CDER Drug Safety Labeling Changes - 10/5/2021 - Healthy Food Deals

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 ADDYI FLIBANSERIN 022526 NDA 09/29/2021 10/01/2021 DUPIXENT DUPILUMAB 761055 BLA 10/01/2021 10/04/2021 EPIDIOLEX CANNABIDIOL 210365 NDA 09/30/2021 10/04/2021 HYCODAN HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 005213 NDA 09/27/2021 10/04/2021 JAKAFI RUXOLITINIB PHOSPHATE 202192 NDA 09/27/2021 10/01/2021 JENTADUETO XR LINAGLIPTIN; METFORMIN HYDROCHLORIDE 208026 NDA 10/01/2021 10/04/2021 MENOSTAR ESTRADIOL 020375 NDA 09/30/2021 10/04/2021 RUBRACA RUCAPARIB CAMSYLATE 209115 NDA 09/30/2021 10/04/2021 SOGROYA SOMAPACITAN-BECO 761156 BLA 10/01/2021 10/04/2021 TALICIA AMOXICILLIN; OMEPRAZOLE MAGNESIUM; RIFABUTIN 213004 NDA 10/01/2021 10/04/2021 TRULICITY DULAGLUTIDE 125469 BLA 09/30/2021 10/04/2021 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