CDER Drug Safety Labeling Changes - 3/16/2021

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 DARZALEX DARATUMUMAB 761036 BLA 03/12/2021 03/15/2021 DARZALEX FASPRO DARATUMUMAB;HYALURONIDASE-FIHJ 761145 BLA 03/12/2021 03/15/2021 ELMIRON PENTOSAN POLYSULFATE SODIUM 020193 NDA 03/12/2021 03/15/2021 ZIEXTENZO PEGFILGRASTIM-BMEZ 761045 BLA 03/12/2021 03/15/2021 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