Original New Drug Application (NDA and BLA) Approvals-November 2015
| Active Ingredient(s) | Company | Approval Date |
| MEPOLIZUMAB | GLAXOSMITHKLINE LLC | 11/04/2015 |
| ELVITEGRAVIR;COBICISTAT;EMTRICITABINE;TENOFOVIR ALAFENAMIDE | GILEAD SCIENCES INC | 11/05/2015 |
| HALOBETASOL PROPIONAT | FERNDALE LABS | 11/06/2015 |
| COBIMETINIB | GENENTECH INC | 11/10/2015 |
| OSIMERTINIB | ASTRAZENECA PHARMS | 11/13/2015 |
| DARATUMUMAB | JANSSEN BIOTECH | 11/16/2015 |
| NALOXONE HYDROCHLORIDE | ADAPT | 11/18/2015 |
| IXAZOMIB | MILLENNIUM PHARMS | 11/20/2015 |