Label Changes for:
Duetact (pioglitazone HCl plus glimepiride fixed-dose combination tablets), 30 mg/2 mg and 30 mg/4 mg
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- January 2009
|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.|
- Macrovascular Outcomes
- ...no clinical studies establishing conclusive evidence ...