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 |