CDER Drug Safety Labeling Changes - 3/3/2021

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 ACTEMRA TOCILIZUMAB 125276 BLA 02/28/2022 03/02/2022 ACTEMRA TOCILIZUMAB 125472 BLA 02/28/2022 03/02/2022 AKTEN LIDOCAINE HYDROCHLORIDE 022221 NDA 02/28/2022 03/02/2022 BLENREP BELANTAMAB MAFODOTIN-BLMF 761158 BLA 02/28/2022 03/02/2022 BORTEZOMIB BORTEZOMIB 206927 NDA 02/28/2022 03/02/2022 FLUOROPLEX FLUOROURACIL 016988 NDA 02/28/2022 03/02/2022 MAYZENT SIPONIMOD FUMARIC ACID 209884 NDA 03/01/2022 03/02/2022 MYALEPT METRELEPTIN 125390 BLA 02/28/2022 03/02/2022 TETRACAINE HYDROCHLORIDE TETRACAINE HYDROCHLORIDE 208135 NDA 02/28/2022 03/02/2022 ULTANE SEVOFLURANE 020478 NDA 03/01/2022 03/02/2022 XARELTO RIVAROXABAN 202439 NDA 03/01/2022 03/02/2022 XARELTO RIVAROXABAN 022406 NDA 03/01/2022 03/02/2022 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