CDER Drug Safety Labeling Changes - 6/11/2021

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 TRIKAFTA (COPACKAGED) ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR 212273 NDA 06/08/2021 06/10/2021 UDENYCA PEGFILGRASTIM-CBQV 761039 BLA 06/07/2021 06/09/2021 ULTOMIRIS RAVULIZUMAB-CWVZ 761108 BLA 06/07/2021 06/09/2021 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