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Label Changes for:

Lipofen (fenofibrate) Capsules

December 2008

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- December 2008


The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

Summary View


Sections Modified

Summary of Changes to Contraindications and Warnings


  • Other Considerations


  • Venothromboembolic Disease


  • ...the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study was

The latest label (approved 12/12/2008) is not available on this site