Label Changes for:

Avandaryl (rosiglitazone maleate and glimepiride) Tablets

December 2008

Changes have been made to the BOXED WARNING, 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

BOXED WARNING

WARNINGS AND PRECAUTIONS

MEDICATION GUIDE (new)

BOXED WARNING

WARNINGS AND PRECAUTIONS

Note: package insert converted to the format prescribed by the Physician Labeling Rule (PLR), and the approved Patient Information converted to a Medication Guide. These changes are to be consistent with, but not identical to the changes approved for Avandia (rosiglitazone maleate) Tablets

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