CDER Drug Safety Labeling Changes - 4/13/2021

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 DEFINITY PERFLUTREN 021064 NDA 04/09/2021 04/12/2021 LUMASON SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES 203684 NDA 04/09/2021 04/12/2021 XOLAIR OMALIZUMAB 103976 BLA 04/09/2021 04/12/2021 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