CDER Drug Safety Labeling Changes - 11/30/2020

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 ATROPEN ATROPINE 017106 NDA 11/20/2020 11/24/2020 CEFAZOLIN AND DEXTROSE CEFAZOLIN SODIUM 050779 NDA 11/23/2020 11/25/2020 COSOPT DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE 020869 NDA 11/23/2020 11/25/2020 DOCETAXEL DOCETAXEL 022234 NDA 11/24/2020 11/25/2020 ERLEADA APALUTAMIDE 210951 NDA 11/20/2020 11/24/2020 IDHIFA ENASIDENIB MESYLATE 209606 NDA 11/24/2020 11/25/2020 NPLATE ROMIPLOSTIM 125268 BLA 11/23/2020 11/25/2020 NUPLAZID PIMAVANSERIN TARTRATE 207318 NDA 11/23/2020 11/25/2020 NUPLAZID PIMAVANSERIN TARTRATE 210793 NDA 11/23/2020 11/25/2020 PALYNZIQ PEGVALIASE-PQPZ 761079 BLA 11/20/2020 11/23/2020 POMALYST POMALIDOMIDE 204026 NDA 11/20/2020 11/25/2020 RYDAPT MIDOSTAURIN 207997 NDA 11/24/2020 11/25/2020 SOLIRIS ECULIZUMAB 125166 BLA 11/20/2020 11/23/2020 TEMODAR TEMOZOLOMIDE 021029 NDA 11/20/2020 11/25/2020 TEMODAR TEMOZOLOMIDE 022277 NDA 11/20/2020 11/25/2020 VENCLEXTA VENETOCLAX 208573 NDA 11/19/2020 11/24/2020 VICTOZA LIRAGLUTIDE RECOMBINANT 022341 NDA 11/20/2020 11/25/2020 XOFLUZA BALOXAVIR MARBOXIL 210854 NDA 11/23/2020 11/25/2020 ZIAGEN ABACAVIR SULFATE 020977 NDA 11/24/2020 11/25/2020 ZIAGEN ABACAVIR SULFATE 020978 NDA 11/24/2020 11/25/2020 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