New Drugs Approved_Nov.2015
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