CDER Drug Safety Labeling Changes - 6/28/2021

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 AYVAKIT AVAPRITINIB 212608 NDA 06/16/2021 06/17/2021 CYRAMZA RAMUCIRUMAB 125477 BLA 06/15/2021 06/17/2021 LYSODREN MITOTANE 016885 NDA 06/15/2021 06/17/2021 PROPECIA FINASTERIDE 020788 NDA 06/15/2021 06/17/2021 PROSCAR FINASTERIDE 020180 NDA 06/15/2021 06/17/2021 ZELAPAR SELEGILINE HYDROCHLORIDE 021479 NDA 06/16/2021 06/17/2021 PRADAXA DABIGATRAN ETEXILATE MESYLATE 022512 NDA 06/21/2021 06/22/2021 BYETTA EXENATIDE SYNTHETIC 021773 NDA 06/17/2021 06/24/2021 CALCIUM GLUCONATE CALCIUM GLUCONATE 208418 NDA 06/17/2021 06/24/2021 NOXAFIL POSACONAZOLE 205053 NDA 06/17/2021 06/24/2021 NOXAFIL POSACONAZOLE 205596 NDA 06/17/2021 06/24/2021 QINLOCK RIPRETINIB 213973 NDA 06/17/2021 06/24/2021 RIFADIN RIFAMPIN 050420 NDA 06/17/2021 06/24/2021 RIFADIN RIFAMPIN 050627 NDA 06/17/2021 06/24/2021 RIFATER ISONIAZID; PYRAZINAMIDE; RIFAMPIN 050705 NDA 06/17/2021 06/24/2021 SUBLOCADE BUPRENORPHINE 209819 NDA 06/17/2021 06/24/2021 TOVIAZ FESOTERODINE FUMARATE 022030 NDA 06/17/2021 06/24/2021 HEMANGEOL PROPRANOLOL HYDROCHLORIDE 205410 NDA 06/22/2021 06/25/2021 INFLECTRA INFLIXIMAB-DYYB 125544 BLA 06/17/2021 06/25/2021 BIJUVA ESTRADIOL; PROGESTERONE 210132 NDA 06/22/2021 06/27/2021 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