CDER Drug Safety Labeling Changes - 8/12/2021

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 BRILINTA TICAGRELOR 022433 NDA 08/10/2021 08/12/2021 EVOMELA MELPHALAN HYDROCHLORIDE 207155 NDA 08/09/2021 08/12/2021 LENVIMA LENVATINIB MESYLATE 206947 NDA 08/10/2021 08/12/2021 XADAGO SAFINAMIDE MESYLATE 207145 NDA 08/09/2021 08/09/2021 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