CDER Drug Safety Labeling Changes - 7/15/2021

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 AIRDUO RESPICLICK FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE 208799 NDA 07/09/2021 07/13/2021 ARMONAIR RESPICLICK FLUTICASONE PROPIONATE 208798 NDA 07/09/2021 07/13/2021 DARZALEX DARATUMUMAB 761036 BLA 07/09/2021 07/14/2021 DARZALEX FASPRO DARATUMUMAB;HYALURONIDASE-FIHJ 761145 BLA 07/09/2021 07/13/2021 JULUCA DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE 210192 NDA 07/09/2021 07/13/2021 PADCEV ENFORTUMAB VEDOTIN-EJFV 761137 BLA 07/09/2021 07/13/2021 PARLODEL BROMOCRIPTINE MESYLATE 017962 NDA 07/12/2021 07/14/2021 POTELIGEO MOGAMULIZUMAB-KPKC 761051 BLA 07/08/2021 07/14/2021 TIVICAY DOLUTEGRAVIR SODIUM 204790 NDA 07/09/2021 07/13/2021 VISUDYNE VERTEPORFIN 021119 NDA 07/09/2021 07/13/2021 WELLBUTRIN XL BUPROPION HYDROCHLORIDE 021515 NDA 07/08/2021 07/14/2021 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