US FDA

CDER Drug Safety Labeling Changes - 2/12/2024

US FDA sent this email to their subscribers on February 12, 2024.

ADMINISTRATION RN LR LU

Drug Safety-related Labeling Changes (SrLC)

The SrLC database has been updated with the following approved drug safety labeling changes.


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Text-only version of this email

ADMINISTRATION RN LR LU 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 BLINCYTO BLINATUMOMAB 125557 BLA 02/08/2024 02/09/2024 SOLIRIS ECULIZUMAB 125166 BLA 02/09/2024 02/09/2024 TRACLEER BOSENTAN 021290 NDA 02/08/2024 02/09/2024 TRACLEER BOSENTAN 209279 NDA 02/08/2024 02/09/2024 ULTOMIRIS RAVULIZUMAB-CWVZ 761108 BLA 02/08/2024 02/09/2024 VYTORIN EZETIMIBE; SIMVASTATIN 021687 NDA 02/08/2024 02/09/2024 feedtwitterfacebookyoutubeflickr Manage Subscriptions  |   |  Help ---------------------------------------------------------------------------------------------------------------------------------- This email was sent to [email protected] 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 GovDelivery logo
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