CDER Drug Safety Labeling Changes - 1/27/2021

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 DARZALEX FASPRO DARATUMUMAB;HYALURONIDASE-FIHJ 761145 BLA 01/21/2022 01/26/2022 DOVATO DOLUTEGRAVIR SODIUM; LAMIVUDINE 211994 NDA 01/20/2022 01/23/2022 NUCALA MEPOLIZUMAB 125526 BLA 01/22/2022 01/26/2022 SKYRIZI RISANKIZUMAB-RZAA 761105 BLA 01/21/2022 01/26/2022 VEKLURY REMDESIVIR 214787 NDA 01/21/2022 01/24/2022 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