New Drugs Approved_Nov.2015

Original New Drug Application (NDA and BLA) Approvals-November 2015

Active Ingredient(s)CompanyApproval Date
MEPOLIZUMABGLAXOSMITHKLINE LLC11/04/2015
ELVITEGRAVIR;COBICISTAT;EMTRICITABINE;TENOFOVIR ALAFENAMIDEGILEAD SCIENCES INC11/05/2015
HALOBETASOL PROPIONATFERNDALE LABS11/06/2015
COBIMETINIBGENENTECH INC11/10/2015
OSIMERTINIBASTRAZENECA PHARMS11/13/2015
DARATUMUMABJANSSEN BIOTECH11/16/2015
NALOXONE HYDROCHLORIDEADAPT11/18/2015
IXAZOMIBMILLENNIUM PHARMS11/20/2015

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