Avandaryl (rosiglitazone maleate and glimepiride) Tablets

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. Read about the new physician labeling format.

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