CDER Drug Safety Labeling Changes - 7/27/2021

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 BASAGLAR INSULIN GLARGINE 205692 BLA 07/20/2021 07/23/2021 BYDUREON EXENATIDE SYNTHETIC 022200 NDA 07/22/2021 07/23/2021 BYDUREON BCISE EXENATIDE 209210 NDA 07/22/2021 07/23/2021 DALVANCE DALBAVANCIN HYDROCHLORIDE 021883 NDA 07/22/2021 07/23/2021 KEYTRUDA PEMBROLIZUMAB 125514 BLA 07/21/2021 07/23/2021 LENVIMA LENVATINIB MESYLATE 206947 NDA 07/21/2021 07/23/2021 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 200534 NDA 07/21/2021 07/23/2021 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 200535 NDA 07/21/2021 07/23/2021 OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 201194 NDA 07/21/2021 07/23/2021 PIQRAY ALPELISIB 212526 NDA 07/20/2021 07/22/2021 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