CDER Drug Safety Labeling Changes - 7/29/2022

Drug Safety-related Labeling Changes (SrLC) The SrLC database has been updated with the following approved drug safety labeling changes. Drug Name Active Ingredient Application Number Application Type Supplement Date Database Updated BENLYSTA BELIMUMAB 125370 BLA 07/26/2022 07/28/2022 BENLYSTA BELIMUMAB 761043 BLA 07/26/2022 07/28/2022 BYDUREON EXENATIDE SYNTHETIC 022200 NDA 07/26/2022 07/28/2022 BYDUREON BCISE EXENATIDE 209210 NDA 07/26/2022 07/28/2022 DORYX DOXYCYCLINE HYCLATE 050795 NDA 07/25/2022 07/28/2022 DORYX MPC DOXYCYCLINE HYCLATE 050795 NDA 07/25/2022 07/28/2022 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