CDER Drug Safety Labeling Changes - 5/27/2022

Drug Safety-related Labeling Changes (SrLC) The SrLC database has been updated with the following approved drug safety labeling changes. Drug Name Active Ingredient Application Number Application Type Supplement Date Database Updated CARAC FLUOROURACIL 020985 NDA 05/26/2022 05/27/2022 CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER   050639 NDA 05/20/2022 05/27/2022 DUPIXENT DUPILUMAB 761055 BLA 05/20/2022 05/27/2022 VIDAZA AZACITIDINE 050794 NDA 05/20/2022 05/27/2022 EMGALITY GALCANEZUMAB-GNLM 761063 BLA 05/24/2022 05/26/2022 REVLIMID LENALIDOMIDE 021880 NDA 05/24/2022 05/26/2022 TIBSOVO IVOSIDENIB 211192 NDA 05/25/2022 05/26/2022 YUPELRI REVEFENACIN 210598 NDA 05/25/2022 05/26/2022 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