CDER Drug Safety Labeling Changes - 10/29/2021

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 CUBICIN DAPTOMYCIN 021572 NDA 10/26/2021 10/28/2021 TEPEZZA TEPROTUMUMAB-TRBW 761143 BLA 10/26/2021 10/28/2021 ZYVOX LINEZOLID 021130 NDA 10/26/2021 10/28/2021 ZYVOX LINEZOLID 021131 NDA 10/26/2021 10/28/2021 ZYVOX LINEZOLID 021132 NDA 10/26/2021 10/28/2021 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