CDER Drug Safety Labeling Changes: Update: 09/09/2020

Drug Safety-related Labeling Changes (SrLC)

The SLC database has been updated with the following approved drug safety labeling changes.

Drug Name	Active Ingredient	Application Number	Application Type	Supplement Date	Database Updated
CORLOPAM	FENOLDOPAM MESYLATE	019922	NDA	09/02/2020	09/08/2020
ERLEADA	APALUTAMIDE	210951	NDA	09/01/2020	09/08/2020
LOVAZA	OMEGA-3-ACID ETHYL ESTERS	021654	NDA	09/04/2020	09/08/2020
NITYR	NITISINONE	209449	NDA	09/02/2020	09/08/2020
PIQRAY	ALPELISIB	212526	NDA	09/01/2020	09/08/2020
TRULICITY	DULAGLUTIDE	125469	BLA	09/03/2020	09/08/2020
VFEND	VORICONAZOLE	021266	NDA	09/04/2020	09/08/2020
VFEND	VORICONAZOLE	021630	NDA	09/04/2020	09/08/2020
VFEND	VORICONAZOLE	021267	NDA	09/04/2020	09/08/2020
XALATAN	LATANOPROST	020597	NDA	09/01/2020	09/08/2020