CDER Drug Safety Labeling Changes - 7/6/2022

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 AUGMENTIN ES-600 AMOXICILLIN; CLAVULANATE POTASSIUM 050755 NDA 06/30/2022 07/05/2022 DHIVY CARBIDOPA; LEVODOPA 214869 NDA 06/30/2022 07/05/2022 KYPROLIS CARFILZOMIB 202714 NDA 06/30/2022 07/05/2022 LEVEMIR INSULIN DETEMIR RECOMBINANT 021536 BLA 07/01/2022 07/05/2022 LEVEMIR FLEXPEN INSULIN DETEMIR RECOMBINANT 021536 BLA 07/01/2022 07/05/2022 LEVEMIR FLEXTOUCH INSULIN DETEMIR RECOMBINANT 021536 BLA 07/01/2022 07/05/2022 LEVEMIR INNOLET INSULIN DETEMIR RECOMBINANT 021536 BLA 07/01/2022 07/05/2022 LEVEMIR PENFILL INSULIN DETEMIR RECOMBINANT 021536 BLA 07/01/2022 07/05/2022 TRESIBA INSULIN DEGLUDEC 203314 BLA 07/01/2022 07/05/2022 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