Summary Company Announcement Date: December 16, 2024 FDA Publish Date: December 18, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains undeclared Metformin […]

On December 18, 2024, the Food and Drug Administration approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or […]

Compounded drugs are not FDA-approved. This means the agency does not verify their safety, effectiveness or quality before they are marketed. Compounded drugs can serve an […]

The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the […]

Alpha-1-antitrypsin deficiency(pulmonary disease or lung disease) Patients with congenital alpha-1 antitrypsin deficiency Plasma alpha-1 proteinase inhibitor Traditional Alpha-1 protease inhibitor augmentation Acid sphingomyelinase deficiency non–central nervous […]

Docket Number: FDA-2007-D-0434 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This document provides guidance to industry on postmarketing serious adverse event reporting […]

For Immediate Release: December 17, 2024 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the […]

12-16-2024 UpdateFDA adds a Boxed Warning, our most prominent warning, to highlight the known risk of rare but serious liver injury associated with use of menopause […]

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the key clinical trials that supported the original FDA approval of this drug, […]