CDER Drug Safety Labeling Changes - 8/2/2021

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 NULOJIX BELATACEPT 125288 BLA 07/28/2021 07/30/2021 SOLIQUA 100/33 INSULIN GLARGINE; LIXISENATIDE 208673 BLA 07/28/2021 07/30/2021 VYVANSE LISDEXAMFETAMINE DIMESYLATE 021977 NDA 07/29/2021 07/30/2021 VYVANSE LISDEXAMFETAMINE DIMESYLATE 208510 NDA 07/29/2021 07/30/2021 Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA