CDER Drug Safety Labeling Changes - 6/4/2021

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 AKYNZEO FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE 210493 NDA 06/02/2021 06/03/2021 DOLOPHINE HYDROCHLORIDE METHADONE HYDROCHLORIDE 006134 NDA 06/02/2021 06/03/2021 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 017058 NDA 06/02/2021 06/03/2021 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 021624 NDA 06/02/2021 06/03/2021 METHADOSE METHADONE HYDROCHLORIDE 017116 NDA 06/02/2021 06/03/2021 Monjuvi (tafasitamab-cxix) for injection TAFASITAMAB-CXIX 761163 BLA 06/02/2021 06/03/2021 NOXAFIL POSACONAZOLE 205053 NDA 05/31/2021 06/03/2021 RAXIBACUMAB RAXIBACUMAB 125349 BLA 06/02/2021 06/03/2021 VYNDAMAX TAFAMIDIS 212161 NDA 06/01/2021 06/03/2021 VYNDAQEL TAFAMIDIS MEGLUMINE 211996 NDA 06/01/2021 06/03/2021 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