
| Technetium Tc-99M tilmanocepta | N | N | N | Diagnostics | 03/13 | (FDA, 2013o) |
| Gadoterate meglumine | N | N | Y (RI) | Diagnostics | 03/20 | (FDA, 2013f) |
| Dimethyl fumarate | Y | N | N | Neurology/Neurosurgery | 03/27 | (FDA, 2013x) |
| Canagliflozin | Y | N | Y | Endocrinology | 03/29 | (FDA, 2013k) |
| Fluticasone and vilanterol | Y | N | Y | Pulmonary/Critical Care | 05/10 | (FDA, 2013d) |
| Radium Ra 223 dichloridea | N | N | Yb | Hematology/Oncology | 05/15 | (FDA, 2013aa) |
| Dabrafenib | Y | N | N | Hematology/Oncology | 05/29 | (FDA, 2013w) |
| Trametinib | Y | N | Yb | Hematology/Oncology | 05/29 | (FDA, 2013p) |
| Afatinib | Y | N | Y (HI) | Hematology/Oncology | 07/12 | (FDA, 2013i) |
| Dolutegravir | Y | Y | Y | Infectious Disease | 08/12 | (FDA, 2013y) |
| Vortioxetine | Y | N | Y | Psychiatry | 09/30 | (FDA, 2013e) |
| Conjugated estrogens and bazedoxifene | Y | N | Y | Obstetrics/Gynecology | 10/03 | (FDA, 2013g) |
| Riociguat | Y | N | Y | Cardiology | 10/08 | (FDA, 2013a) |
| Macitentan | Y | N | Y | Cardiology | 10/18 | (FDA, 2013s) |
| Flutemetamol F-18a | N | N | N | Diagnostics | 10/25 | (FDA, 2013z) |
| Obinutuzumaba | N | N | Yb | Hematology/Oncology | 11/01 | (FDA, 2013h) |
| Eslicarbazepine acetate | Y | N | Y | Neurology/Neurosurgery | 11/08 | (FDA, 2013c) |
| Ibrutinib | Y | N | Y | Hematology/Oncology | 11/13 | (FDA, 2013j) |
| Luliconazole | Y | N | N | Infectious Disease | 11/14 | (FDA, 2013n) |
| Simeprevir | Y | N | Y | Gastroenterology | 11/22 | (FDA, 2013r) |
| Sofosbuvir | Y | N | Y | Gastroenterology | 12/06 | (FDA, 2013v) |
| Umeclidinium and vilanterol | Y | Y | Y | Pulmonary/Critical Care | 12/08 | (FDA, 2013b) |