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Label Changes for:

Simcor (simvastatin/niacin extended-release) Tablet, Film Coated, Extended Release for Oral Use

July 2008

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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


  • Overview
    • In a controlled clinical study, 14% of patients randomized to Simcor discontinued therapy due to an adverse event...