CDER Drug Safety Labeling Changes

CDER Drug Safety Labeling Changes - 5/5/2026

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
AUVELITY	BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	215430	NDA	04/30/2026	05/04/2026
CRESTOR	ROSUVASTATIN CALCIUM	021366	NDA	04/29/2026	05/04/2026
NGENLA	SOMATROGON-GHLA	761184	BLA	04/29/2026	05/04/2026

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