New Molecular Entity and New Therapeutic Biological Product Approvals Drug Name Active Ingredient Date FDA-approved use on approval date Daklinza daclatasvir 7/24/2015 To treat chronic hepatitis C virus (HCV) genotype 3 infections Odomzo sonidegib 7/24/2015 To treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation […]
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